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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ZIMMER MANUFACTURING B.V. PERSONA ALL POLYETHYLENE PATELLA PROSTHESIS, KNEE

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ZIMMER MANUFACTURING B.V. PERSONA ALL POLYETHYLENE PATELLA PROSTHESIS, KNEE Back to Search Results
Model Number N/A
Device Problem Insufficient Information (3190)
Patient Problems Nerve Damage (1979); Pain (1994); Limited Mobility Of The Implanted Joint (2671)
Event Date 02/17/2017
Event Type  Injury  
Manufacturer Narrative

(b)(4). Concomitant medical products: nexgen gender solution femoral component, catalog#: 00575001401, lot#: 62134275; nexgen stemmed tibial component, catalog#: 00598003702, lot#: 62126939; nexgen prolong articular surface, catalog#: 90595203020, lot#: 62049246. Customer has indicated that the product will not be returned to zimmer biomet for investigation, as product location is unknown. The investigation is in process. Once the investigation has been completed, a follow-up mdr will be submitted. 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. Multiple mdr reports were filed for this event, please see associated reports: 3007963827-2017-00025, 0002648920-2018-00044, 0001822565-2018-00363.

 
Event Description

It is reported that after a knee arthroplasty the patient experienced pain, limited mobility, and warm to touch knee. The patient underwent a surgery to treat a neuroma excision. Attempts have been made and additional information on the reported event is unavailable at this time.

 
Manufacturer Narrative

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.

 
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Brand NamePERSONA ALL POLYETHYLENE PATELLA
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 Key7193905
MDR Text Key97339500
Report Number0002648920-2018-00045
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 HEALTH PROFESSIONAL
Reporter Occupation
Type of Report Initial,Followup,Followup
Report Date 03/12/2018
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received01/16/2018
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? Yes
Device Operator
Device EXPIRATION Date05/31/2020
Device MODEL NumberN/A
Device Catalogue Number42540200032
Device LOT Number63080070
OTHER Device ID NumberN/A
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 Received02/12/2018
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured06/26/2015
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: 01/16/2018 Patient Sequence Number: 1
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