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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ZIMMER BIOMET, INC. TPRLC XR MP T1 PPS 15X115MM 115MM T1; PROSTHESIS, HIP
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ZIMMER BIOMET, INC. TPRLC XR MP T1 PPS 15X115MM 115MM T1; PROSTHESIS, HIP Back to Search Results
Catalog Number 51-145150
Device Problem Device Contaminated During Manufacture or Shipping (2969)
Patient Problem No Patient Involvement (2645)
Event Date 02/07/2020
Event Type  malfunction  
Manufacturer Narrative
(b)(4).Udi#: (b)(4).Concomitant medical products: tprlc 133 mp type1 pps ho 16.0 m t1, cat# 51-107160, lot# 6156230.Tprlc xr mp t1 pps 17x119mm 119mm t1, cat# 51-145170, lot# 2898306.Tprlc 133 t1 pps ho 15x150mm 0mm t1, cat# 51-104150, lot# 3838102.Tprlc xr mp t1 pps 16x117mm 117mm t1, cat# 51-145160, lot# 3791241.Tprlc xr mp t1 pps 15x115mm 115mm t1, cat# 51-145150, lot# 3756093.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.Multiple mdr reports were filed for this event, please see associated reports: 0001825034-2020-00856, 0001825034-2020-00857, 0001825034-2020-00858, 0001825034-2020-00860, 0001825034-2020-00861.
 
Event Description
It was reported that debris was found within sterile packages while investigating circulated items.No hospitals were involved.Attempts have been made and additional information on the reported event is unavailable at this time.
 
Manufacturer Narrative
This follow-up report is being submitted to relay additional information.Evaluation of the returned product confirmed there is debris inside the sterile packaging which is consistent with the appearance of foam debris from the foam packaging inside the sterile barrier and porous particular from the implant.Sterility of the product is intact and reported event is confirmed.Review of the device history records identified no deviations or anomalies during manufacturing related to the reported event.Root cause was unable to be determined as the necessary information to adequately investigate the reported event was not provided.The event is being addressed through the capa process.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 further event information is available at the time of this report.
 
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Brand Name
TPRLC XR MP T1 PPS 15X115MM 115MM T1
Type of Device
PROSTHESIS, HIP
Manufacturer (Section D)
ZIMMER BIOMET, INC.
56 e. bell drive
warsaw IN 46582
MDR Report Key9749679
MDR Text Key203844246
Report Number0001825034-2020-00859
Device Sequence Number1
Product Code OQG
Combination Product (y/n)N
PMA/PMN Number
K120030
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Type of Report Initial,Followup
Report Date 04/14/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received02/25/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Catalogue Number51-145150
Device Lot Number3739732
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer03/13/2020
Was the Report Sent to FDA? No
Date Manufacturer Received04/09/2020
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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