MAUDE Adverse Event Report: EXACTECH, INC. ACUMATCH A SERIES; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, CEMENTED

Model Number ACUMATCH GXL 15DEG LINER 36MM SZ J

Device Problem Naturally Worn (2988)

Patient Problem Insufficient Information (4580)

Event Date 08/24/2022

Event Type  Injury  

Manufacturer Narrative

Additional information, including the product investigation, will be submitted within 30 days of receipt.

Event Description

It was reported that a male patient, who had an initial hip implanted, date unknown, and had a head liner revised on (b)(6) 2020, is probably going to have to be revised again for poly wear particulate issues.No further information.On (b)(6) 2020 head liner revision reported under mdr #1038671-2022-01155.

Manufacturer Narrative

The patient involved was reportedly experiencing prosthesis wear, following the index surgery.However, the patient was not yet revised, and no images or radiographs were provided.The prosthesis wear reported may have been due to a combination of risk factors specified including but not limited to use error, implant positioning, and patient factors.However, this cannot be confirmed from the reported information and the devices were not available for evaluation.

• Brand Name: ACUMATCH A SERIES
• 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, INC.; 2320 nw 66 court; gainesville FL 32653
• Manufacturer Contact: miguel sosa ; 2320 nw 66 court; gainesville, FL 32653 ; 3523164164
• MDR Report Key: 18932377
• MDR Text Key: 338080044
• Report Number: 1038671-2024-00563
• 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: Physician
• Remedial Action: Recall
• Type of Report: Initial,Followup
• Report Date: 03/28/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: ACUMATCH GXL 15DEG LINER 36MM SZ J
• Device Catalogue Number: 132-36-29
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 02/22/2024
• Initial Date FDA Received: 03/19/2024
• Supplement Dates Manufacturer Received: 03/27/2024
• Supplement Dates FDA Received: 03/28/2024
• Date Device Manufactured: 11/14/2019
• 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: 100-36-00 - 36MM +0MM FEMORAL HEAD 5834507
• Patient Outcome(s): Other
• Patient Sex: Male