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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ZIMMER BIOMET, INC. BIOMET CC CRUCIATE TRAY 75MM PROSTHESIS, KNEE

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ZIMMER BIOMET, INC. BIOMET CC CRUCIATE TRAY 75MM PROSTHESIS, KNEE Back to Search Results
Model Number N/A
Device Problems Loss of or Failure to Bond (1068); Unstable (1667); Migration (4003)
Patient Problems No Information (3190); Joint Laxity (4526)
Event Date 03/08/2019
Event Type  Injury  
Manufacturer Narrative
(b)(4). Concomitant medical products: van ps open intl fem-rt 65, catalog # 183108, lot # j3737946. Vngd ps+ tib brg 14x71/75mm, catalog # 183744, lot # 587560. Series a asymmetric pat 34x8. 5, catalog # 184793, lot # 614580. Palacos rg 1x40 single, catalog # 00111314001, lot # 83304476. Customer has indicated that the product will not be returned because 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 filled for this event: 0001825034-2020-03991.
 
Event Description
It was reported that the patient underwent a knee arthroplasty. Subsequently, the patient was revised due to aseptic loosening. Attempt for further information has been made, but no further information has been provided.
 
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Brand NameBIOMET CC CRUCIATE TRAY 75MM
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 Key10784258
MDR Text Key214520536
Report Number0001825034-2020-03989
Device Sequence Number1
Product Code OIY
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K142933
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,Followup
Report Date 03/12/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received11/04/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberN/A
Device Catalogue Number141234
Device Lot NumberJ3851571
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 Received03/09/2021
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured08/10/2016
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Invalid Data
Removal/Correction NumberN/A

Patient Treatment Data
Date Received: 11/04/2020 Patient Sequence Number: 1
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