The Hospital for Special Surgery and the femoral components

analysisThe Judicial Panel on Multidistrict Litigation noted the plaintiffs' point that the Hospital for Special Surgery, where witnesses on the Optetrak knee were located, had a collaborative relationship with Exactech since 1992. ¹

analysisThe complaint states that on August 4, 2017 HSS told Gary Miller of a "badly worn GXL acetabular insert" that seemed to have oxidised considerably more than other makers' crosslinked polyethylene, apparently the first of its oxidation complaints. It alleges that in October 2018, with Binder's direction, William Petty emailed several HSS surgeons a letter warning that presenting data on delamination and oxidation of Exactech polyethylene would damage both institutions and urging HSS to withdraw the presentation, and that HSS removed all Exactech PS knee implants from its inventory on February 9, 2019 and pulled the Equinoxe shoulder on February 17, 2021, having implanted over 15,000 Exactech moulded polyethylene inserts in 20 years. The trust alleges that Binder, Schilling and other TPG defendants sought to deter HSS from disclosing the problems and to conceal what the board and TPG knew as early as 2018, delaying the recalls. These are allegations in the Settlement Trust’s pending complaint and have not been adjudicated. TPG has denied wrongdoing, and Binder has said that Exactech discovered the packaging non-conformity in 2021 through its own complaint investigations and reported it to FDA. ¹

analysisThe complaint states that the unsecured creditors' committee found that from late 2004 until November 17, 2021 Exactech made femoral knee components to an incorrect non-articulating surface roughness specification, potentially affecting up to 371,986 devices, while outside manufacturers had read the ambiguous specification correctly, and that a March 31, 2021 health hazard evaluation confirmed that cement de-bonding was likely caused by a finish too smooth for the cement to hold. These are allegations in the Settlement Trust’s pending complaint and have not been adjudicated. No response by Exactech, TPG or Binder on this issue was found in the retained records. ¹