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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 12 MM HEIGHT PROSTHESIS, KNEE

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ZIMMER BIOMET, INC. ARTICULAR SURFACE FIXED BEARING CPS RIGHT 12 MM HEIGHT PROSTHESIS, KNEE Back to Search Results
Model Number N/A
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Infiltration into Tissue (1931); Nerve Damage (1979); Pain (1994); Numbness (2415); Ambulation Difficulties (2544)
Event Date 10/30/2017
Event Type  Injury  
Manufacturer Narrative

(b)(4). Multiple mdr reports were filed for this event, please see associated reports: 0001822565-2019-02857, 0001822565-2019-02858, and 0001822565-2019-02859. Concomitant medical products: unknown zimmer ps femoral catalog#: ni lot#: ni, unknown zimmer ps tibial tray catalog#: ni lot#: ni. Customer has indicated that the product will not be returned to zimmer biomet for investigation, as it remains implanted. 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 right total knee arthroplasty. The surgeon expected to do a cruciate retaining knee, but realized that he would instead need to do a posterior stabilized knee. A posterior stabilized knee kit was not available nearby, so the patient was kept under anesthesia for twelve (12) hours while a posterior stabilized kit was retrieved. Patient is now reporting pain, difficulty walking, and nerve damage. No revision procedure has been reported at this time.

 
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Brand NameARTICULAR SURFACE FIXED BEARING CPS RIGHT 12 MM HEIGHT
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 Key8767129
MDR Text Key150250877
Report Number0001822565-2019-02858
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 CONSUMER,OTHER
Reporter Occupation
Type of Report Initial,Followup,Followup
Report Date 12/05/2019
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received07/08/2019
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator HEALTH PROFESSIONAL
Device MODEL NumberN/A
Device Catalogue Number42522600812
Device LOT Number63435556
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 Received12/04/2019
Was Device Evaluated By Manufacturer? Yes
Date Device Manufactured08/16/2016
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: 07/08/2019 Patient Sequence Number: 1
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