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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS, INC. 1818910  S-ROM*SLEEVE PRX ZT HA 20B-SML S-ROM HIP SYSTEM : HIP FEMORAL SLEEVE

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DEPUY ORTHOPAEDICS, INC. 1818910  S-ROM*SLEEVE PRX ZT HA 20B-SML S-ROM HIP SYSTEM : HIP FEMORAL SLEEVE Back to Search Results
Catalog Number 550109
Device Problem Loss of Osseointegration (2408)
Patient Problem Inadequate Osseointegration (2646)
Event Date 08/30/2018
Event Type  Injury  
Manufacturer Narrative
Product complaint # (b)(4). If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate. Concomitant medical products: 11/13 s-rom 40mm m spec+6 hip femoral head; pinnacle mtl ins neut 40idx56od hip acetabular liner; unknown hip acetabular cup; srom*stm std,36nk,20x15x165 hip femoral stem; s-rom*sleeve prx zt ha 20b-sml hip femoral sleeve; pinn can bone screw 6. 5mmx40mm hip acetabular screw; pinn can bone screw 6. 5mmx30mm hip acetabular screw; pinn can bone screw 6. 5mmx25mm hip acetabular screw; pinn can bone screw 6. 5mmx15mm hip acetabular screw.
 
Event Description
Patient was revised to address loosening of the femoral component at bone to implant interface. Doi: unknown; dor: (b)(6) 2018; right hip.
 
Manufacturer Narrative
Product complaint: (b)(4). Investigation summary: no device associated with this report was received for examination. 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. Depuy considers the investigation closed. 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, a follow-up medwatch will be filed as appropriate.  .
 
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Type of DeviceS-ROM HIP SYSTEM : HIP FEMORAL SLEEVE
Manufacturer (Section D)
DEPUY ORTHOPAEDICS, INC. 1818910 
700 orthopaedic drive
warsaw IN 46582 0998
Manufacturer (Section G)
DEPUY IRELAND 9616671
loughbeg, ringaskiddy co.
cork
EI
Manufacturer Contact
chad gibson
700 orthopaedic drive
warsaw, IN 46582-0998
5743725905
MDR Report Key7906021
MDR Text Key121611550
Report Number1818910-2018-70385
Device Sequence Number1
Product Code MEH
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K912713
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Reporter Occupation
Type of Report Initial,Followup
Report Date 08/30/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received09/25/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Catalogue Number550109
Device Lot Number1828779
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 Received09/27/2018
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured10/09/2005
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: 09/25/2018 Patient Sequence Number: 1
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