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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ZIMMER TMT TM REVERSE BASE PLATE; PROSTHESIS, SHOULDER
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ZIMMER TMT TM REVERSE BASE PLATE; PROSTHESIS, SHOULDER Back to Search Results
Model Number N/A
Device Problem Migration or Expulsion of Device (1395)
Patient Problem No Information (3190)
Event Date 07/03/2018
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 location is unknown.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.Event occurred in (b)(6).
 
Event Description
It was reported that approximately 2.5 years post implantation, the patient was revised due to device migration.Attempts have been made and no further information has been provided.
 
Manufacturer Narrative
This follow-up report is being submitted to relay additional information.If any further information is found which would change or alter any conclusions or information, a supplemental will be filed accordingly.Zimmer biomet will continue to monitor for trends.
 
Event Description
No further event information available at the time of this report.
 
Manufacturer Narrative
Upon receipt of additional information, it has been determined that this device was reported for an incorrect manufacturing site mfr.The initial report was forwarded in error and should be voided.Please see 0001822565 - 2020 - 00701 for reporting.
 
Event Description
Upon receipt of additional information, it has been determined that this device was reported for an incorrect manufacturing site mfr.The initial report was forwarded in error and should be voided.Please see 0001822565 - 2020 - 00701 for reporting.
 
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Brand Name
TM REVERSE BASE PLATE
Type of Device
PROSTHESIS, SHOULDER
Manufacturer (Section D)
ZIMMER TMT
10 pomeroy road
parsippany NJ 07054
MDR Report Key9214919
MDR Text Key163058322
Report Number3005751028-2019-00035
Device Sequence Number1
Product Code KWT
Combination Product (y/n)N
PMA/PMN Number
K121543
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type distributor,foreign,health pr
Type of Report Initial,Followup,Followup
Report Date 02/25/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received10/21/2019
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model NumberN/A
Device Catalogue Number00434903811
Device Lot Number63122393
Was Device Available for Evaluation? No
Was the Report Sent to FDA? No
Date Manufacturer Received02/24/2020
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Hospitalization; Required Intervention;
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