MAUDE Adverse Event Report: ZIMMER BIOMET, INC. UNK TM MOD CUP; PROSTHESIS, HIP

Model Number N/A

Device Problems Loosening of Implant Not Related to Bone-Ingrowth (4002); Migration (4003)

Patient Problem Failure of Implant (1924)

Event Date 05/09/2022

Event Type  Injury  

Manufacturer Narrative

(b)(4).Reported event was confirmed due to the review of medical records.Radiographs were provided and reviewed by a health care professional.Review of the available records identified the following: eccentric positioning of the femoral stem with respect to the femur.Acetabular cup opponent appears normal.No periprosthetic lucencies.Bones appear well mineralized.Device history record (dhr) review was unable to be performed as the lot number of the device involved in the event is unknown.Root cause was unable to be determined as the necessary information to adequately investigate the reported event was not provided.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.Multiple mdr reports were filed for this event, please see associated reports: 0001822565 - 2022 - 01674.

Event Description

It was reported the patient underwent a right hip revision approximately 22 years post implantation due to stem & cup loosening and migration.No additional information.

• Brand Name: UNK TM MOD CUP
• Type of Device: PROSTHESIS, HIP
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 1800 w. center st.; warsaw IN 46580
• Manufacturer (Section G): ZIMMER BIOMET, INC.; 1800 w. center st.; warsaw IN 46580
• Manufacturer Contact: jennifer rapsavage ; 56 e. bell dr.; warsaw, IN 46582 ; 5745260384
• MDR Report Key: 14574476
• MDR Text Key: 293189560
• Report Number: 0001822565-2022-01675
• Device Sequence Number: 1
• Product Code: KWA
• 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: Health Professional,Distributor
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 06/02/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/02/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model 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: 05/13/2022
• 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
• Treatment: UNK HEAD; UNK LINER; UNK STEM
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Sex: Female
• Patient Weight: 79 KG