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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ZIMMER INC PERSONA POROUS 2 PEGGED TRABECULAR METAL TIBIAL COMPONENT KNEE PROSTHESIS

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ZIMMER INC PERSONA POROUS 2 PEGGED TRABECULAR METAL TIBIAL COMPONENT KNEE PROSTHESIS Back to Search Results
Catalog Number 42530007102
Device Problem Failure To Adhere Or Bond (1031)
Patient Problems Pain (1994); Limited Mobility Of The Implanted Joint (2671)
Event Date 12/30/2015
Event Type  Injury  
Manufacturer Narrative

Information was received from a consumer who is not required to complete form 3500a. (b)(4). The devices remain implanted; therefore the condition of the components is unknown. The device history records could not be reviewed as the part and lot number is unknown. This device is used for treatment. Surgical notes were not provided; it is unknown whether the components were implanted with the correct fit and orientation as per the surgical technique. A definitive root cause cannot be determined with the information provided.

 
Event Description

It is reported that the patient is experiencing restriction and pain when bending her knee. X-rays reportedly show that the implant has pulled away from the bone. Revision surgery has been scheduled for (b)(6) 2015.

 
Manufacturer Narrative

This report will be amended when our investigation is complete.

 
Event Description

It is now known that the patient underwent right knee arthroplasty revision due to tibial loosening.

 
Manufacturer Narrative

This follow-up report is being submitted to relay additional information. Concomitant product: nexgen complete knee solution standard primary patella ¿ cat. No. Not provided; lot no. 62593968, femur cr nrw ¿ cat. No. 42-5022-064-02; lot no. 62621307, articular surface ¿ cat. No. 42-5220-005-10; lot no. 62342604. Reported event was confirmed by review of op notes. Review of the revision operative notes indicates that the patella and femur found to be well fixed but the tibia was found to be loose. Device history record was reviewed and no discrepancies relevant to the reported event were found. The problem with this device constitutes a "design issue" as the root cause. 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. Visual evaluation of the returned tibial component found that its superior surface was gouged and discolored. The two pegs were still attached to the inferior surface and remnant of a foreign substance (bone cement) was uneven, especially it was not present on the hexagonal sides of the pegs 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 NamePERSONA POROUS 2 PEGGED TRABECULAR METAL TIBIAL COMPONENT
Type of DeviceKNEE PROSTHESIS
Manufacturer (Section D)
ZIMMER INC
p.o. box 708
warsaw IN 46581 0708
Manufacturer (Section G)
ZIMMER BIOMET, INC.
56 e. bell drive
warsaw IN 46582
Manufacturer Contact
christina arnt
56 e. bell dr.
warsaw, IN 46582-0708
5745273773
MDR Report Key5278165
MDR Text Key33042978
Report Number1822565-2015-02611
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 COMPANY REPRESENTATIVE,CONSUM
Reporter Occupation
Type of Report Initial,Followup,Followup,Followup
Report Date 02/06/2019
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received12/09/2015
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device Catalogue Number42530007102
Device LOT Number62490330
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer01/19/2018
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA? No
Event Location No Information
Date Manufacturer Received02/04/2019
Was Device Evaluated By Manufacturer? Yes
Date Device Manufactured11/09/2013
Is The Device Single Use? Yes
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Removal/Correction NumberZ-1266-2015

Patient TREATMENT DATA
Date Received: 12/09/2015 Patient Sequence Number: 1
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