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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 Problem Insufficient Information (3190)
Patient Problems Pain (1994); Staphylococcus Aureus (2058); Swelling (2091)
Event Date 03/04/2017
Event Type  Injury  
Manufacturer Narrative
(b)(4). Concomitant medical products: item # 150476; oss poly tibial bushing, lot # 510910, item # 150477; oss poly femoral bushings 2pk, lot # 780760, item # 150478; oss poly lock pin; lot #576750, item # 150412; oss tibial poly bearing; lot # 231210, item # 150480; oss axle; lot # 274490, item # 150355; oss segmental femoral lt; lot # 919810, item # 150481; diah seg lock screw set; lot # 935180, item # 150419; oss non-mod tib plate long; lot # 612080, item # 150426; oss tib blk aug univ; lot # 015450, item # 150426; oss tib blk aug univ; lot # 896800, item # 150461; oss ellip diaphyseal seg; lot # 755520, item # 150368; oss cemented im stem ; lot # 691040. Reported event was confirmed by review of operative notes. Device history record (dhr) was reviewed and no discrepancies relevant to the reported event were found. Review of the complaint history determined that no further actions are required. Investigation results concluded that the reported event was due to cause of the infection is attributed to both the manufacturing and quality system issue and the reuse of the femoral implant. If any further information is found which would change or alter any conclusions or information, a supplemental will be filed accordingly. Zimmer biomet will continue to monitor for trends. Multiple mdr reports were filed for this event, please see associated reports: 1825034-2017-02328, 1825034-2017- 02329,1825034-2017-02330.
 
Event Description
It was reported that the patient was experiencing pain and effusion after a knee revision procedure, subsequently, the patient tested positive for (b)(6) and was revised approximately two months post implantation. No additional patient consequences were reported.
 
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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 Key7207693
MDR Text Key97849245
Report Number0001825034-2018-00274
Device Sequence Number1
Product Code KRO
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
PK052685
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type distributor,health profession
Reporter Occupation
Type of Report Initial
Report Date 01/12/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received01/19/2018
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 Number066340
Other Device ID Number(01) 00880304240090
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received11/29/2017
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured12/07/2016
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage
Removal/Correction NumberN/A

Patient Treatment Data
Date Received: 01/19/2018 Patient Sequence Number: 1
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