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

Model Number	NV GXL LNR, +5LAT, 32MM G2-52/54MM CUPS
Medical Device Problem Code	Naturally Worn (2988)
Health Effect - Clinical Codes	Failure of Implant (1924); Osteolysis (2377)
Date of Event	08/24/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Additional information, including the product investigation, will be submitted within 30 days of receipt.
Event or Problem Description
As reported by germany (bfarm# 25519/23) competent authorities, as part of the exactech company's recall campaign, the patient presented himself during our consultation hours for a follow-up check.There were complaints from the artificial hip joint implanted in 2018 on the right.A radiological check was carried out.There was a significant decentering of the head in the inlay with osteolysis of the socket interface as a sign of significant wear of the inlay.This could be verified when the inlay was changed on (b)(6) 2023 to a vitd-hardened, specially approved inlay (ref: 146-36-52, sn: (b)(6).As part of the replacement operation, in addition to replacing the inlay, the integrity of the socket was determined, the cysts in the socket were cured and sealed using allogeneic spongiosa, and the prosthesis head was replaced.Unfortunately, the explants were not photographed and are currently being microbiologically examined at the laboratory doctor's office.After completion of the examination, these are sent back to manufacturer for examination.Other findings/x-ray images/surgical reports are also made available if there is a release from the medical confidentiality obligation.
Additional Manufacturer Narrative
Section h10: (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.A number of variables including use error, implant positioning, implant size selection, and patient factors (fitness for surgery, biomechanics, activity level and local tissue oxidation potential) could have all contributed to the increased trend in wear/osteolysis related complaints.The most likely cause for the revision reported due to early prosthesis wear and osteolysis in (b)(4) is a combination of the risk factors specified in (b)(4).However, this cannot be confirmed from the reported information.
Additional Manufacturer Narrative
After a re-review of information pertaining to this event and investigation, the following sections g1, g3 h1, h2, h3 and h6 have been updated accordingly.(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.A number of variables including use error, implant positioning, implant size selection, and patient factors (fitness for surgery, biomechanics, activity level and local tissue oxidation potential) could have all contributed to the increased trend in wear/osteolysis related complaints.The most likely cause for the revision reported due to early prosthesis wear and osteolysis is a combination of the risk factors including, use error, implant positioning, implant size selection, and patient factors may have also been a contributing factor to the early prosthesis wear.However, this cannot be confirmed from the reported information.

• Brand Name: NV GXL LNR, +5LAT, 32MM G2-52/54MM CUPS
• Common Device Name: PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED
• Manufacturer (Section D): EXACTECH, INC.; 2320 nw 66 court; gainesville FL 32653
• Manufacturer (Section G): EXACTECH, INC.; 2320 nw 66 court; gainesville FL 32653
• Manufacturer Contact: geoff gannon ; gainesville, FL 32653 ; 3523771140
• MDR Report Key: 17751415
• Report Number: 1038671-2023-02272
• Device Sequence Number: 15268180
• Product Code: JWH
• UDI-Device Identifier: 10885862024282
• UDI-Public: 10885862024282
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: K070479
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Device Explanted Year: 2023
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 11/08/2024

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?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 06/20/2023
• Device Model Number: NV GXL LNR, +5LAT, 32MM G2-52/54MM CUPS
• Device Catalogue Number: 136-32-52
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: 12/13/2023; 11/01/2024
• Initial Report FDA Received Date: 09/14/2023
• Supplement Report FDA Received Date: 04/18/2024; 11/08/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 06/22/2018
• 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
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 59 YR
• Patient Sex: Male