MAUDE Adverse Event Report: EXACTECH, INC. ACUMATCH GXL 15DEG LINER 32MM SZ G; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/CERAMIC/POLYMER, CEMENTED OR NON-POROUS

Catalog Number 132-32-27

Device Problem Naturally Worn (2988)

Patient Problem Failure of Implant (1924)

Event Date 04/21/2023

Event Type  Injury  

Event Description

It was reported via legal documentation that a patient had a right hip implant on (b)(6) 2008, and then experienced a revision surgical procedure on (b)(6) 2023, approximately 14 years, 5 months after initial implant.There was no other patient/medical information provided.No x-rays or images were provided.The device will not be returned.There is no other information available.

Manufacturer Narrative

H10.D10.Concomitants - product information: (b)(6) 118-00-06 - p-ser 12/14 pf plasma collared sz 6; (b)(6) 120-01-52 - acumatch cluster cup porous coated 52mm; (b)(6) 148-32-93 - 12/14 zirconia head 32mm -3.5mm neck pending investigation.There is no other information available.

• Brand Name: ACUMATCH GXL 15DEG LINER 32MM SZ G
• Type of Device: 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: michael crader
• MDR Report Key: 18935071
• MDR Text Key: 338040425
• Report Number: 1038671-2024-00568
• Device Sequence Number: 1
• Product Code: LZO
• UDI-Device Identifier: 10885862023247
• UDI-Public: 10885862023247
• 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
• Report Date: 03/19/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/19/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 04/10/2012
• Device Catalogue Number: 132-32-27
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 10/13/2023
• Date Device Manufactured: 04/15/2008
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Removal/Correction Number: Z-1728-2022
• Patient Sequence Number: 1
• Treatment: SEE H10
• Patient Outcome(s): Required Intervention