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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS, INC. ATTUNE CONV FB PS TB TRL SZ5 KNEE INSTRUMENT/TRIAL

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DEPUY ORTHOPAEDICS, INC. ATTUNE CONV FB PS TB TRL SZ5 KNEE INSTRUMENT/TRIAL Back to Search Results
Catalog Number 254500975
Device Problem Break (1069)
Patient Problem Device Embedded In Tissue or Plaque (3165)
Event Date 04/22/2016
Event Type  Injury  
Manufacturer Narrative

This complaint is still under investigation. Depuy will notify the fda of the results of this investigation once it has been completed. (b)(4). If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

 
Event Description

Although there was no abnormality by x-rays taken just after the surgery, the surgeon found a part of surgical instruments left in the patient's body during routine medical checkup. It was reported that the part seemed to be the balseal of the reported device. There seems to be no anomaly to the patient at this point, therefore they will continue the follow-up observations.

 
Manufacturer Narrative

The device associated with this report was not returned, however review of the provided x-rays confirms the reported event of a balseal remaining in the patient. Hhe/qrb (quality review board) (b)(4) recommended a device correction which was initiated on june 12, 2015. Capa-(b)(4) determined the likely root cause to be related to misuse, and requires mandatory sales training on proper use and application of the device by depuy sales consultants. Capa-(b)(4) will also monitor the mandatory field training. The need for further corrective action was not indicated. Continue to monitor disassociation events per post market surveillance sep-419. 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 CONV FB PS TB TRL SZ5
Type of DeviceKNEE INSTRUMENT/TRIAL
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 Key5614335
MDR Text Key43850663
Report Number1818910-2016-18240
Device Sequence Number1
Product Code MBH
Combination Product (Y/N)N
Reporter Country CodeUS
PMA/PMN NumberPK140881
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type FOREIGN,HEALTH PROFESSIONAL
Reporter Occupation HEALTH PROFESSIONAL
Type of Report Initial,Followup
Report Date 04/22/2016
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received04/28/2016
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device Catalogue Number254500975
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 Received05/03/2016
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Is The Device Single Use? No
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unkown

Patient TREATMENT DATA
Date Received: 04/28/2016 Patient Sequence Number: 1
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