MAUDE Adverse Event Report: EXACTECH, INC. NV GXL LNR, +5LAT, 32MM G1-48/50MM CUPS; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, CEMENTED

Catalog Number	136-32-51
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	04/11/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Section h10: (h3) pending evaluation.(d10) concomitant device(s): 4283518 180-01-50 - crown cup,cluster-hole gr.50.
Event or Problem Description
It was reported that this patient had hip a prosthetic sockets from exactech implanted approximately 8 years posts op.As part of the manufacturer's recall campaign, the patient presented herself for a check-up.The x-ray and ct check showed a clear decentering of the prosthesis head on the left and unusually large osteolysis in the acetabulum as a sign of inlay wear.This could happen when the inlay was changed on (b)(6) 2024 vitd-hardened special approved inlay (novation xle +5mm lateralized liner, group 1, 32mm i.D.As part of the replacement operation, the inlay was replaced, determination of the solid cup integrity as well as the curettage and sealing of the cysts in the cup bed using allogeneic spongiosa and changing the prosthetic head.
Additional Manufacturer Narrative
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 combination of largest available femoral head and/or thinnest available acetabular liner was used.The most likely cause for the revision reported due to early prosthesis wear/osteolysis is a combination of the risk factors specified in an hhe.However, this cannot be confirmed from the reported information.

• Brand Name: NV GXL LNR, +5LAT, 32MM G1-48/50MM 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; 2320 nw 66th court; gainesville FL 32653
• Manufacturer Contact: matt collins ; 2320 nw 66th court; gainesville, FL 32653
• MDR Report Key: 19246455
• Report Number: 1038671-2024-01055
• Device Sequence Number: 7320873
• Product Code: JDI
• UDI-Device Identifier: 10885862024275
• UDI-Public: 10885862024275
• 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: 2016
• Device Explanted Year: 2024
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Remedial Action: Recall
• Type of Report: Initial,Followup
• Report Date (Section B): 08/07/2024

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: 04/11/2024
• Device Catalogue Number: 136-32-51
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/11/2024
• Supplement Date Received by Manufacturer: 07/16/2024
• Initial Report FDA Received Date: 05/06/2024
• Supplement Report FDA Received Date: 08/07/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 10/27/2015
• 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
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 75 YR
• Patient Sex: Female