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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ZIMMER BIOMET, INC. ARTICULAR SURFACE FIXED BEARING CRUCIATE RETAINING (CR) LEFT 11 MM HEIGHT KNEE, PROSTHESIS

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ZIMMER BIOMET, INC. ARTICULAR SURFACE FIXED BEARING CRUCIATE RETAINING (CR) LEFT 11 MM HEIGHT KNEE, PROSTHESIS Back to Search Results
Catalog Number 42512000511
Device Problems Difficult to Insert (1316); Unstable (1667); Insufficient Information (3190); Migration (4003)
Patient Problem No Information (3190)
Event Date 05/15/2018
Event Type  Injury  
Manufacturer Narrative
(b)(4). All poly patella cat: 42540000032 lot: 62405046; trabecular metal femoral cruciate retaining cat: 42502806801 lot: 62614832; natural tibia trabecular metal fixed bearing 42530007501 lot: 62657581. It is unknown if product will be returning to zimmer biomet and the investigation is in process. Once the investigation has been completed, a follow-up mdr will be submitted. 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. Product not returned.
 
Event Description
It was reported that the patient was revised due to unknown reasons. Only the articular surface was revised.
 
Manufacturer Narrative
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 the patient was revised due to instability, laxity and loosening, only the articular surface was revised. It was further reported that the surgeon had difficulty inserting the articular surface.
 
Manufacturer Narrative
Reported event was confirmed by review of op notes provided. Medical records indicate evidence of loosening, laxity, and instability. Further noted was mild synovitis and the poly was increased by two sizes. Finally, it was noted that the was difficulty initially with the flanges capturing posteriorly and eventually got it to lock in appropriately. Device history record was reviewed and no discrepancies were found. Root cause was unable to be determined. 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
No further event information available at the time of this report.
 
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Brand NameARTICULAR SURFACE FIXED BEARING CRUCIATE RETAINING (CR) LEFT 11 MM HEIGHT
Type of DeviceKNEE, PROSTHESIS
Manufacturer (Section D)
ZIMMER BIOMET, INC.
56 e. bell drive
warsaw IN 46582
MDR Report Key7659879
MDR Text Key113065786
Report Number0001822565-2018-03581
Device Sequence Number1
Product Code OIY
Combination Product (y/n)N
PMA/PMN Number
PK121771
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Type of Report Initial,Followup,Followup
Report Date 04/04/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received07/03/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date09/30/2018
Device Catalogue Number42512000511
Device Lot Number62500748
Was Device Available for Evaluation? No
Was the Report Sent to FDA? No
Event Location No Information
Date Manufacturer Received04/01/2019
Is This a Reprocessed and Reused Single-Use Device? No

Patient Treatment Data
Date Received: 07/03/2018 Patient Sequence Number: 1
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