MAUDE Adverse Event Report: ZIMMER BIOMET, INC. UNKNOWN HI-WALL LINER; PROTHESIS, HIP

Model Number N/A

Device Problem Naturally Worn (2988)

Patient Problems Failure of Implant (1924); Pain (1994)

Event Date 12/11/2023

Event Type  Injury  

Manufacturer Narrative

(b)(4).Product will not be returned to zimmer biomet for investigation.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.

Event Description

It was reported that the patient underwent a hip arthroplasty on an unknown date.Subsequently, the patient is being considered for a revision on an unknown date for poly wear.No additional information.

Manufacturer Narrative

This follow-up report is being submitted to relay additional information.Customer has indicated that the product will not be returned to zimmer biomet for investigation.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.

Event Description

It was reported that the patient had a right hip revision due to pain.It was determined via x-ray that the patient had poly wear on the liner.The liner was not identifiable upon explant; however, it was reported as an unknown liner that accepted a 32 head.No additional information was available.

Manufacturer Narrative

This follow-up report is being submitted to relay additional information.No product was returned, or pictures provided; visual and dimensional evaluation could not be performed.Radiographs were provided and reviewed by a health care professional.A review of the available records identified the following: complaint is for poly wear which is not visible on x-rays.The images did not enhance the investigation.Part and lot identification are necessary for review of device history records and compatibility checks, and neither were provided.The reported issue could not be confirmed.A definitive root cause cannot be determined.If any further information is found which would change or alter any conclusions or information, a supplemental will be filed accordingly.Zimmer biomet will continue to monitor for trends.

Event Description

No further event information is available at the time of this report.

• Brand Name: UNKNOWN HI-WALL LINER
• Type of Device: PROTHESIS, HIP
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; p.o. box 587; warsaw IN 46581
• Manufacturer (Section G): ZIMMER BIOMET, INC.; 56 e. bell drive; p.o. box 587; warsaw IN 46581
• Manufacturer Contact: jennifer rapsavage ; 56 e. bell dr.; warsaw, IN 46582 ; 5745260384
• MDR Report Key: 18328678
• MDR Text Key: 330513313
• Report Number: 0001825034-2023-02980
• Device Sequence Number: 1
• Product Code: LPH
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: NI
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Distributor
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 01/30/2024

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?: Yes
• Device Operator: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: UNKNOWN LINER
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 12/05/2023
• Initial Date FDA Received: 12/14/2023
• Supplement Dates Manufacturer Received: 01/02/2024; 01/30/2024
• Supplement Dates FDA Received: 01/03/2024; 01/31/2024
• 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
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Sex: Male