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

Catalog Number	130-32-51
Medical Device Problem Code	Naturally Worn (2988)
Health Effect - Clinical Code	Osteolysis (2377)
Date of Event	08/29/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that this male patient's hip was revised approximately 3 years 9 months post op.As part of the manufacturer's recall, the patient came in for a check-up.The x-ray and ct scans showed a clear decentration of the prosthesis head and small osteolyses in the acetabulum as signs of inlay wear.This was verified when the inlay was changed on (b)(6) 2024 to a vit e-hardened specially approved inlay (novation xle, neutral liner, group 1, 32 mm).As part of the replacement operation, in addition to the inlay exchange, the firm cup integrity was determined and the prosthesis head was replaced.
Additional Manufacturer Narrative
(h3) pending evaluation (d10) concomitant device(s): (b)(6) 180-01-48 - crown cup,cluster-hole gr.48.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional information.The following sections were updated: h3: 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.Operative notes and/or medical records were not provided for review of usage/ technique.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, based on the available information, the patient involved meets the following risk criteria for early prosthesis wear and/or osteolysis as specified in an hhe: combination of largest available femoral 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 cause for the reported revision due to prosthesis wear and osteolysis is a combination of the risk factors.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 LINER NEUTRAL, 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; 2320 nw 66th court; gainesville FL 32653
• Manufacturer Contact: geoff gannon ; 2320 nw 66th court; gainesville, FL 32653 ; 3523771140
• MDR Report Key: 20242390
• Report Number: 1038671-2024-03576
• Device Sequence Number: 7313123
• Product Code: JDI
• UDI-Device Identifier: 10885862207074
• UDI-Public: 10885862207074
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: K121392
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Device Explanted Year: 2024
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 12/26/2024

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: 07/26/2023
• Device Catalogue Number: 130-32-51
• 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: 09/09/2024
• Supplement Date Received by Manufacturer: 12/03/2024
• Initial Report FDA Received Date: 09/17/2024
• Supplement Report FDA Received Date: 12/26/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 07/30/2018
• 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
• Patient Sex: Female