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

Catalog Number	130-32-53
Medical Device Problem Codes	Naturally Worn (2988); Insufficient Device Problem Information (3190)
Health Effect - Clinical Codes	Cyst(s) (1800); Osteolysis (2377); Insufficient Information (4580)
Date of Event	05/16/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported via legal documentation that a patient had a total hip arthroplasty on (b)(6) 2018 and has a planned revision procedure for (b)(6) 2024.There is no other information provided or available.
Additional Manufacturer Narrative
H10.D10.Concomitants: (b)(6), 180-01-58 - crown cup,cluster-hole gr.58, 17dm02067, 71343212 s&n oxinium 32mm o.D., +12 12/14 taper femoral head.B1708473, 11 000 430 s&n l-plus/integration plus stem with ti/ha cone 12/14 size 7, h3.Investigation results - the crown cup inlay neutral gr.3,32mm with serial number (b)(6) is confirmed to have been packaged in a vacuum bag that does not contain evoh.The cause of the patient's condition and planned revision surgery as related to the devices cannot be conclusively determined, insufficient information.These devices are used for treatment not diagnosis.There is no other information available.
Additional Manufacturer Narrative
Additional manufacturer narrative- pending investigation.There is no additional information available.
Event or Problem Description
As part of the manufacturer's recall campaign, the patient came in for a check-up.The x-ray and ct scan showed a clear decentration of the prosthesis head and small osteolysis in the acetabulum as signs of inlay wear.This was verified when the inlay was changed.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 the prosthesis head was replaced".There is no additional information available.
Additional Manufacturer Narrative
*the following sections have corrected information: (h3) 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.

• Brand Name: NV GXL LNR, NEUTRAL, 32MM ID, GROUP 3 CUPS
• Common Device Name: PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/CERAMIC/POLYMER, CEMENTED OR NON-POROUS
• Manufacturer (Section D): EXACTECH, INC.; 2320 nw 66 court; gainesville FL 32653
• Manufacturer (Section G): EXACTECH INC.; 2320 nw 66th court; gainesville FL 32653
• Manufacturer Contact: geoff gannon ; 2320 nw 66th ct; gainesville, FL 32653
• MDR Report Key: 19176089
• Report Number: 1038671-2024-00965
• Device Sequence Number: 19782638
• Product Code: LZO
• 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: 2018
• Device Explanted Year: 2024
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Company Representative
• Initial Reporter Occupation: Physician
• Remedial Action: Recall
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 09/04/2024

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: 05/31/2022
• 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: 04/11/2024
• Supplement Date Received by Manufacturer: 06/03/2024; 08/16/2024
• Initial Report FDA Received Date: 04/24/2024
• Supplement Report FDA Received Date: 06/13/2024; 09/04/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 06/01/2017
• 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: Initial
• If action reported to FDA under 21 USC 360i(g), list FDA-assigned Recall Number or include a statement: Z-1729-2022
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: SEE H10
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 54 YR
• Patient Sex: Male