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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ZIMMER BIOMET, INC. TPRLC 133 T1 PPS HO 17X154MM 4MM T1; PROSTHESIS, HIP
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ZIMMER BIOMET, INC. TPRLC 133 T1 PPS HO 17X154MM 4MM T1; PROSTHESIS, HIP Back to Search Results
Model Number N/A
Device Problem Packaging Problem (3007)
Patient Problem No Patient Involvement (2645)
Event Date 12/24/2019
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.
 
Event Description
It was reported that there was debris in the sterile package.Additional information on the reported event is unavailable.
 
Event Description
Upon receipt of additional information, it has been determined that this device did not cause or contribute to the reported event.The initial report was forwarded in error and should be voided.
 
Manufacturer Narrative
Upon receipt of additional information, it has been determined that this device did not cause or contribute to the reported event.The initial report was forwarded in error and should be voided.
 
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Brand Name
TPRLC 133 T1 PPS HO 17X154MM 4MM T1
Type of Device
PROSTHESIS, HIP
Manufacturer (Section D)
ZIMMER BIOMET, INC.
56 e. bell drive
warsaw IN 46582
MDR Report Key9586508
MDR Text Key194999723
Report Number0001825034-2020-00239
Device Sequence Number1
Product Code JDI
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,distri
Type of Report Initial,Followup
Report Date 04/17/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received01/14/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model NumberN/A
Device Catalogue Number51-104170
Device Lot Number6052093
Was Device Available for Evaluation? No
Was the Report Sent to FDA? No
Date Manufacturer Received04/15/2020
Is This a Reprocessed and Reused Single-Use Device? No
Removal/Correction NumberN/A
Patient Sequence Number1
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