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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ZIMMER BIOMET, INC. TPRLC 133 T1 PPS SO 15X150MM T1; PROSTHESIS, HIP

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ZIMMER BIOMET, INC. TPRLC 133 T1 PPS SO 15X150MM T1; PROSTHESIS, HIP Back to Search Results
Model Number N/A
Device Problem Packaging Problem (3007)
Patient Problem No Patient Involvement (2645)
Event Date 11/20/2019
Event Type  malfunction  
Manufacturer Narrative
(b)(4).(b)(6).Visual inspection of the returned product found the blister seal to be intact.The foam inserts have been damaged such that foam debris are present within the blister.Visual inspection confirmed that the inner pouch containing the stem is torn such that the inner sterile barrier is compromised.Complaint sample was evaluated and the reported event was confirmed.Device history record was reviewed and no discrepancies were found.The likely condition of the part when it left zimmer biomet control is considered conforming based on the evaluation of the returned product, the dhr review, and the potential transit age of the device.The root cause for the presence of foam debris within the sterile cavity as well as the damaged inner pouch is attributed to damage during transit.This device falls within the scope of a corrective action which is to assess all current sterile barrier systems used to package products at zimmer biomet bridgend.As part of this corrective action, the pouch is being improved to use a stronger material (nylon), and foam end caps are being added.Also, the orientation the devices are packed in the shipper box is moving from vertical to horizontal, and the thickness of the shipper box has been increased.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
It was reported that the sterile package was damaged and the sterility of the device has been compromised.Additional information on the reported event is unavailable.
 
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Brand Name
TPRLC 133 T1 PPS SO 15X150MM T1
Type of Device
PROSTHESIS, HIP
Manufacturer (Section D)
ZIMMER BIOMET, INC.
56 e. bell drive
warsaw IN 46582
Manufacturer (Section G)
ZIMMER BIOMET, INC.
56 e. bell drive
warsaw IN 46582
Manufacturer Contact
christina arnt
56 e. bell dr.
warsaw, IN 46582
5745273773
MDR Report Key9952854
MDR Text Key187876488
Report Number0001825034-2020-01595
Device Sequence Number1
Product Code KWA
UDI-Device Identifier00880304491861
UDI-Public(01)00880304491861(17)270420(10)6032512
Combination Product (y/n)N
Reporter Country CodeJA
PMA/PMN Number
K103755
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,distri
Reporter Occupation Non-Healthcare Professional
Type of Report Initial
Report Date 04/10/2020
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 Number51-103150
Device Lot Number6032512
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer12/16/2019
Was the Report Sent to FDA? No
Initial Date Manufacturer Received 11/20/2019
Initial Date FDA Received04/13/2020
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured04/20/2017
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 Sequence Number1
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