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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ZIMMER, INC. ZIMMER PERSONA THE PERSONALIZED KNEE SYSTEM PROSTHESIS, KNEE

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ZIMMER, INC. ZIMMER PERSONA THE PERSONALIZED KNEE SYSTEM PROSTHESIS, KNEE Back to Search Results
Catalog Number 42522400712
Device Problems Migration or Expulsion of Device (1395); Unstable (1667)
Patient Problem Pain (1994)
Event Date 02/03/2017
Event Type  Injury  
Manufacturer Narrative
(b)(4). Concomitant medical products: item name: zimmer persona the personalized knee system, catalog number: 42530007502, lot: 62365093. Item name: zimmer persona knee system, catalog number: 42500606202, lot number: 62300759. Customer has indicated that the product will not be returned to zimmer biomet for investigation. The investigation is in process. Once the investigation has been completed, a follow-up mdr will be submitted. Multiple mdr reports were filed for this event, please see associated reports: 0001822565-2017-01664 and 3007963827-2017-00023.
 
Event Description
It was reported that the patient underwent a total knee arthroplasty approximately 3 years ago and was revised for pain and instability. During the revision surgery, the surgeon noted the persona trabecular metal tibia was loose. He also determined the persona ps standard femoral component was malpositioned. Attempts have been made and additional information on the reported event is unavailable. No additional patient consequences were reported.
 
Manufacturer Narrative
Upon reassessment of the reported event, it was determined to be not reportable as this component was not related to the event. The initial report should be voided.
 
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Brand NameZIMMER PERSONA THE PERSONALIZED KNEE SYSTEM
Type of DevicePROSTHESIS, KNEE
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 Key6396803
MDR Text Key69644050
Report Number0001822565-2017-01665
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 distributor,health profession
Reporter Occupation
Type of Report Initial,Followup
Report Date 06/02/2017
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received03/10/2017
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date03/31/2018
Device Catalogue Number42522400712
Device Lot Number62315376
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received05/05/2017
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured04/08/2013
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: 03/10/2017 Patient Sequence Number: 1
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