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 Codes	Naturally Worn (2988); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Osteolysis (2377); Insufficient Information (4580)
Date of Event	07/04/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that a hip was revised.No further issues or complications were reported.No additional information is available.
Additional Manufacturer Narrative
(h3) pending evaluation.
Event or Problem Description
It was reported that the patient came in for a check-up.The x-ray and ct scan showed a clear decentration of the prosthesis head and unusually large osteolyses in the acetabulum as signs of inlay wear.This was verified when the inlay was changed to a vit e-hardened, specially approved inlay (novation xle +5mm lateralized liner, group2, 36 mm.As part of the replacement operation, in addition to the inlay exchange, the firm socket integrity was determined, the cysts in the socket were cured and filled using hydroxyapatite + calcium (cerament bone void filler) and the prosthesis head was changed.
Additional Manufacturer Narrative
(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 cause for the reported revision due to prosthesis wear and osteolysis is a combination of the risk factors specified in an hhe.However, this cannot be confirmed as the devices were not returned for evaluation, and images and radiographs were not provided.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional and/or corrected information.The following sections were updated/corrected: d1/d2a/d2b, d4, h4, h6.Mdr section codes updated/corrected: a, e.The most likely cause for the reported revision due to prosthesis wear and osteolysis is a combination of the 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).However, this cannot be confirmed as the devices were not returned for evaluation, and images and radiographs were not provided.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, +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; 2320 nw 66th court; gainesville FL 32653
• Manufacturer Contact: geoff gannon ; 2320 nw 66th court; gainesville, FL 32653 ; 3523771140
• MDR Report Key: 19840793
• Report Number: 1038671-2024-02565
• Device Sequence Number: 20572092
• 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: 2015
• Device Explanted Year: 2024
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 05/19/2025

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: 08/14/2018
• Device Catalogue Number: 136-32-52
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/08/2024
• Supplement Date Received by Manufacturer: 10/18/2024; 05/19/2025
• Initial Report FDA Received Date: 07/26/2024
• Supplement Report FDA Received Date: 11/08/2024; 05/19/2025
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 08/16/2013
• 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 Sex: Unknown