MAUDE Adverse Event Report: ZIMMER BIOMET, INC. UNKNOWN HEAD PROSTHESIS, HIP

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Wound Dehiscence (1154)

Event Date 12/22/2020

Event Type  Injury  

Manufacturer Narrative

Cmp (b)(4). Customer has indicated that the product will not be returned to zimmer biomet for investigation as the product location is unknown. The investigation is in process. Once the investigation has been completed, a follow-up mdr will be submitted. Concomitant prodcuts: part # unknown / unknown liner/ lot # unknown part #unknown / unknown cup/ lot # unknown part #unknown / unknown stem/ lot # unknown (b)(6). Multiple mdr reports were filed for this event, please see associated reports: 0001825034 -2021 -00068.

Event Description

It was reported that during patient was revised one-month post implantation due to wound complications. Head and liner were revised. Attempts have been made and additional information on the reported event is unavailable at this time.

• Brand Name: UNKNOWN HEAD
• 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: 11176771
• MDR Text Key: 226999455
• Report Number: 0001825034-2021-00069
• Device Sequence Number: 1
• Product Code: KWA
• Combination Product (y/n): N
• Reporter Country Code: SF
• PMA/PMN Number: N/A
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,foreign,health pr

Reporter Occupation

• Type of Report: Initial,Followup
• Report Date: 02/03/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/15/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No

Device Operator

• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Event Location: No Information
• Date Manufacturer Received: 01/13/2021
• 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: Invalid Data

Patient Treatment Data

Date Received: 01/15/2021 Patient Sequence Number: 1