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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS, INC. ATTUNE CR FB INSRT SZ 7 6MM KNEE TIBIAL BEARING/INSERT

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DEPUY ORTHOPAEDICS, INC. ATTUNE CR FB INSRT SZ 7 6MM KNEE TIBIAL BEARING/INSERT Back to Search Results
Catalog Number 151620706
Device Problem Insufficient Information (3190)
Patient Problem Unspecified Infection (1930)
Event Date 03/03/2017
Event Type  Injury  
Manufacturer Narrative
Udi: (b)(4). Depuy synthes has been informed that the lot number is not available. This complaint is still under investigation. Depuy will notify the fda of the results of this investigation once it has been completed.
 
Event Description
Patient was revised to address infection.
 
Manufacturer Narrative
No device associated with this report was received for examination. A worldwide lot specific complaint database search, or device history record (dhr) review was not possible because the required lot code(s) was not provided. Based on previous investigations this complication of joint replacement is unlikely to have been the result of a device failing to meet required specifications. The information received will be retained for potential series investigations if triggered by trend analysis, post market surveillance, or other events within the quality system. Corrective action was not indicated. Depuy considers the investigation closed at this time. Should the additional information be received, the information will be reviewed and the investigation will be re-opened as necessary.
 
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Brand NameATTUNE CR FB INSRT SZ 7 6MM
Type of DeviceKNEE TIBIAL BEARING/INSERT
Manufacturer (Section D)
DEPUY ORTHOPAEDICS, INC.
700 orthopaedic drive
warsaw IN 46582
Manufacturer (Section G)
DEPUY ORTHOPAEDICS, INC.
700 orthopaedic drive
warsaw IN 46582
Manufacturer Contact
chad gibson
700 orthopaedic drive
warsaw, IN 46581
5743725905
MDR Report Key6407674
MDR Text Key70030382
Report Number1818910-2017-14725
Device Sequence Number1
Product Code OIY
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K090622
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type distributor,health profession
Reporter Occupation
Type of Report Initial,Followup
Report Date 03/03/2017
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received03/15/2017
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Catalogue Number151620706
Device Lot NumberUNKNOWN
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 Received03/08/2017
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
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: 03/15/2017 Patient Sequence Number: 1
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