MAUDE Adverse Event Report: EXACTECH, INC. NV GXL LNR, +5LAT, 36MM G2-52/54MM CUPS; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, CEMENTED

Catalog Number	136-36-52
Medical Device Problem Code	Naturally Worn (2988)
Health Effect - Clinical Codes	Failure of Implant (1924); Myalgia (2238); Osteolysis (2377); Implant Pain (4561)
Date of Event	01/16/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
As part of the manufacturer's recall campaign, the patient presented himself for a check-up of the device implanted in 2013 left hip prosthesis.The x-ray control showed a clear decentering of the prosthetic head a very large osteolysis in the acetabulum as a sign of inlay wear.There is an additional finding pronounced lumbar spine syndrome in polymyalgia rheumatica.During the revision surgery on (b)(6) 2023, he was able to radiological findings are confirmed.Because the socket was loose and osteolysis occurred due to the size then the complete socket change to a revision hip cup with tab and iliac pin.As part of the replacement operation, the changing the prosthetic head.
Additional Manufacturer Narrative
Pending investigation.2491734 180-01-54 - crown cup,cluster-hole gr.54 h7: z-2128-2021.
Additional Manufacturer Narrative
H3: the revision reported may have been the result of the orientation of the acetabular cup, edge loading/impingement, patient-related conditions, or any combination of these possibilities, which led to polyethylene wear and osteolysis after being implanted for 10+ years.It should also be noted that using both a lateralized liner and a group 2 acetabular liner with a 36mm femoral head creates a combination of the largest available head and the thinnest available acetabular liner (for group 2), which is a risk factor for early wear and lysis specified in the hhe.However, the reported wear and reason for revision cannot be confirmed as the devices were not available for evaluation and no pictures, radiographs, or medical records were provided at the time of this evaluation.
Additional Manufacturer Narrative
Based on the available information, the patient involved meets the following risk criteria for early prosthesis wear and/or osteolysis as specified in the hhe: implanted with a lateralized liner, combination of largest available femoral head and/or thinnest available liner was used.The most likely underlying cause for the revision reported is a combination of risk factors specified in the hhe and being implanted for more than 10 years.However, the reported prosthesis wear or loosening cannot be confirmed from the reported information and the devices were not available for evaluation.This follow-up report is being submitted to relay corrected information.This follow-up report is being submitted to relay additional information.

• Brand Name: NV GXL LNR, +5LAT, 36MM 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 66th ct; gainesville FL 32653
• Manufacturer Contact: michael crader ; 2320 nw 66th ct; gainesville, FL 32653 ; 3523771140
• MDR Report Key: 18650814
• Report Number: 1038671-2024-00158
• Device Sequence Number: 8107611
• Product Code: JDI
• UDI-Device Identifier: 10885862024329
• UDI-Public: 10885862024329
• 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: 2013
• Device Explanted Year: 2024
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Remedial Action: Recall
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 05/16/2025

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?: No
• Operator of Device: Health Professional
• Device Expiration Date: 11/04/2017
• Device Catalogue Number: 136-36-52
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/16/2024
• Supplement Date Received by Manufacturer: 04/15/2024; 05/14/2025
• Initial Report FDA Received Date: 02/06/2024
• Supplement Report FDA Received Date: 04/26/2024; 05/16/2025
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 11/07/2012
• 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
• Concomitant Medical Products and Therapy/Usage Dates: SEE H10
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown