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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ZIMMER, INC. ARTICULAR SURFACE FIXED BEARING CRUCIATE RETAINING (CR) LEFT 12 MM HEIGHT PERSONA CR VE ARTICULAR SURFACE

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ZIMMER, INC. ARTICULAR SURFACE FIXED BEARING CRUCIATE RETAINING (CR) LEFT 12 MM HEIGHT PERSONA CR VE ARTICULAR SURFACE Back to Search Results
Model Number N/A
Device Problem Unstable (1667)
Patient Problems Pain (1994); Ambulation Difficulties (2544); No Information (3190)
Event Date 08/11/2015
Event Type  Injury  
Event Description
It was reported that the patient had initial left total knee arthroplasty. Subsequently, was revised due to pain, ambulating difficulties, use of assistive device and instability approximately on (1) year, nine (9) months post primary implantation.
 
Manufacturer Narrative
The reported event was confirmed by visual evaluation of received product which noted nicks, gouges and the dovetail feature was flared out. The root cause remains undetermined. If any further information is found which would change or alter any conclusions or information, a supplemental report will be filed accordingly. Zimmer biomet will continue to monitor for trends.
 
Manufacturer Narrative
Concomitant medical products: zimmer persona cr femoral porous, standard, size 9, left, catalog #42502806601 lot# 62397938, zimmer persona two-peg trabecular metal tibia, tm size g, catalog #42530007901 lot#62428602, zimmer nexgen trabecular metal standard primary patella size 35 mm catalog # 00587806535 lot #62382685. Complaint operative notes were evaluated and the reported event was confirmed. No devices or photos were received; therefore the condition of the components are unknown. Review of the primary operative notes confirms that the patient underwent a left total knee arthroplasty due to severe degenerative joint disease of left knee. Trials were inserted and range of motion and stability were checked. The final components were placed with cement less technique and stability was rechecked. The surgeon followed the right technique. Review of the revision op notes confirms that the patient underwent a revision of left total knee arthroplasty due to instability, including femur as well as tibial component. X-rays demonstrated apparent satisfactory positioning of his components without any evidence of loosening. Pain started after several months of initial surgery and patient was unresponsive to all treatment efforts. The tibial component was well fixed. Dhr was reviewed and no discrepancies relevant to the reported event were found. Review of the complaint history determined that no further action is required as no were trends identified. Per the persona knee system package insert instability is a known risk of this procedure. A definitive root cause cannot be determined with the information provided. 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 had revision surgery due to a recalled zimmer persona trabecular metal tibial implant. But our investigation shows patient underwent a revision of left total knee arthroplasty due to instability.
 
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Brand NameARTICULAR SURFACE FIXED BEARING CRUCIATE RETAINING (CR) LEFT 12 MM HEIGHT
Type of DevicePERSONA CR VE ARTICULAR SURFACE
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 dr.
warsaw, IN 46582
5745273773
MDR Report Key6480190
MDR Text Key241261350
Report Number0001822565-2017-02139
Device Sequence Number1
Product Code OIY
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
PK121771
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type consumer,health professional
Reporter Occupation Attorney
Type of Report Initial,Followup
Report Date 09/10/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received04/11/2017
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Expiration Date04/30/2018
Device Model NumberN/A
Device Catalogue Number42512000612
Device Lot Number62338843
Other Device ID NumberN/A
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer11/01/2018
Is the Reporter a Health Professional? No
Was the Report Sent to FDA? No
Event Location Hospital
Date Manufacturer Received09/09/2019
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured05/10/2013
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: 04/11/2017 Patient Sequence Number: 1
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