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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 RIGHT SIZE D PROSTHESIS, KNEE

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ZIMMER ORTHOPAEDIC MFG. LTD. TIBIA CEMENTED 5 DEGREE STEMMED RIGHT SIZE D PROSTHESIS, KNEE Back to Search Results
Model Number N/A
Device Problem Loosening of Implant Not Related to Bone-Ingrowth (4002)
Patient Problem Failure of Implant (1924)
Event Date 02/11/2021
Event Type  Injury  
Manufacturer Narrative

(b)(4). Concomitant medical products: associated products : item#: 42500606602; femur cemented (ps) standard right size 9; lot#: 63355004. Item#:42522400511; art surface fixed bearing (ps) right 11 mm height; lot#: 63389417. Customer has indicated that the product will not be returned to zimmer biomet for investigation, as the patient acquired the devices. 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: 3007963827-2021-00036.

 
Event Description

It was reported a patient underwent a knee arthroplasty approximately 3. 5 years ago. Subsequently, was revised on due to femur and tibia becoming loose.

 
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Brand NameTIBIA CEMENTED 5 DEGREE STEMMED RIGHT SIZE D
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 Key11348900
MDR Text Key232559914
Report Number3007963827-2021-00037
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 DISTRIBUTOR,HEALTH PROFESSION
Reporter Occupation
Type of Report Initial,Followup
Report Date 03/30/2021
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received02/19/2021
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device MODEL NumberN/A
Device Catalogue Number42532006702
Device LOT Number63749592
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 Received03/23/2021
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured08/18/2017
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: 02/19/2021 Patient Sequence Number: 1
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