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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ZIMMER BIOMET, INC. TPRLC XR T1 PPS 14X148MM MM T1; PROSTHESIS, HIP
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ZIMMER BIOMET, INC. TPRLC XR T1 PPS 14X148MM MM T1; PROSTHESIS, HIP Back to Search Results
Model Number N/A
Device Problem Tear, Rip or Hole in Device Packaging (2385)
Patient Problem No Patient Involvement (2645)
Event Date 11/22/2019
Event Type  malfunction  
Manufacturer Narrative
(b)(4).(b)(6).Product has been received by zimmer biomet and the investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.
 
Event Description
It was reported the sterile packaging was damaged.No adverse events have been reported as a result of the malfunction.Attempts have been made and additional information on the reported event is unavailable.
 
Manufacturer Narrative
Upon reassessment of the reported event, it was determined to be not reportable.The initial report was forwarded in error and should be voided.
 
Event Description
Upon reassessment of the reported event, it was determined to be not reportable.The initial report was forwarded in error and should be voided.
 
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Brand Name
TPRLC XR T1 PPS 14X148MM MM T1
Type of Device
PROSTHESIS, HIP
Manufacturer (Section D)
ZIMMER BIOMET, INC.
56 e. bell drive
warsaw IN 46582
MDR Report Key9488514
MDR Text Key189332493
Report Number0001825034-2019-05637
Device Sequence Number1
Product Code LPH
Combination Product (y/n)N
PMA/PMN Number
K120030
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type distributor
Type of Report Initial,Followup
Report Date 04/15/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model NumberN/A
Device Catalogue Number51-105140
Device Lot Number6114622
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer12/13/2019
Was the Report Sent to FDA? No
Initial Date Manufacturer Received 11/22/2019
Initial Date FDA Received12/18/2019
Supplement Dates Manufacturer Received04/14/2020
Supplement Dates FDA Received04/15/2020
Is This a Reprocessed and Reused Single-Use Device? No
Removal/Correction NumberN/A
Patient Sequence Number1
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