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

Device Problem Naturally Worn (2988)

Patient Problem Failure of Implant (1924)

Event Date 06/27/2023

Event Type  Injury  

Event Description

As reported, approximately 11 years post op initial right tha, this female patient was revised due to wear of the liner.Patient had hip pain.Surgeon replaced the poly, head and screws.Patient was last known to be in stable condition following the event.Unable to obtain photos/x-rays.Product not returning - sterile processing disposed of implants.

Manufacturer Narrative

Section h10: (h3) pending evaluation.(d10) concomitant device(s): head.Screws.

Manufacturer Narrative

Section h10: (h3) the revision reported may have been the result of prosthesis wear that occurred over approximately 11 years of use.The prothesis wear may have been due to a combination of risk factors specified in and hhe 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: POLY
• 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 ct; gainesville FL 32653
• Manufacturer Contact: kate jacobson ; 2320 nw 66 ct; gainesville, FL 32653 ; 3523771140
• MDR Report Key: 18300162
• MDR Text Key: 330158523
• Report Number: 1038671-2023-02956
• Device Sequence Number: 1
• Product Code: JDI
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: UNK
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 04/23/2024

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
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/20/2023
• Initial Date FDA Received: 12/11/2023
• Supplement Dates Manufacturer Received: 04/03/2024
• Supplement Dates FDA Received: 04/23/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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: UNK.
• Patient Sex: Female