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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ZIMMER MANUFACTURING B.V. TIBIA CEMENTED 5 DEGREE STEMMED RIGHT SIZE F PROSTHESIS, KNEE

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ZIMMER MANUFACTURING B.V. TIBIA CEMENTED 5 DEGREE STEMMED RIGHT SIZE F PROSTHESIS, KNEE Back to Search Results
Model Number N/A
Device Problem Migration (4003)
Patient Problem No Information (3190)
Event Date 05/28/2019
Event Type  Injury  
Manufacturer Narrative

(b)(4). Concomitant medical products: patell item # unknown lot 3 unknown, art surface item # 42522400711 lot # 63119959, femur item # 42500606402 lot # unknown. Customer has indicated that the product will not be returned to zimmer biomet for investigation as the hospital will no permit. 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 procedure; subsequently 30 months later the patient was revised due to loosening. Presumed loosening of tibial component.

 
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Brand NameTIBIA CEMENTED 5 DEGREE STEMMED RIGHT SIZE F
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 Key8715629
MDR Text Key148522297
Report Number0002648920-2019-00430
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 10/15/2019
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received06/20/2019
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device MODEL NumberN/A
Device Catalogue Number42532007502
Device LOT Number63133996
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 Received10/10/2019
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured09/25/2015
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: 06/20/2019 Patient Sequence Number: 1
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