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U.S. Department of Health and Human Services

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

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ZIMMER TMT STEM COLLAR 25MM OD USE WITH 16 MM OR SMALLER DIA SEGMENTAL STEM PROSTHESIS, KNEE Back to Search Results
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.
 
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Brand NameSTEM COLLAR 25MM OD USE WITH 16 MM OR SMALLER DIA SEGMENTAL STEM
Type of DevicePROSTHESIS, 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 Key12025535
MDR Text Key257188639
Report Number3005751028-2021-00051
Device Sequence Number1
Product Code KRO
Combination Product (y/n)N
Reporter Country CodeAS
PMA/PMN Number
K070978
Number of Events Reported1
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 Received06/18/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date01/31/2017
Device Model NumberN/A
Device Catalogue Number00585204025
Device Lot Number61960736
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 Received08/12/2021
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured02/03/2012
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Removal/Correction NumberN/A

Patient Treatment Data
Date Received: 06/18/2021 Patient Sequence Number: 1
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