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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ZIMMER BIOMET, INC. TPRLC XR MP T1 PPS 17X119MM; PROSTHESIS, HIP
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ZIMMER BIOMET, INC. TPRLC XR MP T1 PPS 17X119MM; PROSTHESIS, HIP Back to Search Results
Model Number N/A
Device Problem Device Packaging Compromised (2916)
Patient Problem No Patient Involvement (2645)
Event Date 05/02/2018
Event Type  malfunction  
Manufacturer Narrative
(b)(4).(b)(6).Customer has indicated that the product will not be returned to zimmer biomet for investigation.The investigation is in process.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 - 2018 - 03605, 0001825034 - 2018 - 03606, 0001825034 - 2018 - 03607, 0001825034 - 2018 - 03608, 0001825034 - 2018 - 03609, 0001825034 - 2018 - 03610, 0001825034 - 2018 - 03611, 0001825034 - 2018 - 03612, 0001825034 - 2018 - 03613, 0001825034 - 2018 - 03614, 0001825034 - 2018 - 03615, 0001825034 - 2018 - 03616, 0001825034 - 2018 - 03617, 0001825034 - 2018 - 03618, 0001825034 - 2018 - 03619, 0001825034 - 2018 - 03620, 0001825034 - 2018 - 03621, 0001825034 - 2018 - 03622, 0001825034 - 2018 - 03624, 0001825034 - 2018 - 03625, 0001825034 - 2018 - 03626, 0001825034 - 2018 - 03627.
 
Event Description
It was reported that debris was found in the sterile package.Attempts have been made and additional information on the reported event is unavailable.
 
Event Description
No further event information available at the time of this report.
 
Manufacturer Narrative
Complaint sample was evaluated and the reported event was confirmed.Visual inspection of the returned box revealed that debris was present in the blister.The sterile seal on the box were intact when received.Dhr was reviewed and no discrepancies relevant to the reported event were found.The reported event occurred during the manufacturing 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.
 
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Brand Name
TPRLC XR MP T1 PPS 17X119MM
Type of Device
PROSTHESIS, HIP
Manufacturer (Section D)
ZIMMER BIOMET, INC.
56 e. bell drive
warsaw IN 46582
MDR Report Key7557406
MDR Text Key109761738
Report Number0001825034-2018-03623
Device Sequence Number1
Product Code LPH
Combination Product (y/n)N
PMA/PMN Number
PK120030
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type distributor,foreign,health pr
Type of Report Initial,Followup
Report Date 01/11/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received05/31/2018
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Physician
Device Model NumberN/A
Device Catalogue Number51-145170
Device Lot Number6165957
Other Device ID Number(01) 00880304517363
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer07/05/2018
Was the Report Sent to FDA? No
Date Manufacturer Received12/19/2018
Is This a Reprocessed and Reused Single-Use Device? No
Removal/Correction NumberN/A
Patient Sequence Number1
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