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

Catalog Number 563118N

Device Problems Loss of Osseointegration (2408); Osseointegration Problem (3003)

Patient Problems Pain (1994); Deformity/ Disfigurement (2360); Inadequate Osseointegration (2646); No Code Available (3191)

Event Date 09/16/2009

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+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 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).

Manufacturer Narrative

Udi: (b)(4).

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.

• Type of Device: 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
• MDR Text Key: 126179907
• Report Number: 1818910-2018-74559
• Device Sequence Number: 1
• Product Code: JDI
• UDI-Device Identifier: 10603295177821
• UDI-Public: 10603295177821
• Combination Product (y/n): N
• PMA/PMN Number: K851422
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,other
• Type of Report: Initial,Followup,Followup
• Report Date: 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
• Device Operator: Health Professional
• Device Catalogue Number: 563118N
• Device Lot Number: 2385703
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 10/08/2018
• Initial Date FDA Received: 11/05/2018
• Supplement Dates Manufacturer Received: 12/18/2018; 09/23/2019
• Supplement Dates FDA Received: 12/20/2018; 10/21/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 47 YR