MAUDE Adverse Event Report: EXACTECH, INC. NV GXL LNR, +5LAT, 32MM G2-52/54MM CUPS; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, CEMENTED

Catalog Number	136-32-52
Medical Device Problem Code	Naturally Worn (2988)
Health Effect - Clinical Codes	Cyst(s) (1800); Failure of Implant (1924); Osteolysis (2377)
Date of Event	08/30/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the patient presented for an inspection of the hip prosthesis implanted in 2019.The x-ray control showed a clear decentering of the prosthetic head and unusually large osteolysis in the acetabulum as a sign of inlay wear.This could be verified when the inlay was changed on (b)(6), 2023 to a vitd-hardened, specially approved inlay (novation xle +5mm lateralized liner group 2, 36mm id ref 146-36-52, sn (b)(6)).As part of the replacement operation, in addition to replacing the inlay, the firm integrity of the socket was determined, the cysts in the socket were cured and sealed using allogeneic spongiosa, and the head of the prosthesis was replaced.The explants are currently in the laboratory practice in osnabruck (rostocker str.5-7, 49124 georgsmarienhutte, tel.: 05401-33910) for microbiological examination using sonication.
Additional Manufacturer Narrative
Section h10: (h3) pending evaluation.
Additional Manufacturer Narrative
H3: based on the available information, the patient involved meets the following risk criteria for early prosthesis wear/osteolysis as specified in the hhe: implanted with a lateralized liner and implanted with a component having a shelf age of greater than 2 years.The revision reported was likely the result of a combination of both patient-related conditions and the risk factors specified in the hhe.However, this cannot be confirmed as the devices were not available for evaluation, and images and radiographs were not provided at the time of this evaluation.
Additional Manufacturer Narrative
*the following sections have corrected information: h6.

• Brand Name: NV GXL LNR, +5LAT, 32MM G2-52/54MM CUPS
• 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 66 ct; gainesville FL 32653
• Manufacturer Contact: kate jacobson ; 3523771140
• MDR Report Key: 17816711
• Report Number: 1038671-2023-02374
• Device Sequence Number: 16764354
• Product Code: JDI
• UDI-Device Identifier: 10885862024282
• UDI-Public: 10885862024282
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: Z-1729-2022
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Device Explanted Year: 2023
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Remedial Action: Recall
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 12/03/2024

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?: No
• Operator of Device: Health Professional
• Device Expiration Date: 03/06/2022
• Device Catalogue Number: 136-32-52
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/01/2023
• Supplement Date Received by Manufacturer: 03/17/2024; 11/19/2024
• Initial Report FDA Received Date: 09/26/2023
• Supplement Report FDA Received Date: 03/04/2024; 12/03/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 03/08/2017
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• If action reported to FDA under 21 USC 360i(g), list FDA-assigned Recall Number or include a statement: Z-1729-2022
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: UNK.
• Patient Sex: Male