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

Model Number N/A

Device Problem Naturally Worn (2988)

Patient Problem Failure of Implant (1924)

Event Date 07/12/2023

Event Type  Injury  

Event Description

It was reported that the patient had a revision surgery due to poly wear.It was reported that no additional information was available.

Manufacturer Narrative

(b)(4).G2: foreign: australia.Visual examination of the provided pictures identified the liner has damage and there is a hole worn through the liner.Complaint confirmed based on evaluation of provided image.Lot identification is necessary for review of device history records, lot identification was not provided.Complaint history review cannot be performed without product identification.Radiographs were provided and reviewed by a health care professional.Review of the available records identified the following: minimal superolateral eccentric positioning of the femoral component with respect to the central portion of the acetabular cup.Although not confirmed radiographically, this can be related to polyethylene wear.A definitive root cause cannot be determined.If any further information is found which would change or alter any conclusions or information, a supplemental report will be filed accordingly.Zimmer biomet will continue to monitor for trends.

• Brand Name: UNKNOWN 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: 17470899
• MDR Text Key: 320508772
• Report Number: 0001825034-2023-01828
• Device Sequence Number: 1
• Product Code: PBI
• Combination Product (y/n): N
• Reporter Country Code: AS
• PMA/PMN Number: N/A
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 08/04/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/07/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: N/A
• Device Catalogue Number: UNK LINER
• Device Lot Number: N/A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 07/13/2023
• Was Device Evaluated by Manufacturer?: Yes
• 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): Hospitalization; Required Intervention
• Patient Age: 84 YR
• Patient Sex: Female
• Patient Weight: 71 KG