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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ZIMMER BIOMET, INC. ARTICULAR SURFACE FIXED BEARING POSTERIOR STABILIZED (PS) RIGHT 12 MM HEIGHT PROSTHESIS, KNEE

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ZIMMER BIOMET, INC. ARTICULAR SURFACE FIXED BEARING POSTERIOR STABILIZED (PS) RIGHT 12 MM HEIGHT PROSTHESIS, KNEE Back to Search Results
Model Number N/A
Device Problems Patient Device Interaction Problem (4001); Loosening of Implant Not Related to Bone-Ingrowth (4002)
Patient Problems Loss of Range of Motion (2032); Scar Tissue (2060)
Event Date 05/30/2018
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: 42532006702, tibia, lot # 62331211; 42500606002, femur, lot # 62364751; 00111314001, bone cement, lot # 76404338; 00111314001, bone cement, lot # 76684363; 00111314001, bone cement, lot # 77584367; 00111314001, bone cement, lot # 76394338; 42540000032, poly patella, lot # 62268836; 42522400512, bearing, lot # 62488904. Multiple mdr reports were filed for this event, please see associated reports: 0001822565-2018-02910, 3007963827-2018-00092, 0001822565-2018-02914, 0001822565-2018-02913, 0001822565-2018-02912, 0001822565-2019-04277.

 
Event Description

It was reported that approximately 4 years post implantation, the patient was revised of the right knee due to aseptic loosening and arthrofibrosis with limited range of motion. Attempts have been made and no further information has been provided.

 
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Brand NameARTICULAR SURFACE FIXED BEARING POSTERIOR STABILIZED (PS) RIGHT 12 MM HEIGHT
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 Key9145897
MDR Text Key164502874
Report Number0001822565-2019-04278
Device Sequence Number1
Product Code MBH
Combination Product (Y/N)N
Reporter Country CodeUS
PMA/PMN NumberK121771
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type CONSUMER,HEALTH PROFESSIONAL
Reporter Occupation
Type of Report Initial,Followup,Followup
Report Date 03/27/2020
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received10/02/2019
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device EXPIRATION Date09/30/2018
Device MODEL NumberN/A
Device Catalogue Number42522400512
Device LOT Number62488904
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 Received03/26/2020
Was Device Evaluated By Manufacturer? Yes
Date Device Manufactured10/04/2013
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: 10/02/2019 Patient Sequence Number: 1
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