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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ZIMMER BIOMET, INC. NATURAL TIBIA TRABECULAR METAL TWO-PEG POROUS FIXED BEARING PROSTHESIS, KNEE

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ZIMMER BIOMET, INC. NATURAL TIBIA TRABECULAR METAL TWO-PEG POROUS FIXED BEARING PROSTHESIS, KNEE Back to Search Results
Model Number N/A
Device Problem Migration (4003)
Patient Problem Failure of Implant (1924)
Event Date 06/17/2021
Event Type  Injury  
Manufacturer Narrative

(b)(4). Concomitant medical products: 42502606402 - femur cemented cruciate retaining (cr) standard right size 8 - 64824134. 42522100813 - articular surface medial congruent (mc) right 13 mm height use with tibia. Sizes e-f/cr femur sizes 8-11 - 64411366. 42540200035 - all-poly patella cemented 35 mm diameter - 64833139. 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 the patient underwent a right total knee arthroplasty. Subsequently, the patient underwent a revision procedure approximately 1 month later due to tibial subsidence. Attempts have been made and no further information has been provided.

 
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Brand NameNATURAL TIBIA TRABECULAR METAL TWO-PEG POROUS FIXED BEARING
Type of DevicePROSTHESIS, KNEE
Manufacturer (Section D)
ZIMMER BIOMET, INC.
56 e. bell drive
warsaw IN 46582
Manufacturer (Section G)
ZIMMER BIOMET, INC.
56 e. bell drive
warsaw IN 46582
Manufacturer Contact
christina arnt
56 e. bell dr.
warsaw, IN 46582
5745273773
MDR Report Key12121368
MDR Text Key260034472
Report Number0001822565-2021-01814
Device Sequence Number1
Product Code MBH
Combination Product (Y/N)N
Reporter Country CodeAS
PMA/PMN NumberK173417
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 07/21/2021
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received07/06/2021
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device MODEL NumberN/A
Device Catalogue Number42530007102
Device LOT Number64696407
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 Received07/21/2021
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured08/05/2020
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: 07/06/2021 Patient Sequence Number: 1
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