MAUDE Adverse Event Report: EXACTECH, INC. BIOLOX DELTA FEMORAL HEAD 32MM OD, -3.5MM; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, CEMENTED

Catalog Number	170-32-93
Medical Device Problem Code	Naturally Worn (2988)
Health Effect - Clinical Codes	Pain (1994); Synovitis (2094); Osteolysis (2377); Swelling/ Edema (4577)
Date of Event	07/22/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The product associated with the reported event is within the scope of recall however, there is insufficient information to evaluate whether the subject issue of the recall was a cause or contributor to the reported event.The device was not returned for evaluation and no medical or other records containing treatment information or patient information have been received; therefore, the reported event cannot be confirmed, nor can the circumstances or potential causes or contributors to the alleged event be evaluated.Should additional, material information become available that permits more analysis or conclusions, a supplemental report will be filed accordingly.
Event or Problem Description
01-oct-2024 additional information" legal case ¿ usa (mdl no.3044) patient id: (b)(6) + right hip case-(b)(4) hip (unknown side) is associated with this case.It is reported via legal documentation the plaintiff underwent right hip replacement (b)(6) 2015 and underwent revision right hip (b)(6) 2024 (short form complaint attached).The patient has filed a short-form complaint in a multidistrict litigation titled in re: exactech polyethylene orthopedic products liability litigation, mdl no.3044, and pending in the eastern district of new york.Per the transfer order creating this multidistrict litigation, ¿plaintiffs¿allege that their knee or hip replacement devices¿failed prematurely because of degradation of the device¿s polyethylene component which resulted in the premature removal (or planned removal) of the prosthesis at issue.¿ because the patient has filed a suit in this multidistrict litigation, the patient appears to allege that the patient was injured as a result of premature wear of an exactech polyethylene device.The serial number (b)(6) is confirmed to be a part of recall number: z-1732-2022 130-32-51 - nv gxl liner neutral, 32mm id group 1 cups serial: (b)(6) 510k: k121392 udi: (b)(4) product code: jdi, lph, lwj, lzo, meh x-ray: no operative notes: no concomitant devices: (b)(6) 180-01-48 - nv crown cup clstr hole 48mm group 1 (b)(6) 170-32-00 - biolox delta femoral head 32mm od, +0mm (b)(6) 164-12-09 - novation element ro x/o sz 9 (b)(6) 120-65-25 - bone screw 6.5mm dia x 25mm long (b)(6) 101-05-30 - 3.2mm drill bit30mm 1pk original summary legal case ¿ usa letter of preservation patient id: (b)(6) + hip case-(b)(4) is associated with this case very important¿request for preservation of pathology materials and/or medical devices from upcoming procedure.
Additional Manufacturer Narrative
Based on the available information, the patient meets the following risk criteria for early prosthesis wear and/or osteolysis: implanted with a lateralized liner, combination of largest available femoral head and/or thinnest available acetabular liner was used, and implanted with a component having a shelf age of greater than 2 years.The most likely cause for the reported revision due to prosthesis wear and osteolysis may have been a combination of risk factors such as use error, implant positioning, implant size selection, and patient factors (fitness for surgery, biomechanics, activity level and local tissue oxidation potential).However, this cannot be confirmed as the devices were not returned for evaluation, and images and radiographs were not provided.H6: corrected component and investigation clinical codes.

• Brand Name: BIOLOX DELTA FEMORAL HEAD 32MM OD, -3.5MM
• Common Device Name: PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, CEMENTED
• Manufacturer (Section D): EXACTECH, INC.; 2320 nw 66 court; gainesville FL 32653
• Manufacturer (Section G): EXACTECH INC.; 2320 nw 66th court; gainesville 32653
• Manufacturer Contact: geoff gannon ; 2320 nw 66th court; gainesville 32653 ; 3523771140
• MDR Report Key: 20358640
• Report Number: 1038671-2024-03800
• Device Sequence Number: 7171340
• Product Code: JDI
• UDI-Device Identifier: 10885862153647
• UDI-Public: 10885862153647
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K103012
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2015
• Device Explanted Year: 2024
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 02/11/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 11/12/2018
• Device Catalogue Number: 170-32-93
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/01/2024
• Supplement Date Received by Manufacturer: 02/11/2025
• Initial Report FDA Received Date: 10/03/2024
• Supplement Report FDA Received Date: 02/11/2025
• Date Device Manufactured: 11/18/2013
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: SEE H11.
• Outcome Attributed to Adverse Event: Required Intervention; Hospitalization
• Patient Sex: Unknown