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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ZIMMER BIOMET, INC. TAPERLOC COMPLETE XR 123 MICRO FEMORAL POROUS COATED STEM; PROSTHESIS, HIP

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ZIMMER BIOMET, INC. TAPERLOC COMPLETE XR 123 MICRO FEMORAL POROUS COATED STEM; PROSTHESIS, HIP Back to Search Results
Model Number N/A
Device Problem Tear, Rip or Hole in Device Packaging (2385)
Patient Problem No Patient Involvement (2645)
Event Date 04/07/2020
Event Type  malfunction  
Manufacturer Narrative
(b)(4).(b)(6).Product is in process of being returned to zimmer biomet for the 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: 0001825034-2020-01840.
 
Event Description
It was reported that during stock investigation at the warehouse, the inner pouch was torn.There was no patient involvement.Attempts have been made and additional information on the reported event is unavailable at this time.
 
Event Description
No additional event information to report at this time.
 
Manufacturer Narrative
Complaint sample was returned and evaluated against the reported event.Evaluation of the returned products provided confirmed the sterile packaging (blister) is damaged.Dhr was reviewed and no discrepancies were found.The root cause of the reported event is likely due to damage during transit.The likely condition of the device when it left zimmer biomet is conforming to specification.The device evaluation found no malfunction and the event did not contribute to injury, therefore this would not be considered a reportable event.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
TAPERLOC COMPLETE XR 123 MICRO FEMORAL POROUS COATED STEM
Type of Device
PROSTHESIS, HIP
Manufacturer (Section D)
ZIMMER BIOMET, INC.
56 e. bell drive
warsaw IN 46582
MDR Report Key10013141
MDR Text Key189573592
Report Number0001825034-2020-01841
Device Sequence Number1
Product Code LPH
UDI-Device Identifier00880304517356
UDI-Public(01)00880304517356
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,distri
Type of Report Initial,Followup
Report Date 06/29/2020
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 Number51-145160
Device Lot Number6118753
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer05/19/2020
Was the Report Sent to FDA? No
Initial Date Manufacturer Received 04/07/2020
Initial Date FDA Received04/30/2020
Supplement Dates Manufacturer Received06/26/2020
Supplement Dates FDA Received06/29/2020
Is This a Reprocessed and Reused Single-Use Device? No
Removal/Correction NumberN/A
Patient Sequence Number1
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