MAUDE Adverse Event Report: ZIMMER BIOMET, INC. ZB 12/14 COCR FRDM 36MM X +6 PROSTHESIS, HIP

Model Number N/A

Device Problem Device Dislodged or Dislocated (2923)

Patient Problems Hematoma (1884); Loss of Range of Motion (2032); Scar Tissue (2060); Joint Dislocation (2374); Muscle/Tendon Damage (4532)

Event Date 10/28/2021

Event Type  Injury  

Event Description

It was reported the patient underwent initial left hip hemiarthroplasty. The patient was converted to a total hip arthroplasty approximately 3 years later. The patient underwent head and liner exchange approximately 6 months later to recurrent dislocations. The patient was revised again approximately 3 weeks later due to recurrent dislocations and psoas tendon rupture. The head and liner were exchanged without complication. Attempts have been made and additional information on the reported event is unavailable at this time.

Manufacturer Narrative

(b)(4). Concomitant products: ref 110010245 lot 64866560 shell; ref 00-7850-013-00 lot 63992895 femoral stem. The device will not be returned for analysis, as the device was discarded; however, an investigation of the reported event is in progress. 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 - 2021 - 03250.

• Brand Name: ZB 12/14 COCR FRDM 36MM X +6
• 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: 12909578
• MDR Text Key: 281526912
• Report Number: 0001825034-2021-03251
• Device Sequence Number: 1
• Product Code: KWY
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K183457
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Distributor

Reporter Occupation

• Type of Report: Initial,Followup
• Report Date: 01/25/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/01/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes

Device Operator

• Device Model Number: N/A
• Device Catalogue Number: 802403605
• Device Lot Number: 3018288R01
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 01/25/2022
• 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: 12/01/2021 Patient Sequence Number: 1