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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ZIMMER BIOMET, INC. ARTICULAR SURFACE FIXED BEARING CPS RIGHT 10 MM PROSTHESIS, KNEE

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ZIMMER BIOMET, INC. ARTICULAR SURFACE FIXED BEARING CPS RIGHT 10 MM PROSTHESIS, KNEE Back to Search Results
Model Number N/A
Device Problems Material Erosion (1214); Naturally Worn (2988)
Patient Problem No Information (3190)
Event Date 06/02/2020
Event Type  Injury  
Manufacturer Narrative

(b)(4). Multiple mdr reports were filed for this event, please see associated reports: 0001822565-2020-02324, 0001822565-2020-02325, and 0001822565-2020-02327. Concomitant medical devices: unknown persona femoral, catalog#: ni, lot#: ni. Unknown persona tibial tray, catalog#: ni, lot#: ni. Unknown stryker cement, catalog#: ni, lot#: ni. Customer has indicated that the product will not be returned to zimmer biomet for investigation, as it has been discarded. The investigation is in process. Once the investigation has been completed, a follow-up mdr will be submitted.

 
Event Description

It was reported that patient underwent a right knee revision procedure due to loosening and poly wear. The cement had de-bonded from the femoral and tibial tray. Attempts have been made and no further information has been provided.

 
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Brand NameARTICULAR SURFACE FIXED BEARING CPS RIGHT 10 MM
Type of DevicePROSTHESIS, 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 Key10218143
MDR Text Key197138103
Report Number0001822565-2020-02324
Device Sequence Number1
Product Code MBH
Combination Product (Y/N)N
Reporter Country CodeUS
PMA/PMN NumberK123459
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 07/29/2020
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received07/01/2020
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device EXPIRATION Date02/28/2018
Device MODEL NumberN/A
Device Catalogue Number42522601010
Device LOT Number62276807
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA? No
Event Location No Information
Date Manufacturer Received07/28/2020
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured02/28/2013
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

Patient TREATMENT DATA
Date Received: 07/01/2020 Patient Sequence Number: 1
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