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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 06/22/2020
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. Multiple mdr reports were filed for this event, please see associated reports: 0001825034-2020-02741, 0001825034-2020-02742, 0001825034-2020-02744, 0001825034-2020-02745, 0001825034-2020-02747.
 
Event Description
It was reported that during warehouse stock investigation, debris is noted 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.
 
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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 Key10269718
MDR Text Key198863577
Report Number0001825034-2020-02746
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 09/29/2020
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received07/14/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberN/A
Device Catalogue Number51-103170
Device Lot Number3469258
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer07/24/2020
Is the Reporter a Health Professional?
Was the Report Sent to FDA? No
Event Location No Information
Date Manufacturer Received09/28/2020
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured11/26/2014
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Invalid Data
Removal/Correction NumberN/A

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