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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ZIMMER, INC. PERSONA ULTRA CONGRUENT ARTICULAR SURFACE KNEE PROSTHESIS

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ZIMMER, INC. PERSONA ULTRA CONGRUENT ARTICULAR SURFACE KNEE PROSTHESIS Back to Search Results
Catalog Number 42511200510
Device Problems Failure To Adhere Or Bond (1031); Pitted (1460)
Patient Problems Pain (1994); Synovitis (2094); Tissue Damage (2104); Osteolysis (2377)
Event Date 09/06/2016
Event Type  Injury  
Manufacturer Narrative

This report will be amended when our investigation is complete. Device received but not yet evaluated.

 
Event Description

It is reported that the patient had a knee arthroplasty revised due to preoperative radiographs demonstrating possible osteolysis and/or aseptic loosening as well as pain. Pitting and wear were noted on the articular surface during the revision surgery.

 
Manufacturer Narrative

Complaint sample was evaluated and the reported event was confirmed. Visual inspection of the returned components found that the articular surface exhibits excessive wear lines in both the medial and lateral compartments as well as gouges at the top of the patellar recess. Primary surgical notes state that the patient underwent tka for end-stage arthritis of the left knee. After resection of the acl and pcl, menisci, and osteophytes, the bones were prepared. Trialing with a 10mm size e ultracongruent liner gave full extension, 120 degrees of flexion, good stability to varus and valgus in flexion and extension were noted with good anterior and posterior drawer. The patellar provisional was implemented and tracked fine. Trial components were removed, the bony surfaces were copiously irrigated with antibiotic solution, and the final components were cemented in place with the knee kept in extension until the cement dried. The knee was again copiously irrigated and the final articular surface implemented. Range of motion and stability were similar as during trialing. The revision surgical notes state that the patient was revised due to aseptic loosening of the left knee. Intraoperatively, there was hypertrophic synovitis with extension eroding into the femur between the bone and cement interface. There were big bone defects on the lateral femoral condyle. A saw was used to remove the femoral component. The tibial component was loose and could be lifted off. There was no evidence of infection. The patella was good and solid and was left untouched. The articular surface was white and yellow and pitted and wear of this device was considered to have caused or contributed to aseptic loosening. The tibial plateau had a lot of cystic erosion mediolaterally. Device history record was reviewed and no discrepancies were found. Review of the complaint history determined that no further action is required as no trends were identified. A definitive root cause of the wear cannot be determined with the information provided. A summary of the investigation has been sent to the complainant. 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.

 
Manufacturer Narrative

This follow-up report is being submitted to relay additional information. Results of the sem analysis: foreign particles were identified on the bearing articulating surface, there were few suspected particles identified on both lateral and medial surfaces, although optical images does not reveal these suspected particles. Eds showed that they are consisted of c, o, na, cl, s, k, si, al, and mg. The base material showed only c and none of the other elements as found on the suspected foreign particles.

 
Manufacturer Narrative

This follow-up report is being submitted to relay additional information. Root cause remains undetermined. 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 is reported that the patient had a knee arthroplasty revised due to pain and radiographic evidence of possible osteolysis and/or aseptic loosening. Information received in medical records indicated hypertrophic synovitis with extension eroding into the femur between the bone and cement interface. There were bone defects on the lateral femoral condyle. The tibial component was loose and could be lifted off. There was no evidence of infection. The patella was good and solid and was left untouched. The articular surface was white and yellow and pitted and its wearing was considered to be the cause of the aseptic loosening. The tibial plateau had a lot of cystic erosion mediolaterally. No additional patient consequences were reported.

 
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Brand NamePERSONA ULTRA CONGRUENT ARTICULAR SURFACE
Type of DeviceKNEE PROSTHESIS
Manufacturer (Section D)
ZIMMER, INC.
1800 west center street
warsaw IN 46580
Manufacturer (Section G)
ZIMMER, INC.
1800 west center street
warsaw IN 46580
Manufacturer Contact
christina arnt
56 e. bell drive
warsaw, IN 46582
5745273773
MDR Report Key5983391
MDR Text Key55815738
Report Number0001822565-2016-03431
Device Sequence Number1
Product Code MBH
Combination Product (Y/N)N
Reporter Country CodeUS
PMA/PMN NumberPK121771
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type DISTRIBUTOR,HEALTH PROFESSION
Reporter Occupation
Type of Report Initial,Followup,Followup,Followup
Report Date 10/18/2017
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received09/28/2016
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device EXPIRATION Date06/30/2019
Device Catalogue Number42511200510
Device LOT Number62725638
OTHER Device ID NumberN/A
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer09/09/2016
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received10/11/2017
Was Device Evaluated By Manufacturer? Yes
Date Device Manufactured07/08/2014
Is The Device Single Use? Yes
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Patient TREATMENT DATA
Date Received: 09/28/2016 Patient Sequence Number: 1
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