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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US S-ROM*SLEEVE PRX ZTT, 16D-SML S-ROM HIP SYSTEM : HIP FEMORAL SLEEVE

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DEPUY ORTHOPAEDICS INC US S-ROM*SLEEVE PRX ZTT, 16D-SML S-ROM HIP SYSTEM : HIP FEMORAL SLEEVE Back to Search Results
Model Number 55-0513
Device Problems Degraded; Loss of Osseointegration; Osseointegration Problem
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

The primary surgery was performed on (b)(6) 2008 via tha at another hospital (b)(6). It was reported that the revision surgery was performed on (b)(6) 2020 by replacing the stem (p/n: 900550210), the sleeve (p/n: 550513), the head (p/n: 152190057), the cup (p/n: unknown) and the liner (p/n: unknown) due to suspicion of armd, osteolysis and the loosening of the stem and the cup. During the surgery, it was confirmed that the implants were showed sign of black ring but there was no bone necrosis and soft tissue necrosis. The osteolysis occurred on large area. The revision surgery was completed with no surgical delay. The surgeon requested to investigate the stem¿s junction part (between the stem to neck, sleeve and inner boll). No further information is available.

 
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Type of DeviceS-ROM HIP SYSTEM : HIP FEMORAL SLEEVE
Manufacturer (Section D)
DEPUY ORTHOPAEDICS INC US
700 orthopaedic drive
warsaw IN 46581 0988
Manufacturer (Section G)
DEPUY IRELAND - 9616671
loughbeg ringaskiddy co.
cork
EI 
Manufacturer Contact
kara ditty-bovard
700 orthopaedic drive
warsaw , IN 46581-0988
6107428552
MDR Report Key10119691
Report Number1818910-2020-13214
Device Sequence Number1
Product CodeLPH
Report Source Manufacturer
Source Type COMPANY REPRESENTATIVE,FOREIG
Type of Report Initial,Followup,Followup,Followup
Report Date 05/25/2020
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received06/04/2020
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device MODEL Number55-0513
Device Catalogue Number550513
Device LOT Number2439609
Was Device Available For Evaluation? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received06/18/2020
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured08/07/2007
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: 06/04/2020 Patient Sequence Number: 1
Treatment
9/10 COCR HEAD 28MM -3
PINN LINER LIPPED 28IDX50OD
PINN-A MULTIHOLE ACET CUP 50MM
S-ROM*SLEEVE PRX ZTT, 16D-SML
SROM 9/10 16X11X130 30+4
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