MAUDE Adverse Event Report: EXACTECH, INC. NV GXL LNR, 10 DEG FACE, 32MM ID, GRP 1 CUP; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, CEMENTED

Catalog Number	138-32-51
Medical Device Problem Code	Naturally Worn (2988)
Health Effect - Clinical Codes	Pain (1994); Discomfort (2330); Osteolysis (2377)
Date of Event	05/31/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
According to the information provided, the patient underwent a total right hip replacement and was implanted with a novation gxl acetabular liner.The patient underwent a second revision approximately 2 years and 2 months post the initial total hip arthroplasty due to prosthesis wear and/or loosening.It is unclear if the competitor femoral stem was found loose at this revision or if the loosening is referring to the exactech acetabular cup.The patient reportedly continues to experience severe pain and discomfort in their hip.
Additional Manufacturer Narrative
The reported event was unable to be confirmed due to limited information received from the customer.No device was returned for evaluation; further, photographs and/or radiograph images were not provided for review.A review of complaint history determined that no further action is required as no trends were identified.A definitive root cause was unable to be determined; however, may have resulted from result of prosthesis wear, osteolysis, and loosening that occurred over approximately 3 years and 10 months of use.The prothesis wear and osteolysis may have been due to a combination of risk factors specified in the hhe: combination of the largest available femora head and/or thinnest available acetabular liner was used and implanted with a component having a shelf age of greater than 2 years.The most likely underlying cause for the revision due to early prosthesis wear reported is a combination of risk factors specified, in addition to possible loosening of the acetabular cup.However, this cannot be confirmed from the information provided, the revised components were not returned to exactech for evaluation, and no images or radiographs were provided.It should also be noted that competitor parts were implanted on the femoral side.This is considered off-label use.If any further information is obtained that would change or alter any information provided, a supplemental report will be filed accordingly.

• Brand Name: NV GXL LNR, 10 DEG FACE, 32MM ID, GRP 1 CUP
• 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: ashley harris ; 2320 nw 66th ct; gainesville, FL 32653 ; 3523771140
• MDR Report Key: 25141530
• Report Number: 1038671-2026-00573
• Device Sequence Number: 9406745
• Product Code: JDI
• UDI-Device Identifier: 10885862024732
• UDI-Public: 10885862024732
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K070479
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Device Explanted Year: 2022
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Consumer,Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 05/11/2026

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: 10/17/2017
• Device Catalogue Number: 138-32-51
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/15/2023
• Initial Report FDA Received Date: 05/11/2026
• Date Device Manufactured: 10/23/2012
• 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
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Age: 63 YR
• Patient Sex: Unknown