MAUDE Adverse Event Report: ZIMMER BIOMET, INC. UNK 12.5 MM TAPER LOCK STEM LATERAL OFFSET PROSTHESIS, HIP

Model Number N/A

Device Problems Corroded (1131); Patient Device Interaction Problem (4001)

Patient Problems Necrosis (1971); Pain (1994); Ambulation Difficulties (2544); Metal Related Pathology (4530)

Event Date 02/06/2020

Event Type  Injury  

Manufacturer Narrative

(b)(4). 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. Multiple mdr reports were filed for this event, please see associated reports: 0001825034 - 2022 - 00784, 0001825034 - 2022 - 00785.

Event Description

It was reported the patient underwent a left hip revision approximately 16 years post implantation due to pain, elevated metal ions, trendelenburg lurch, pseudotumor and abductor destruction. During the revision the trochanter was found bald with no abductors attached, no capsule, and appeared dead. Metal debris was inside of head and on the cup with mild trunnionosis. The head was exchanged without complications. The stem and cup remained implanted. Attempts have been made and no further information has been provided.

• Brand Name: UNK 12.5 MM TAPER LOCK STEM LATERAL OFFSET
• Type of Device: PROSTHESIS, HIP
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• Manufacturer (Section G): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• Manufacturer Contact: christina arnt ; 56 e. bell dr.; warsaw, IN 46582 ; 5745273773
• MDR Report Key: 13976295
• MDR Text Key: 288375973
• Report Number: 0001825034-2022-00783
• 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: Consumer,Health Professional

Reporter Occupation

• Type of Report: Initial,Followup
• Report Date: 05/09/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/01/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes

Device Operator

• 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: 04/26/2022
• 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 Treatment Data

Date Received: 04/01/2022 Patient Sequence Number: 1

Treatment

UNK 38 MM COBALT-CHROME HEAD; UNK 48 MM PRESS-FIT CUP