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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ZIMMER BIOMET, INC. TAPERLOC 133 MP T1 PPS SO 5X95MM PROSTHESIS, HIP

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ZIMMER BIOMET, INC. TAPERLOC 133 MP T1 PPS SO 5X95MM 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 06/03/2020
Event Type  malfunction  
Manufacturer Narrative
(b)(4). Foreign report source: (b)(6). Multiple mdr reports were filed for this event, please see associated reports: 0001825034-2020-02273, 0001825034-2020-02274, 0001825034-2020-02275, 0001825034-2020-02276, 0001825034-2020-02277, 0001825034-2020-02278. Customer has indicated that the product is in process of being returned to zimmer biomet for investigation. Once the investigation has been completed, a follow-up mdr will be submitted.
 
Event Description
It was reported that there was debris in the sterile package. No adverse events have been reported as a result of the malfunction and additional information on the reported event is unavailable.
 
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Brand NameTAPERLOC 133 MP T1 PPS SO 5X95MM
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 Key10135572
MDR Text Key194674487
Report Number0001825034-2020-02273
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 company representative,distri
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 Received06/09/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberN/A
Device Catalogue Number51-108050
Device Lot Number3825959
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer06/30/2020
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 Manufactured07/06/2016
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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