MAUDE Adverse Event Report: EXACTECH, INC. ACUMATCH EXT COV LINER 28MM 54/56MM; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, CEMENTED

Catalog Number 134-28-08

Device Problem Naturally Worn (2988)

Patient Problem Failure of Implant (1924)

Event Date 01/09/2024

Event Type  Injury  

Event Description

As reported, the patient has a history of a right tha done approximately 20 years ago.The patient presented for right hip pain and was found to have poly wear in his right hip.He denies any start up pain or pain with weightbearing, however, the hip feels "tight" and it has been increasingly bothersome and reducing his ability to ambulate and hunt.He has been very active doing a lot of hunting.He states that on his last pheasant hunt he had to cut it short because of right hip pain.He indicates the pain is in the right groin and buttock area.Some pain in thigh and stiffness in the knee.No specific injury.No fevers or chills.The patient was scheduled for revision surgery on (b)(6) 2024.

Manufacturer Narrative

H3: pending investigation.D10: 100-28-00 - 0360853 - cocr femoral head 28mm +0mm neck.114-10-02 - 0355041.120-00-58 ¿ 0412310.H7: z-2124-2021.

• Brand Name: ACUMATCH EXT COV LINER 28MM 54/56MM
• 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 66th ct; gainesville FL 32653
• Manufacturer Contact: michael crader ; 2320 nw 66th ct; gainesville, FL 32653 ; 3523771140
• MDR Report Key: 18592806
• MDR Text Key: 333898223
• Report Number: 1038671-2024-00133
• Device Sequence Number: 1
• Product Code: JDI
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K993082
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Physician
• Remedial Action: Recall
• Type of Report: Initial
• Report Date: 01/27/2024

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 Expiration Date: 06/25/2007
• Device Catalogue Number: 134-28-08
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 01/10/2024
• Initial Date FDA Received: 01/27/2024
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 07/08/2002
• 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
• Patient Age: 77 YR
• Patient Sex: Male