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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ZIMMER BIOMET, INC. FEMUR TRABECULAR METAL POSTERIOR STABILIZED (PS) STANDARD POROUS PROSTHESIS, KNEE

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ZIMMER BIOMET, INC. FEMUR TRABECULAR METAL POSTERIOR STABILIZED (PS) STANDARD POROUS PROSTHESIS, KNEE Back to Search Results
Model Number N/A
Device Problems Unstable (1667); Loosening of Implant Not Related to Bone-Ingrowth (4002)
Patient Problems Ossification (1428); Pain (1994); Loss of Range of Motion (2032); Swelling (2091)
Event Date 02/18/2019
Event Type  Injury  
Manufacturer Narrative

(b)(4). Customer has indicated that the product will not be returned to zimmer biomet for investigation, as the device location is unknown. The investigation is in process. Once the investigation has been completed, a follow-up mdr will be submitted. Concomitant medical products: 00587806535, patella, lot # 63538625, 00588605712, tibial component, lot # 62047573.

 
Event Description

It was reported that approximately 2 years post implantation, the patient was revised due to pain, stiffness, instability, limited rom, and swelling. X-rays noted tibial cut was in significant varus. During the revision procedure, heterotopic ossification, poly wear, and loosening of the femoral component were noted. Attempts have been made and no further information has been provided.

 
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Brand NameFEMUR TRABECULAR METAL POSTERIOR STABILIZED (PS) STANDARD POROUS
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 Key9238248
MDR Text Key163772827
Report Number0001822565-2019-04617
Device Sequence Number1
Product Code MBH
Combination Product (Y/N)N
Reporter Country CodeUS
PMA/PMN NumberK122745
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type CONSUMER,HEALTH PROFESSIONAL
Reporter Occupation
Type of Report Initial,Followup
Report Date 03/10/2020
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received10/25/2019
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device MODEL NumberN/A
Device Catalogue Number42500806801
Device LOT Number63597279
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 Received03/09/2020
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured03/03/2017
Is The Device Single Use? Yes
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Patient TREATMENT DATA
Date Received: 10/25/2019 Patient Sequence Number: 1
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