MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS, INC. 1818910 SROM*STM LG 36+8L 18X13X215N; S-ROM HIP SYSTEM : HIP FEMORAL STEM

Catalog Number	563118N
Medical Device Problem Codes	Loss of Osseointegration (2408); Osseointegration Problem (3003)
Health Effect - Clinical Codes	Pain (1994); Deformity/ Disfigurement (2360); Inadequate Osseointegration (2646); No Code Available (3191)
Date of Event	09/16/2009
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+9 hip femoral head.Pinnacle mtl ins neut40idx56od hip acetabular liner.Unknown hip acetabular cup.Srom*stm lg 36+8l 18x13x215n hip femoral stem.Unknown hip proximal femoral sleeve.Initial reporter occupation: non-healthcare professional ¿ attorney.(b)(4).
Event or Problem Description
Litigation papers allege: sustained and continues to suffer economic damages (including medical and hospital expenses) severe and possibly permanent injuries, disability, disfigurement, pain, suffering and emotional distress.In addition to what was previously alleged, ppf alleges loosening of stem.Added stem due to the alleged loosening.Doi: (b)(6) 2007; dor: (b)(6) 2009; (right hip).
Additional Manufacturer Narrative
Udi: (b)(4).
Additional Manufacturer Narrative
Depuy synthes is submitting this report pursuant to the provision of 21 cfr, part 803.The report may be based on the information which depuy synthes has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, depuy synthes or its employees that the report constitutes an admission that the device, depuy synthes, or its employees caused or contributed to the potential event described in this report.Product complaint # (b)(4).Investigation summary : no device associated with this report was received for examination.A worldwide complaint database search found no other related reported incidents against the provided product code/lot number combination since release for distribution.Based on previous investigations, this complication of joint replacement is unlikely to have been the result of a device failing to meet required specifications.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.Device history lot : null.Device history batch : null.Device history review : null.If information is obtained that was not available for the initial 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 0988
• MDR Report Key: 8039768
• Report Number: 1818910-2018-74559
• Device Sequence Number: 1643443
• Product Code: JDI
• UDI-Device Identifier: 10603295177821
• UDI-Public: 10603295177821
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K851422
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2007
• Reporter Type: Manufacturer
• Report Source: consumer,other
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 10/08/2018

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: 563118N
• Device Lot Number: 2385703
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 10/08/2018
• Supplement Date Received by Manufacturer: 12/18/2018; 09/23/2019
• Initial Report FDA Received Date: 11/05/2018
• Supplement Report FDA Received Date: 12/20/2018; 10/21/2019
• 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: 47 YR