MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS, INC. 1818910 SROM*STM STD,36NK,20X15X165; S-ROM HIP SYSTEM : HIP FEMORAL STEM

Catalog Number	523194
Medical Device Problem Code	Loss of Osseointegration (2408)
Health Effect - Clinical Code	Inadequate Osseointegration (2646)
Date of Event	08/30/2018
Type of Reportable Event	Serious Injury
Additional 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 or Problem Description
Patient was revised to address loosening of the femoral component at bone to implant interface.Doi: unknown; dor: (b)(6) 2018; right hip.
Additional 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. .

• Common Device Name: S-ROM HIP SYSTEM : HIP FEMORAL STEM
• Manufacturer (Section D): DEPUY ORTHOPAEDICS, INC. 1818910 ; 700 orthopaedic drive; warsaw IN 46582 0998
• MDR Report Key: 7906050
• Report Number: 1818910-2018-70388
• Device Sequence Number: 19200647
• Product Code: JDI
• UDI-Device Identifier: 10603295170884
• UDI-Public: 10603295170884
• Combination Product (Y/N): N
• Initial Reporter State: IN
• Initial Reporter Country: US
• PMA/510(K) Number: K851422
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Explanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 08/30/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Catalogue Number: 523194
• Device Lot Number: 2317140
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 08/30/2018
• Supplement Date Received by Manufacturer: 09/27/2018
• Initial Report FDA Received Date: 09/25/2018
• Supplement Report FDA Received Date: 09/28/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 32 YR