MAUDE Adverse Event Report: EXACTECH, INC. ACUMATCH GXL 15DEG LINER 36MM SZ J; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, CEMENTED

Catalog Number 132-36-29

Device Problem Naturally Worn (2988)

Patient Problem Failure of Implant (1924)

Event Date 11/21/2022

Event Type  Injury  

Manufacturer Narrative

D10: concomitant device: 5834507 100-36-00 - 36mm +0mm femoral head.H7: z-1728-2022.H3.The revision reported was likely the result of prosthesis wear of the tibial insert.The cause of prothesis wear is generally a combination of risk factors including use error, implant positioning, implant size selection, and patient factors.However, this cannot be conclusively determined with the information provided.

Event Description

It was reported via legal documentation that a patient had a right total hip on (b)(6) 2020 and was revised on (b)(6) 2022.Patient required revision surgery for issues including but not limited to polyethylene prosthesis wear, pain, component loosening and device failure.The mostly likely cause for the revision reported due to prothesis wear is a combination of risk factors including use error, implant positioning, implant size selection, and patient factors.However, this cannot be conclusively determined with the information provided.The serial number (b)(6) is confirmed to be a part of recall number: z-1728-2022 (b)(6) 132-36-29 - acumatch gxl 15deg liner 36mm sz j 510k: k051556 udi: (b)(4).Concomitant devices: 5834507 100-36-00 - 36mm +0mm femoral head.The serial number (b)(6) is confirmed to be a part of recall number: z-1728-2022.Serial: (b)(6).132-36-29 - acumatch gxl 15deg liner 36mm sz j 510k: k051556 udi: (b)(4).

Manufacturer Narrative

Please disregard the initial report as this event was found to be a duplicate of event reported under mfr# 1038671-2024-00563.

• Brand Name: ACUMATCH GXL 15DEG LINER 36MM SZ J
• Type of Device: 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 ct; gainesville FL 32653
• Manufacturer Contact: matt collins ; 2320 nw 66th ct; gainesville, FL 32653 ; 3523771140
• MDR Report Key: 19148056
• MDR Text Key: 340675358
• Report Number: 1038671-2024-00913
• Device Sequence Number: 1
• Product Code: JDI
• UDI-Device Identifier: 10885862023407
• UDI-Public: 10885862023407
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K051556
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Company Representative
• Reporter Occupation: Non-Healthcare Professional
• Remedial Action: Recall
• Type of Report: Initial,Followup
• Report Date: 05/10/2024

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?: No
• Device Operator: Health Professional
• Device Catalogue Number: 132-36-29
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 04/19/2024
• Supplement Dates Manufacturer Received: 05/07/2024
• Supplement Dates FDA Received: 05/10/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/27/2019
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: SEE H10
• Patient Outcome(s): Required Intervention