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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ZIMMER MANUFACTURING B.V. PERSONA ARTICULAR SURFACE (UC) FIXED BEARING LEFT 12MM PROSTHESIS, KNEE

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ZIMMER MANUFACTURING B.V. PERSONA ARTICULAR SURFACE (UC) FIXED BEARING LEFT 12MM PROSTHESIS, KNEE Back to Search Results
Catalog Number 42512200412
Device Problem Unstable (1667)
Patient Problem Pain (1994)
Event Date 06/06/2017
Event Type  Injury  
Manufacturer Narrative
This follow-up report is being submitted to relay additional information. Concomitant medical product- femur cemented cruciate retaining (cr) narrow left size 5 catalog#: 42502005801 lot#: 63320862, tibia cemented 5 degree stemmed left size d catalog#: 42532006701 lot#: 63318851, all-poly patella cemented 29 mm diameter catalog#:42540200029 lot#: 63135525. Reported event was unable to be confirmed due to limited information received from the customer. 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 packaging insert, pain, dislocation and/or joint instability, and loosening of the prosthetic knee components are listed as potential adverse effects of the procedure. Root cause was unable to be determined as the necessary information to adequately investigate the reported event was not 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.
 
Manufacturer Narrative
(b)(4). Customer has indicated that the product will not be returned to zimmer biomet for investigation due to hospital retaining device. The investigation is in process. Once the investigation has been completed, a follow-up mdr will be submitted.
 
Event Description
It was reported following a knee arthroplasty, the patient was revised due to pain and instability. The congruent bearing was removed and replaced. Attempts have been made and additional information on the reported event is unavailable. No additional patient consequences were reported.
 
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Brand NamePERSONA ARTICULAR SURFACE (UC) FIXED BEARING LEFT 12MM
Type of DevicePROSTHESIS, KNEE
Manufacturer (Section D)
ZIMMER MANUFACTURING B.V.
turpeaux industrial park
route #1 km 123.4 bldg #1
mercedita PR 00715
Manufacturer (Section G)
ZIMMER MANUFACTURING B.V.
turpeaux industrial park
route #1 km 123.4 bldg #1
mercedita PR 00715
Manufacturer Contact
christina arnt
56 e. bell dr.
warsaw, IN 46582
5745273773
MDR Report Key6695178
MDR Text Key246604993
Report Number0002648920-2017-00439
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 09/26/2017
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received07/07/2017
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date05/31/2020
Device Catalogue Number42512200412
Device Lot Number63070867
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 Received09/26/2017
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured06/17/2015
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: 07/07/2017 Patient Sequence Number: 1
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