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

Catalog Number 523291

Device Problems Fracture (1260); Failure to Osseointegrate (1863)

Patient Problems Muscle Spasm(s) (1966); Neuropathy (1983); Pain (1994); Inadequate Osseointegration (2646); Fibrosis (3167); No Code Available (3191)

Event Date 05/16/2008

Event Type  Injury  

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 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.

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.

• Type of Device: S-ROM HIP SYSTEM : HIP FEMORAL STEM
• Manufacturer (Section D): DEPUY ORTHOPAEDICS, INC. 1818910; 700 orthopaedic drive; warsaw IN 46582 0988
• Manufacturer (Section G): DEPUY ORTHOPAEDICS, INC. 1818910; 700 orthopaedic drive; warsaw IN 46582 0988
• Manufacturer Contact: chad gibson ; 700 orthopaedic drive; warsaw, IN 46582-0988 ; 5743725905
• MDR Report Key: 7966390
• MDR Text Key: 123737406
• Report Number: 1818910-2018-72542
• Device Sequence Number: 1
• Product Code: JDI
• UDI-Device Identifier: 10603295170969
• UDI-Public: 10603295170969
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K851422
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,other
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 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
• Device Operator: Health Professional
• Device Catalogue Number: 523291
• Device Lot Number: 654653
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 09/24/2018
• Initial Date FDA Received: 10/15/2018
• Supplement Dates Manufacturer Received: 11/07/2018
• Supplement Dates FDA Received: 11/08/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 50 YR
• Patient Weight: 88