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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ZIMMER BIOMET, INC. TIBIA CEMENTED 5 DEGREE STEMMED RIGHT SIZE E PROSTHESIS, KNEE

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ZIMMER BIOMET, INC. TIBIA CEMENTED 5 DEGREE STEMMED RIGHT SIZE E PROSTHESIS, KNEE Back to Search Results
Model Number N/A
Device Problem Loosening of Implant Not Related to Bone-Ingrowth (4002)
Patient Problems Bone Fracture(s) (1870); Pain (1994)
Event Date 10/28/2019
Event Type  Injury  
Manufacturer Narrative

(b)(4). (b)(4): 00111214001 - palacos r 1x40 single - 87524706, 42540000032 - all poly patella cemented 32 mm diameter - 63940183, 42500006002 - femur cemented posterior stabilized (ps) - 63819645, 42521400710 - articular surface fixed bearing posterior stabilized (ps) - 63844848. Customer has indicated that the product will not be returned to zimmer biomet for investigation, as the product location is unknown. 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: 0001822565-2020-01201.

 
Event Description

It was reported that the patient underwent a right knee revision approximately 19 months post implantation due to pain and loosening at the cement interface. It was also noted the patient suffered from a hairline fracture.

 
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Brand NameTIBIA CEMENTED 5 DEGREE STEMMED RIGHT SIZE E
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 Key9904357
MDR Text Key187367795
Report Number0001822565-2020-01200
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,DISTRIBUTOR,HEALTH P
Reporter Occupation
Type of Report Initial,Followup
Report Date 07/07/2020
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received03/31/2020
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device MODEL NumberN/A
Device Catalogue Number42532007102
Device LOT Number63776398
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 Received07/06/2020
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured10/06/2017
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: 03/31/2020 Patient Sequence Number: 1
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