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 Code	Naturally Worn (2988)
Health Effect - Clinical Code	Osteolysis (2377)
Date of Event	10/09/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Pending investigation.
Event or Problem Description
As reported, approximately 5 years and 1 month post initial implant, as part of the manufacturer's recall, the patient came in for a check-up.The x-ray and ct scans showed a slight decentration of the prosthesis head and small osteolyses in the acetabulum as signs of inlay wear.Revision surgery was then performed at which time this was verified when the inlay was changed to a vit e-hardened specially approved inlay.As part of the replacement operation, in addition to the inlay exchange, the firm cup integrity was determined, the cysts in the cup bed were cured and filled using hydroxyapatite + calcium (cerament bone void filler) and the prosthesis head was changed.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional and/or corrected information.The product associated with the reported event is within the scope of recall z-1729-2022; however, there is insufficient information to evaluate whether the subject issue of the recall was a cause or contributor to the reported event.The following sections were updated: h6 the following sections were corrected: b2 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, 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 ; 3523771140
• MDR Report Key: 20465418
• Report Number: 1038671-2024-03996
• Device Sequence Number: 7236144
• 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: 2019
• Device Explanted Year: 2024
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 01/13/2025

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: 07/04/2023
• 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: 10/11/2024
• Supplement Date Received by Manufacturer: 01/10/2025
• Initial Report FDA Received Date: 10/16/2024
• Supplement Report FDA Received Date: 01/13/2025
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 07/10/2018
• 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; Hospitalization
• Patient Sex: Male