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 Codes	Pain (1994); Osteolysis (2377); Insufficient Information (4580)
Date of Event	06/24/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(h3) pending evaluation.
Event or Problem Description
It was reported that this patient was revised due to poly wear.The initial implant date is unknown.No further information is available at this time.
Additional Manufacturer Narrative
(h3) the most likely cause for the reported revision due to prosthesis wear 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.(d10) concomitant device(s): (b)(6) 180-01-56 - crown cup, cluster-hole gr.56.*the following sections have corrected information: b5: describe event or problem.D1: brand name.
Event or Problem Description
It was reported that this male patient's hip was revised approximately 5 years 2 months post op.The patient had a hip prosthesis cup from exactech implanted in 2019.He came in for a check-up in (b)(6) 2023 because of pain that had been present for months with suspected loosening of the prosthesis.The x-ray and ct scan showed minimal decentration of the prosthesis head and unusually pronounced osteolysis in the acetabulum.A skeletal scintigraphy was performed to rule out loosening and then the indication for an inlay change was made.This was done in (b)(6) 2024 on a vit e-hardened specially approved inlay.As part of the replacement operation, in addition to the inlay exchange, the firm integrity of the socket was determined, the cysts in the socket were curettaged and filled using hydroxyapatite + calcium (ceramic bone void filler) and the prosthesis head was replaced.

• 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; 2320 nw 66th court; gainesville FL 32653
• Manufacturer Contact: geoff gannon ; 2320 nw 66th court; gainesville 32653 ; 3523771140
• MDR Report Key: 19619920
• Report Number: 1038671-2024-02154
• Device Sequence Number: 20403863
• 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: Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 08/28/2024

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: 07/25/2023
• Device Catalogue Number: 130-32-53
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/24/2024
• Supplement Date Received by Manufacturer: 08/12/2024
• Initial Report FDA Received Date: 06/26/2024
• Supplement Report FDA Received Date: 08/28/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 07/27/2018
• 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
• Concomitant Medical Products and Therapy/Usage Dates: SEE H11.
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown