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
Medical Device Problem Code	Naturally Worn (2988)
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	11/21/2022
Type of Reportable Event	Serious Injury
Additional 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 or Problem 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).
Additional 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
• 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 ct; gainesville FL 32653
• Manufacturer Contact: matt collins ; 2320 nw 66th ct; gainesville, FL 32653 ; 3523771140
• MDR Report Key: 19148056
• Report Number: 1038671-2024-00913
• Device Sequence Number: 7406347
• Product Code: JDI
• UDI-Device Identifier: 10885862023407
• UDI-Public: 10885862023407
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K051556
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Device Explanted Year: 2022
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Remedial Action: Recall
• Type of Report: Initial,Followup
• Report Date (Section B): 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
• Operator of Device: Health Professional
• Device Expiration Date: 11/11/2024
• Device Catalogue Number: 132-36-29
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: 05/07/2024
• Initial Report FDA Received Date: 04/19/2024
• Supplement Report FDA Received Date: 05/10/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 12/27/2019
• 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 H10
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown