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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ZIMMER BIOMET, INC. BIOMET ILOK PRI TIB TRAY 71MM PROSTHESIS KNEE

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ZIMMER BIOMET, INC. BIOMET ILOK PRI TIB TRAY 71MM PROSTHESIS KNEE Back to Search Results
Model Number N/A
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Pain (1994); Ambulation Difficulties (2544)
Event Type  Injury  
Manufacturer Narrative
(b)(4). Medical products: vanguard cr ilok fem-rt 62. 5 catalog # 183006 lot # j6555744. Vngd cr lip tib brg 16x71/75mm catalog # 183546 lot # 324420. Series a pat std 34 3 peg catalog # 184766 lot # 613630. Biomet finned pri stem 40mm catalog # 141314 lot # 978350. Stryker cement catalog # unknown lot # unknown. Customer has indicated that the product will not be returned because it remains implanted. 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: 0001825034-2021-02314 0001825034-2021-02315 0001825034-2021-02316 0001825034-2021-02317. Remains implanted.
 
Event Description
It was reported that the patient underwent a knee arthroplasty. Subsequently, the patient was experiencing pain and a crooked knee post surgery. Additionally, the patient was walking differently. No revision procedure has been reported to date. Attempt for further information has been made, but no further information has been provided.
 
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Brand NameBIOMET ILOK PRI TIB TRAY 71MM
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 Key12281018
MDR Text Key265172399
Report Number0001825034-2021-02306
Device Sequence Number1
Product Code OIY
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K915132
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Consumer,Health Professional,Distributor
Reporter Occupation
Type of Report Initial,Followup
Report Date 11/23/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received08/05/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Model NumberN/A
Device Catalogue Number141213
Device Lot Number686560
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? No
Date Manufacturer Received11/17/2021
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured07/09/2019
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: 08/05/2021 Patient Sequence Number: 1
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