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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ZIMMER BIOMET, INC. UNKNOWN FINN TIBIAL TRAY PROSTHESIS KNEE

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ZIMMER BIOMET, INC. UNKNOWN FINN TIBIAL TRAY PROSTHESIS KNEE Back to Search Results
Model Number N/A
Device Problems Unstable (1667); Osseointegration Problem (3003)
Patient Problems Osteolysis (2377); Patient Problem/Medical Problem (2688)
Event Date 06/14/2018
Event Type  Injury  
Manufacturer Narrative
(b)(4). Concomitant products - catalog #: unknown, unknown finn bearing, lot # unknown; catalog #: unknown, unknown finn stem, lot # unknown. Reported event was unable to be confirmed due to limited information received from the customer. The device history record was unable to be reviewed due to no lot or item number being provided root cause was unable to be determined as the necessary information to adequately investigate the reported event was not provided. External radiologist reviewed provided x-rays and noted that there is extensive osteolysis and abnormal lucency along the tibial component and stem component shows valgus angulation. 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 multiple mdr reports were filed for this event, please see associated reports: 0001825034-2018-04473, 0001822565-2018-03966. Remains implanted.
 
Event Description
It was reported that the patient required a knee revision of the bearing and polyethylened hinge components approximately 18 years post implantation due to wear. It was also reported the patient was experiencing instability.
 
Manufacturer Narrative
(b)(4). There was no wear. 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.
 
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Brand NameUNKNOWN FINN TIBIAL TRAY
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 Key7759777
MDR Text Key116363077
Report Number0001822565-2018-03964
Device Sequence Number1
Product Code KRO
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
PNI
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative
Reporter Occupation
Type of Report Initial,Followup
Report Date 08/22/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received08/07/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberN/A
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received08/15/2018
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
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: 08/07/2018 Patient Sequence Number: 1
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