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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ZIMMER ORTHOPAEDIC MFG. LTD. PERSONA NATURAL STEMMED CEMENTED TIBIAL COMPONENT 5 DEGREE LEFT SIZE E PROSTHESIS, KNEE

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ZIMMER ORTHOPAEDIC MFG. LTD. PERSONA NATURAL STEMMED CEMENTED TIBIAL COMPONENT 5 DEGREE LEFT SIZE E PROSTHESIS, KNEE Back to Search Results
Model Number N/A
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Muscle Weakness (1967); Nerve Damage (1979); Pain (1994); Numbness (2415)
Event Date 01/17/2018
Event Type  Injury  
Manufacturer Narrative

(b)(4). Concomitant medical devices - persona posterior cruciate retaining narrow porous femoral component left size 6 catalog #: 42502206001 lot #: 62504834, persona vivacit-e medial congruent articular surface left 13mm catalog #: 42512100713 lot #: 63307817, persona tapered cemented stem extension 14mm x 30mm catalog #: 42557000114 lot #: 63829925. It is indicated by the complainant that the devices will not be returned to zimmer biomet for investigation, as the devices currently remain implanted. 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 all reports associated with this event: 0001822565-2018-04434, 0001822565-2018-04435, 0001822565-2018-04436.

 
Event Description

It is reported that the patient was treated conservatively for pain, numbness and weakness that had developed in the left foot twelve (12) days following left knee arthroplasty. No additional patient consequences were reported.

 
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Brand NamePERSONA NATURAL STEMMED CEMENTED TIBIAL COMPONENT 5 DEGREE LEFT SIZE E
Type of DevicePROSTHESIS, KNEE
Manufacturer (Section D)
ZIMMER ORTHOPAEDIC MFG. LTD.
building no 2 east park
shannon industrial estate
shannon, county clare
EI
Manufacturer (Section G)
ZIMMER ORTHOPAEDIC MFG. LTD.
building no 2 east park
shannon industrial estate
shannon, county clare
EI
Manufacturer Contact
christina arnt
56 e. bell dr.
warsaw, IN 46582
5745273773
MDR Report Key7790693
MDR Text Key117353531
Report Number3007963827-2018-00135
Device Sequence Number1
Product Code MBH
Combination Product (Y/N)N
Reporter Country CodeUS
PMA/PMN NumberPK172524
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type COMPANY REPRESENTATIVE,CONSUM
Reporter Occupation
Type of Report Initial,Followup
Report Date 04/25/2019
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received08/16/2018
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator HEALTH PROFESSIONAL
Device MODEL NumberN/A
Device Catalogue Number42532007101
Device LOT Number63727131
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA? No
Event Location No Information
Date Manufacturer Received04/23/2019
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured07/20/2017
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: 08/16/2018 Patient Sequence Number: 1
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