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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ZIMMER BIOMET, INC. TAPERLOC FEMORAL STEM PROSTHESIS, HIP

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ZIMMER BIOMET, INC. TAPERLOC FEMORAL 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 03/03/2020
Event Type  malfunction  
Manufacturer Narrative
(b)(4). Report source (b)(6). Complaint sample was returned and reviewed against the reported event. Six boxes were returned and evaluated, noting the sterile barrier has been broken on three of the boxes. The other three remain intact. Dhr was reviewed and no discrepancies were found. The likely condition of the device when it left zimmer biomet is conforming to specification. The investigation has concluded that the root cause of the reported event is likely to be damage during transit. Multiple mdr reports were filed for this event, please see associated reports: 0001825034-2020-01299, 0001825034-2020-01300.
 
Event Description
It was reported that during stock investigation, it was found that the sterile packages were damaged. There was no patient involvement. Attempts have been made and additional information on the reported event is unavailable at this time.
 
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Brand NameTAPERLOC FEMORAL STEM
Type of DevicePROSTHESIS, 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 Key10314423
MDR Text Key200430878
Report Number0001825034-2020-01297
Device Sequence Number1
Product Code KWA
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 distributor,foreign
Reporter Occupation Non-Healthcare Professional
Type of Report Initial
Report Date 07/23/2020
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received07/23/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date02/28/2022
Device Model NumberN/A
Device Catalogue Number51-107140
Device Lot Number2569178
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer05/11/2020
Is the Reporter a Health Professional?
Was the Report Sent to FDA? No
Event Location No Information
Date Manufacturer Received07/21/2020
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured02/01/2012
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Removal/Correction NumberN/A

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