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U.S. Department of Health and Human Services

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

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ZIMMER ORTHOPAEDIC MFG. LTD. NATURAL TIBIA CEMENTED 5 DEGREE STEMMED LEFT SIZE E PROSTHESIS, KNEE Back to Search Results
Model Number N/A
Device Problem Migration (4003)
Patient Problem Failure of Implant (1924)
Event Date 05/05/2021
Event Type  Injury  
Manufacturer Narrative

(b)(4). Concomitant medical products: 42512000511 - articular surface fixed bearing cruciate retaining (cr) left 11 mm height - 64194997. 00890103533 - hex screw - 64508044. 42502606201 - femoral component - 64465177. 42540200035 - patellar component - 64621989. Report source: foreign country: (b)(6). The customer has indicated that the product will not be returned to zimmer biomet for investigation. The investigation is in process. Once the investigation has been completed, a follow-up mdr will be submitted.

 
Event Description

It was reported that a patient underwent an initial knee arthroplasty. Subsequently, the patient was revised approximately 1 year later due to tibial subsidence. Attempts have been made and no further information has been provided.

 
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Brand NameNATURAL TIBIA CEMENTED 5 DEGREE STEMMED 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 Key11929706
MDR Text Key255933960
Report Number3007963827-2021-00117
Device Sequence Number1
Product Code MBH
Combination Product (Y/N)N
Reporter Country CodeAS
PMA/PMN NumberK172524
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type DISTRIBUTOR,FOREIGN,HEALTH PR
Reporter Occupation
Type of Report Initial,Followup
Report Date 06/21/2021
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received06/03/2021
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device MODEL NumberN/A
Device Catalogue Number42532007101
Device LOT Number64616453
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 Received06/17/2021
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured03/04/2020
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: 06/03/2021 Patient Sequence Number: 1
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