MAUDE Adverse Event Report: EXACTECH, INC. NV GXL LINER LIPPED 32MM ID, GROUP 1 CUPS; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, CEMENTED

Catalog Number	132-32-51
Medical Device Problem Code	Naturally Worn (2988)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	09/09/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that this patient was was revised approximately 6 years 7 months post op.The patient presented to surgeons office with poly wear shown on x-ray and a recalled implant.The patient had an acetabular poly liner and femoral head swap.There was no reported breakage of a device or surgical delay/prolongation.The patient left the or stable.
Additional Manufacturer Narrative
Pending investigation.D10: 5134271 170-32-00 - biolox delta femoral head 32mm od, +0mm; 5218769 186-01-50 - integrip cc, cluster 50mm, g1; 4917687 190-01-02 - alt ha noclr ext sz 2.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional and/or corrected information.The following sections were updated/corrected: h6 mdr section codes updated/corrected: b, c, d, g the most likely cause for the revision reported due to early prosthesis wear and osteolysis is a combination of the risk: such as use error, implant positioning, implant size selection, and patient factors (fitness for surgery, biomechanics, activity level and local tissue oxidation potential).Additionally, the sequence of events as related to the reported wear cannot be confirmed and the contributions of each to the reported event cannot be determined.The reported prosthesis wear is visible in the provided radiograph/image of the explanted devices.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 LINER LIPPED 32MM ID, GROUP 1 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: geoff gannon ; 2320 nw 66th ct; gainesville, FL 32653 ; 3523771140
• MDR Report Key: 20320784
• Report Number: 1038671-2024-03730
• Device Sequence Number: 7669392
• Product Code: JDI
• UDI-Device Identifier: 10885862207029
• UDI-Public: 10885862207029
• Combination Product (Y/N): N
• Initial Reporter State: IN
• Initial Reporter Country: US
• PMA/510(K) Number: K121392
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Device Explanted Year: 2024
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 08/29/2025

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?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 12/14/2022
• Device Catalogue Number: 132-32-51
• 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: 09/10/2024
• Supplement Date Received by Manufacturer: 08/25/2025
• Initial Report FDA Received Date: 09/27/2024
• Supplement Report FDA Received Date: 08/29/2025
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 12/16/2017
• 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
• Concomitant Medical Products and Therapy/Usage Dates: SEE H11.
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 59 YR
• Patient Sex: Female