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

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.  .

• Type of Device: S-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 Key: 7906021
• MDR Text Key: 121611550
• Report Number: 1818910-2018-70385
• Device Sequence Number: 1
• Product Code: MEH
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K912713
• Number of Events Reported: 1
• 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 Received: 09/25/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No

Device Operator

• Device Catalogue Number: 550109
• Device Lot Number: 1828779
• 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 Received: 09/27/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/09/2005
• 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