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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ZIMMER BIOMET, INC. TPRLC 133 T1 PPS SO 10X140MM T1; PROSTHESIS, HIP

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ZIMMER BIOMET, INC. TPRLC 133 T1 PPS SO 10X140MM T1; PROSTHESIS, HIP Back to Search Results
Model Number N/A
Device Problem Device Contaminated During Manufacture or Shipping (2969)
Patient Problem No Patient Involvement (2645)
Event Date 10/13/2020
Event Type  malfunction  
Manufacturer Narrative
(b)(4).Foreign report source: (b)(6).Multiple mdr reports were filed for this event, please see associated reports: 0001825034 - 2020 - 03889.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 by the distributorship that the products were found to be nonconforming.The incoming inspection team member found debris in the sterile package.No additional information is available.
 
Event Description
No further event information available at the time of this report.
 
Manufacturer Narrative
(b)(4).Complaint sample was evaluated and the reported event was confirmed.Device history record (dhr) was reviewed and no discrepancies related to the event were found.The root cause of the reported event is the operator not following the work instructions provided.Evaluation of the returned product/photographs provided confirmed foreign debris is present inside the sterile packaging, and the sterile packaging remains sealed.The reported event is confirmed.Sterility has been breached.The likely condition of the device when it left zimmer biomet is non-conforming to specification.If any further information is found which would change or alter any conclusions or information, a supplemental report will be filed accordingly.Zimmer biomet will continue to monitor for trends.
 
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Brand Name
TPRLC 133 T1 PPS SO 10X140MM T1
Type of Device
PROSTHESIS, HIP
Manufacturer (Section D)
ZIMMER BIOMET, INC.
56 e. bell drive
warsaw IN 46582
MDR Report Key10733633
MDR Text Key213002244
Report Number0001825034-2020-03890
Device Sequence Number1
Product Code KWA
UDI-Device Identifier00880304489684
UDI-Public00880304489684
Combination Product (y/n)N
PMA/PMN Number
K101086
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type distributor,foreign
Type of Report Initial,Followup
Report Date 01/07/2021
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 Number51-103100
Device Lot Number6795313
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer10/30/2020
Was the Report Sent to FDA? No
Initial Date Manufacturer Received 10/13/2020
Initial Date FDA Received10/26/2020
Supplement Dates Manufacturer Received01/07/2021
Supplement Dates FDA Received01/07/2021
Is This a Reprocessed and Reused Single-Use Device? No
Removal/Correction NumberN/A
Patient Sequence Number1
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