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U.S. Department of Health and Human Services

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

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ZIMMER BIOMET, INC. TAPERLOC STEM 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 06/02/2020
Event Type  malfunction  
Manufacturer Narrative
(b)(4). Report source: (b)(6). Product is in process of being returned to zimmer biomet for the investigation and a follow-up mdr will be submitted upon completion.
 
Event Description
It was reported that during stock investigation, debris was found in the sterile packaging. There was no patient involvement. Attempts have been made and additional information on the reported event is unavailable at this time.
 
Manufacturer Narrative
Complaint sample was returned and evaluated against the reported event. Evaluation of the returned product/photographs provided confirmed foreign debris is present inside the sterile packaging, and the sterile packaging remains sealed. Dhr was reviewed and no discrepancies were found. The likely condition of the device when it left zimmer biomet is non-conforming to specification. The root cause of the reported event is the operator not following the work instructions provided. 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 additional event information to report at this time.
 
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Brand NameTAPERLOC 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 Key10195303
MDR Text Key199549361
Report Number0001825034-2020-02496
Device Sequence Number1
Product Code KWA
Combination Product (y/n)N
Reporter Country CodeJA
PMA/PMN Number
K101086
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Reporter Occupation Non-Healthcare Professional
Type of Report Initial,Followup
Report Date 09/25/2020
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received06/25/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberN/A
Device Catalogue Number51-101070
Device Lot Number6763008
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer06/29/2020
Is the Reporter a Health Professional?
Was the Report Sent to FDA? No
Event Location No Information
Date Manufacturer Received09/24/2020
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured03/17/2020
Is the Device Single Use? No Answer Provided
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Invalid Data
Removal/Correction NumberN/A

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