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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ZIMMER BIOMET, INC. FINN ROTATING HINGED KNEE MODULAR TIBIAL BEARING 12MM PROSTHESIS, KNEE

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ZIMMER BIOMET, INC. FINN ROTATING HINGED KNEE MODULAR TIBIAL BEARING 12MM PROSTHESIS, KNEE Back to Search Results
Model Number N/A
Device Problem Naturally Worn (2988)
Patient Problem No Code Available (3191)
Event Date 01/22/2019
Event Type  Injury  
Manufacturer Narrative
(b)(4). Implant date - the product was implanted on an unknown date in 1996. Concomitant medical products- unknown orthopedic salvage system femoral component catalog #: ni lot #: ni, unknown orthopedic salvage system tibial component catalog #: ni lot #: ni. The complainant has indicated that the product will not be returned to zimmer biomet for investigation, as the hospital would not release the product. The investigation is in process. Once the investigation has been completed, a follow-up mdr will be submitted. Investigation incomplete.
 
Event Description
It is reported that the patient underwent a knee arthroplasty revision to exchange the polyethylene bearing to address wear approximately twenty (20) years post-operatively. No additional patient consequences were reported.
 
Event Description
No further event information available at the time of this report.
 
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Brand NameFINN ROTATING HINGED KNEE MODULAR TIBIAL BEARING 12MM
Type of DevicePROSTHESIS, KNEE
Manufacturer (Section D)
ZIMMER BIOMET, INC.
56 e. bell drive
warsaw IN 46582
MDR Report Key8317415
MDR Text Key135429101
Report Number0001825034-2019-00459
Device Sequence Number1
Product Code KRO
Combination Product (y/n)N
PMA/PMN Number
K945028
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type distributor,health profession
Type of Report Initial,Followup,Followup
Report Date 08/14/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received02/07/2019
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date01/28/2003
Device Model NumberN/A
Device Catalogue Number153982
Device Lot Number529940
Was Device Available for Evaluation? No
Was the Report Sent to FDA? No
Event Location No Information
Date Manufacturer Received08/12/2019
Is This a Reprocessed and Reused Single-Use Device? No
Removal/Correction NumberN/A

Patient Treatment Data
Date Received: 02/07/2019 Patient Sequence Number: 1
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