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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ZIMMER ORTHOPAEDIC MFG. LTD. TIBIA CEMENTED 5 DEGREE STEMMED LEFT PROSTHESIS, KNEE

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ZIMMER ORTHOPAEDIC MFG. LTD. TIBIA CEMENTED 5 DEGREE STEMMED LEFT PROSTHESIS, KNEE Back to Search Results
Model Number N/A
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Pain (1994); Burning Sensation (2146); Ambulation Difficulties (2544)
Event Type  Injury  
Manufacturer Narrative

(b)(4). Additional concomitant medical products: persona uc articular surface, catalog #: 42511200412, lot #: 63551546; persona cr femur tm, catalog #: 42502205601, lot #: 63417242; prolong nexgen patella, catalog #: 00597206626, lot #: 62257588; palacos r 1x40 single, catalog #: 00111214001, lot #: 87494700; palacos cement, catalog #: unknown, lot #: unknown. Customer has indicated product will not be returned as product remains implanted. The investigation is in process. Once the investigation is completed, a follow-up report will be submitted. Multiple mdr reports were filed for this event, please see associated reports: 0001822565-2019-00846, 3007963827-2019-00056, 0001822565-2019-00847, 0001822565-2019-00848. 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. Device remains implanted in patient.

 
Event Description

It was reported patient underwent left total knee arthroplasty. Subsequently, patient is experiencing difficulty walking, pain and a burning sensation. No revision procedure has been reported to date.

 
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Brand NameTIBIA CEMENTED 5 DEGREE STEMMED LEFT
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 Key8372203
MDR Text Key137243116
Report Number3007963827-2019-00056
Device Sequence Number1
Product Code MBH
Combination Product (Y/N)N
Reporter Country CodeUS
PMA/PMN NumberK172524
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type CONSUMER,HEALTH PROFESSIONAL
Reporter Occupation
Type of Report Initial,Followup
Report Date 10/22/2019
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received02/26/2019
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator HEALTH PROFESSIONAL
Device MODEL NumberN/A
Device Catalogue Number42532006401
Device LOT Number63744321
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 Received10/21/2019
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured08/08/2017
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: 02/26/2019 Patient Sequence Number: 1
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