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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ZIMMER BIOMET, INC. TPRLC 133 T1 PPS SO 18X156MM; HIP PROSTHESIS
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ZIMMER BIOMET, INC. TPRLC 133 T1 PPS SO 18X156MM; HIP PROSTHESIS Back to Search Results
Model Number N/A
Device Problem Shipping Damage or Problem (1570)
Patient Problem No Patient Involvement (2645)
Event Date 01/31/2019
Event Type  malfunction  
Manufacturer Narrative
(b)(4).Customer has indicated that the product is in process of being returned to zimmer biomet for investigation.Once the investigation has been completed, a follow-up mdr will be submitted.Foreign source - (b)(6).
 
Event Description
It was reported that the incoming inspection member found the sterile package was deformed due to impact of the inner stem during distribution.Attempts have been made and no further information has been provided.
 
Manufacturer Narrative
Upon inspecting the returned device, it was determined to be not reportable as the package was damaged but sterility was not compromised.
 
Event Description
Upon inspecting the returned device, it was determined to be not reportable as the package was damaged but sterility was not compromised.
 
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Brand Name
TPRLC 133 T1 PPS SO 18X156MM
Type of Device
HIP PROSTHESIS
Manufacturer (Section D)
ZIMMER BIOMET, INC.
56 e. bell drive
warsaw IN 46582
MDR Report Key8353210
MDR Text Key137266474
Report Number0001825034-2019-00692
Device Sequence Number1
Product Code KWA
Combination Product (y/n)N
PMA/PMN Number
K101086
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Type of Report Initial,Followup
Report Date 07/25/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received02/20/2019
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model NumberN/A
Device Catalogue Number51-103180
Device Lot Number2525434
Was Device Available for Evaluation? Yes
Was the Report Sent to FDA? No
Date Manufacturer Received07/18/2019
Is This a Reprocessed and Reused Single-Use Device? No
Removal/Correction NumberN/A
Patient Sequence Number1
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