MAUDE Adverse Event Report: EXACTECH, INC. NV GXL LNR, NEUTRAL, 32MM ID, GROUP 3 CUPS; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, CEMENTED

Catalog Number	130-32-53
Medical Device Problem Codes	Naturally Worn (2988); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Failure of Implant (1924); Osteolysis (2377)
Date of Event	04/04/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that a male patient who had an initial left hip implanted on (b)(6) 2020, underwent a revision procedure on (b)(6) 2024, approximately 3 years 4 months post the initial procedure.The patient was revised due to polyethylene wear and was revised to a 140-36-53 cc inlay vitamin e, neutral, ø 36, gr.3 6600067.No further information.
Additional Manufacturer Narrative
H3: pending investigation.H7: z-2117-2021.
Event or Problem Description
The patient was fitted with hip prosthetic sockets from exactech on both sides in 2020 (left) and 2018 (right) implanted.As part of the manufacturer's recall campaign, the patient presented for a check-up.The x-ray and ct check showed a slight decentering of the prosthesis heads (left>right) with small osteolysis, acetabulum (left > right) as a sign of inlay wear.This was possible when the inlay was changed in (b)(6) 2024.As part of the replacement operation, the inlay was replaced, determination of the solid cup integrity as well as the curettage and sealing of the cysts in the cup bed using hydroxyapatite/calcium mixture (cerament bone void filler) and changing the prosthetic head.Right side revision reported under mdr# 1038671-2024-01595.
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 component having a shelf age of greater than 2 years.The most likely cause for the revision reported due to early prosthesis wear/osteolysis is a combination of the risk factors specified "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 because the device was not available 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 updated: h6 - investigation conclusion code.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional and/or corrected information.The most likely cause for the revision reported due to early prosthesis wear/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.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, NEUTRAL, 32MM ID, GROUP 3 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 ; 3525541928
• MDR Report Key: 19095163
• Report Number: 1038671-2024-00819
• Device Sequence Number: 7737088
• Product Code: JDI
• UDI-Device Identifier: 10885862022172
• UDI-Public: 10885862022172
• 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: 2020
• Device Explanted Year: 2024
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Remedial Action: Recall
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 05/15/2025

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: 08/01/2022
• Device Catalogue Number: 130-32-53
• 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: 04/05/2024
• Supplement Date Received by Manufacturer: 05/24/2024; 11/19/2024; 05/15/2025
• Initial Report FDA Received Date: 04/12/2024
• Supplement Report FDA Received Date: 07/20/2024; 12/10/2024; 05/15/2025
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 08/02/2017
• 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: A
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Male