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); Inflammation (1932); Synovitis (2094); Osteolysis (2377)
Date of Event	08/17/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
As reported, a radiological check was carried out and there was a considerable decentering of the head in the inlay, with osteolysis of the socket interface as a sign of clear wear of the inlay was impressive.This was verified when the inlay was changed on (b)(6) 2023.In addition to replacing the inlay, the integrity of the acetabulum was determined and cysts in the acetabulum were cured and sealed.Indication for implantation: post-traumatic coxarthrosis.
Additional Manufacturer Narrative
Pending investigation.H7: (b)(4).
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.The most likely cause for the revision reported due to prosthesis wear and osteolysis is a combination of the risk factors specified.However, this cannot be confirmed because the device was not returned for evaluation and images or radiographs were not provided.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay corrected information.The following sections were corrected: h3, h6.H3: 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.The most likely underlying cause for the revision reported is prosthesis wear and a combination of risk factors specified in the hhe and patient related conditions.However, this cannot be confirmed from the reported information and the devices were not available for evaluation.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional and/or corrected information.The following sections were updated/corrected: d6a.The most likely underlying cause for the revision reported is prosthesis wear and 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) and patient related conditions.However, this cannot be confirmed from the reported information and the devices were not available for evaluation.Should additional relevant information be obtained, a follow-up mdr will be submitted accordingly.

• 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 66th ct; gainesville FL 32653
• Manufacturer Contact: kate jacobson ; 2320 nw 66th ct; gainesville, FL 32653 ; 3523771140
• MDR Report Key: 17690172
• Report Number: 1038671-2023-02164
• Device Sequence Number: 12357034
• Product Code: JDI
• 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: 2017
• Device Explanted Year: 2023
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Physician
• Remedial Action: Recall
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 12/02/2025

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: 03/06/2022
• Device Catalogue Number: 136-32-52
• 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: 08/17/2023
• Supplement Date Received by Manufacturer: 01/16/2024; 07/02/2025; 12/01/2025
• Initial Report FDA Received Date: 09/06/2023
• Supplement Report FDA Received Date: 01/27/2024; 07/03/2025; 12/02/2025
• 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
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown