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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ZIMMER BIOMET, INC. TPRLC 133 MP T1 PPS SO 8X101MM; PROSTHESIS, HIP

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ZIMMER BIOMET, INC. TPRLC 133 MP T1 PPS SO 8X101MM; PROSTHESIS, HIP Back to Search Results
Model Number N/A
Device Problem Tear, Rip or Hole in Device Packaging (2385)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 03/14/2022
Event Type  malfunction  
Event Description
It was reported upon inspection of items in stock, the packages sterility was damaged.Attempts have been made and additional information on the reported event is unavailable at this time.
 
Manufacturer Narrative
(b)(4).Report source: (b)(6).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.
 
Manufacturer Narrative
This follow-up report is being submitted to relay additional information.The following sections were updated/corrected updated: d9; g3; h2; h3; h4; h6 reported event has been confirmed.Visual evaluation of the returned product identified damage to the sterile packaging (blister).Sterility has not been compromised.Review of the device history records identified no deviations or anomalies during manufacturing related to the reported event.The likely condition of the product when it left zimmer biomet was conforming to specification.The root cause of the reported event for blister damage can be attributed to transit damage, and a packaging design issue.Upon further investigation, it has been determined that the packaging meets the acceptable criteria specifications and the sterility has not been breached.This event is no longer considered reportable.Therefore, the initial report should be voided.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 additional information on the reported event.
 
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Brand Name
TPRLC 133 MP T1 PPS SO 8X101MM
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 Key14040262
MDR Text Key288773882
Report Number0001825034-2022-00833
Device Sequence Number1
Product Code KWA
UDI-Device Identifier00880304513314
UDI-Public(01)00880304513314(17)290906(10)6623680
Combination Product (y/n)N
Reporter Country CodeJA
PMA/PMN Number
K110400
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Foreign,Company Representative,Distributor
Reporter Occupation Non-Healthcare Professional
Type of Report Initial,Followup
Report Date 05/16/2022
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 Number51-108080
Device Lot Number6623680
Was Device Available for Evaluation? Device Returned to Manufacturer
Was the Report Sent to FDA? No
Initial Date Manufacturer Received 03/14/2022
Initial Date FDA Received04/07/2022
Supplement Dates Manufacturer Received05/11/2022
Supplement Dates FDA Received05/17/2022
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured09/06/2019
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Removal/Correction NumberNI
Patient Sequence Number1
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