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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ZIMMER BIOMET, INC. OSS REINFORCED YOKE PROSTHESIS, KNEE

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ZIMMER BIOMET, INC. OSS REINFORCED YOKE PROSTHESIS, KNEE Back to Search Results
Model Number N/A
Device Problems Adverse Event Without Identified Device or Use Problem (2993); Insufficient Information (3190)
Patient Problems Wound Dehiscence (1154); Bacterial Infection (1735); Necrosis (1971); Sepsis (2067); Insufficient Information (4580); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)
Event Date 02/01/2021
Event Type  Injury  
Manufacturer Narrative
(b)(4). Concomitant medical devices: 150480 - oss axle - 171230; 150477 - oss poly femoral bushings - 054370; 150354 - oss 7cm segmental femoral rt - 587060; 150410 - oss tibial poly bearing 12mm - 413680; 150478 - oss poly lock pin - 669540; 150476 - oss poly tibial bushing - 416420. The customer has indicated that the product will not be returned to zimmer biomet for investigation. 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: 0001825034-2021-00623, 0001825034-2021-00624, 0001825034-2021-00626, 0001825034-2021-00627, 0001825034-2021-00628, 0001825034-2021-00629.
 
Event Description
It was reported that the patient underwent a right knee revision. Subsequently, the patient was revised approximately one month later due to unknown reasons. Attempts have been made and no further information has been provided.
 
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Brand NameOSS REINFORCED YOKE
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 Key11423297
MDR Text Key235007002
Report Number0001825034-2021-00625
Device Sequence Number1
Product Code KRO
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K052685
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type distributor,health profession
Reporter Occupation
Type of Report Initial,Followup,Followup
Report Date 06/09/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received03/05/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Model NumberN/A
Device Catalogue Number150493
Device Lot Number264310
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 Received06/09/2021
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured02/28/2019
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: 03/05/2021 Patient Sequence Number: 1
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