MAUDE Adverse Event Report: ZIMMER TMT STEM COLLAR 25MM OD USE WITH 16 MM OR SMALLER DIA SEGMENTAL STEM PROSTHESIS, KNEE

Model Number N/A

Device Problem Loosening of Implant Not Related to Bone-Ingrowth (4002)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 04/23/2021

Event Type  Injury  

Manufacturer Narrative

(b)(4). Customer has indicated that the product will not be returned to zimmer biomet for investigation, as the device was discarded by the facility. The investigation is in process. Once the investigation has been completed, a follow-up mdr will be submitted.

Event Description

It was reported the patient has undergone multiple procedures. The current zss construct had shown signs and symptoms of loosening. Surgeon plan was to remove existing implants and replace with new.

• Brand Name: STEM COLLAR 25MM OD USE WITH 16 MM OR SMALLER DIA SEGMENTAL STEM
• Type of Device: PROSTHESIS, KNEE
• Manufacturer (Section D): ZIMMER TMT; 10 pomeroy road; parsippany NJ 07054
• Manufacturer (Section G): ZIMMER TMT; 10 pomeroy road; parsippany NJ 07054
• Manufacturer Contact: william hara ; 10 pomeroy road; parsippany, NJ 07054 ; 9735760032
• MDR Report Key: 12025535
• MDR Text Key: 257188639
• Report Number: 3005751028-2021-00051
• Device Sequence Number: 1
• Product Code: KRO
• Combination Product (y/n): N
• Reporter Country Code: AS
• PMA/PMN Number: K070978
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health

Reporter Occupation

• Type of Report: Initial,Followup
• Report Date: 08/12/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/18/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes

Device Operator

• Device Expiration Date: 01/31/2017
• Device Model Number: N/A
• Device Catalogue Number: 00585204025
• Device Lot Number: 61960736
• 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: 08/12/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/03/2012
• 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: 06/18/2021 Patient Sequence Number: 1