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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ZIMMER BIOMET, INC. ARTICULAR SURFACE FIXED BEARING POSTERIOR STABILIZED KNEE, PROSTHESIS

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ZIMMER BIOMET, INC. ARTICULAR SURFACE FIXED BEARING POSTERIOR STABILIZED KNEE, PROSTHESIS Back to Search Results
Catalog Number 42512400510
Device Problem Material Erosion (1214)
Patient Problems Pain (1994); Synovitis (2094)
Event Date 06/22/2018
Event Type  Injury  
Manufacturer Narrative

(b)(4). Multiple mdr reports were filed for this event, please see associated reports: 3007963827-2018-00117, 0001822565-2018-03847, 0001822565-2018-03849. Concomitant medical products: femur cemented posterior stabilized cat: 42500006201 lot: 62366970 tibia cemented 5 degree stemmed cat: 42532006701 lot: 62851833. 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

It was reported that a patient underwent an initial knee procedure. Subsequently, the patient was revised due to pain, loosening of the femoral and tibial components, and synovitis noted during the procedure along with poly wear of the post. The articular surface was found to have gouges on the post.

 
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Brand NameARTICULAR SURFACE FIXED BEARING POSTERIOR STABILIZED
Type of DeviceKNEE, PROSTHESIS
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 Key7751251
MDR Text Key116045048
Report Number0001822565-2018-03847
Device Sequence Number1
Product Code MBH
Combination Product (Y/N)N
Reporter Country CodeUS
PMA/PMN NumberPK121771
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type COMPANY REPRESENTATIVE,HEALTH
Reporter Occupation
Type of Report Initial,Followup
Report Date 05/15/2019
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received08/06/2018
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device EXPIRATION Date07/31/2019
Device Catalogue Number42512400510
Device LOT Number62775443
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer07/12/2018
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA? No
Event Location No Information
Date Manufacturer Received05/09/2019
Was Device Evaluated By Manufacturer? Yes
Date Device Manufactured08/14/2014
Is The Device Single Use? Yes
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Patient TREATMENT DATA
Date Received: 08/06/2018 Patient Sequence Number: 1
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