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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ZIMMER BIOMET, INC. TPRLC 133 MP T1 PPS SO 8X101MM PROSTHESIS, HIP

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ZIMMER BIOMET, INC. TPRLC 133 MP T1 PPS SO 8X101MM 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). Report source: foreign: country: (b)(6). 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. Multiple mdr reports were filed for this event, please see associated reports: 0001825034-2020-02342, 0001825034-2020-02343, 0001825034-2020-02344, 0001825034-2020-02345, 0001825034-2020-02346, 0001825034-2020-02347.
 
Event Description
It was reported upon inspection at the incoming warehouse, there was debris in the sterile package. No patient involvement. No additional information is available.
 
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Brand NameTPRLC 133 MP T1 PPS SO 8X101MM
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 Key10201136
MDR Text Key199637678
Report Number0001825034-2020-02348
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,foreig
Reporter Occupation Non-Healthcare Professional
Type of Report Initial,Followup
Report Date 07/16/2020
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received06/26/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberN/A
Device Catalogue Number51-108080
Device Lot Number6773340
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer06/26/2020
Is the Reporter a Health Professional?
Was the Report Sent to FDA? No
Event Location No Information
Date Manufacturer Received07/13/2020
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured03/31/2020
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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