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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US UNK FEMORAL TRIAL

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DEPUY ORTHOPAEDICS INC US UNK FEMORAL TRIAL Back to Search Results
Catalog Number UNK FEMORAL TRIAL
Device Problems Entrapment of Device (1212); Off-Label Use (1494)
Patient Problems Not Applicable (3189); No Code Available (3191)
Event Date 08/17/2011
Event Type  Injury  
Manufacturer Narrative

(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

Revision operative notes (b)(6) 2011 indicate the patient received a left total hip revision due to retained trial head. The trial femoral head was retained and left in the patient on (b)(6) 2011 intentionally due to lack of availability of permanent femoral head at the time of the needed revision. Arthrotomy was performed with removal of the trial head and placement of the permanent femoral head implant. The surgery was completed without indication of complication by the surgeon. Doi: (b)(6) 2011; dor: (b)(6) 2011; (left hip).

 
Manufacturer Narrative

Product complaint # (b)(4). Investigation summary ==> the instrument associated with this report was not returned. Depuy considers the investigation closed at this time. Should additional information be received, the information will be reviewed and the investigation will be re-opened as necessary. If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

 
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Brand NameUNK FEMORAL TRIAL
Type of DeviceUNK FEMORAL TRIAL
Manufacturer (Section D)
DEPUY ORTHOPAEDICS INC US
700 orthopaedic drive
warsaw IN 46581 0988
Manufacturer (Section G)
DEPUY ORTHOPAEDICS, INC. 1818910
700 orthopaedic dr.
warsaw IN 46581 0988
Manufacturer Contact
kara ditty-bovard
1210 ward avenue
west chester, PA 19380-0988
6107428552
MDR Report Key9613555
MDR Text Key176382067
Report Number1818910-2020-02466
Device Sequence Number1
Product Code KWA
Combination Product (Y/N)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type COMPANY REPRESENTATIVE,HEALTH
Reporter Occupation OTHER HEALTH CARE PROFESSIONAL
Type of Report Initial,Followup
Report Date 01/07/2020
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received01/21/2020
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device Catalogue NumberUNK FEMORAL TRIAL
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 Received03/04/2020
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Is The Device Single Use? No Answer Provided
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Patient TREATMENT DATA
Date Received: 01/21/2020 Patient Sequence Number: 1
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