MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS, INC. 1818910 S-ROM*STM STD,30NK 14X09X130; S-ROM HIP SYSTEM : HIP FEMORAL STEM

Catalog Number	523291
Medical Device Problem Codes	Fracture (1260); Failure to Osseointegrate (1863)
Health Effect - Clinical Codes	Muscle Spasm(s) (1966); Neuropathy (1983); Pain (1994); Inadequate Osseointegration (2646); Fibrosis (3167); No Code Available (3191)
Date of Event	05/16/2008
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.
Event or Problem Description
Pending product liability, pfs alleges pain, neuropathy on the right foot, muscle spasm, and muscle atrophy.After review of medical record, patient was revised to address failed painful right total hip arthroplasty.Revision notes reported that a fair amount of bloody fibrous debris was cultured and debrided.The stem was found to be loose and broken.Intraoperative radiograph showed that perforation had occurred at the lateral cortex, so an eto was performed.A crack was then noted at the distal part of the femur, and two cables were passed distally, and also two proximally, to repair the eto.
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 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: 7966390
• Report Number: 1818910-2018-72542
• Device Sequence Number: 1409283
• Product Code: JDI
• UDI-Device Identifier: 10603295170969
• UDI-Public: 10603295170969
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• PMA/510(K) Number: K851422
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2002
• Device Explanted Year: 2008
• Reporter Type: Manufacturer
• Report Source: consumer,other
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 09/24/2018

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: 523291
• Device Lot Number: 654653
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 09/24/2018
• Supplement Date Received by Manufacturer: 11/07/2018
• Initial Report FDA Received Date: 10/15/2018
• Supplement Report FDA Received Date: 11/08/2018
• 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: 50 YR
• Patient Weight: 88