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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ZIMMER BIOMET, INC. MAXIM CONSTRAINED TIBIAL BEARING; KNEE PROSTHESIS
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ZIMMER BIOMET, INC. MAXIM CONSTRAINED TIBIAL BEARING; KNEE PROSTHESIS Back to Search Results
Model Number N/A
Device Problem Detachment Of Device Component (1104)
Patient Problem Pain (1994)
Event Date 04/24/2018
Event Type  Injury  
Manufacturer Narrative
(b)(4).Concomitant medical products: maxim stemmed tibial plate catalog # 141513 lot # 239110, ti maxim 65 const rt intlk fem catalog # cp110278 lot # 367080, biomet ilok stem tib tray 71mm catalog # 141513 lot # 239110, bmt splined knee stm 14x80 catalog # 141614 lot # 384710, arcom rnglc lnr 22mm 10deg 22 catalog # 11-105842 lot # 135260.Customer has indicated that the product will not be returned because it remains implanted.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.Multiple mdr reports were filled for this event: 0001825034-2018-02796.Remains implanted.
 
Event Description
It was reported that the patient underwent a right total knee arthroplasty.Subsequently, the patient is experiencing pain and disassociation of the implant post-operative.
 
Manufacturer Narrative
(b)(4).
 
Event Description
It was reported that the patient underwent right knee arthroplasty revision due to pain and disassociation of the polyethylene bearing.Only the polyethylene bearing was removed and replaced.Attempts have been made and additional information on the reported event is unavailable.
 
Manufacturer Narrative
(b)(4).
 
Event Description
It was reported that the patient underwent right knee arthroplasty revision due to pain and disassociation of the polyethylene bearing.Only the polyethylene bearing was removed and replaced.Revision operative notes were received that indicate the patient was revised due to the screw migrating to the knuckle of the tibial polyethylene liner and irritating the other implants, resulting in metallosis.The femoral, tibial and patellar implants were well fixed and only the polyethylene articular surface and screw were removed and replaced.Attempts have been made and additional information on the reported event is unavailable.
 
Event Description
No further event information available at the time of this report.
 
Manufacturer Narrative
The complaint sample was evaluated and the reported event was confirmed through physical evaluation and review of medical records.The returned tibial bearing and femoral stem post screw showed that the post screw was embedded in the tibial bearing and the threads on the posterior side of the screw had been worn down, likely from articulation on the femur after disassociation.Black staining could be seen on the tibial bearing and the articulating surfaces showed evidence of delamination and wear.The post where the screw was embedded was severely damaged.The device history records were reviewed and no discrepancies were identified.The revision operative notes identified significant black staining of the synovial soft tissues and some of the bone with a small area of wear along the patellar component.The femoral, tibial and patellar component were all well-fixed and the screw was locked in to the post of the tibial polyethylene liner.The metallosis found in the joint was likely the result of the disassociated screw articulating with the femur in vivo.Due to the damage sustained by the screw in vivo, further analysis could not be performed.A definitive root cause cannot 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.
 
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Brand Name
MAXIM CONSTRAINED TIBIAL BEARING
Type of Device
KNEE PROSTHESIS
Manufacturer (Section D)
ZIMMER BIOMET, INC.
56 e. bell drive
warsaw IN 46582
MDR Report Key7432464
MDR Text Key105531614
Report Number0001825034-2018-02792
Device Sequence Number1
Product Code JWH
Combination Product (y/n)N
PMA/PMN Number
PK921182
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type consumer,health professional
Type of Report Initial,Followup,Followup,Followup
Report Date 12/26/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received04/16/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date01/31/2006
Device Model NumberN/A
Device Catalogue Number146760
Device Lot Number946600
Other Device ID NumberN/A
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer04/25/2018
Was the Report Sent to FDA? No
Date Manufacturer Received12/20/2018
Is This a Reprocessed and Reused Single-Use Device? No
Removal/Correction NumberN/A
Patient Sequence Number1
Patient Outcome(s) Hospitalization; Required Intervention;
Patient Age59 YR
Patient Weight107
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