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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ZIMMER BIOMET, INC. PERSONA FEMORAL CR IMPACTOR PAD INSTRUMENT, KNEE

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ZIMMER BIOMET, INC. PERSONA FEMORAL CR IMPACTOR PAD INSTRUMENT, KNEE Back to Search Results
Model Number N/A
Device Problems Fracture (1260); No Apparent Adverse Event (3189)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 07/03/2018
Event Type  Malfunction  
Manufacturer Narrative

(b)(4). The product has been received by zimmer biomet and the investigation is in process. Once the investigation has been completed, a follow-up mdr will be submitted.

 
Event Description

It is reported that the impactor pad fractured upon impaction during right knee arthroplasty. No adverse events were reported as a result of this event.

 
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Brand NamePERSONA FEMORAL CR IMPACTOR PAD
Type of DeviceINSTRUMENT, KNEE
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 Key7771883
MDR Text Key116717400
Report Number0001822565-2018-04291
Device Sequence Number1
Product Code MBH
Combination Product (Y/N)N
Reporter Country CodeUS
PMA/PMN NumberPK172524
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type DISTRIBUTOR,HEALTH PROFESSION
Reporter Occupation
Type of Report Initial,Followup
Report Date 10/04/2018
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received08/10/2018
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device MODEL NumberN/A
Device Catalogue Number42509909400
Device LOT Number62305405
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer07/20/2018
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received09/20/2018
Was Device Evaluated By Manufacturer? Yes
Date Device Manufactured03/15/2013
Is The Device Single Use? No
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse
Removal/Correction NumberN/A

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