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

Catalog Number 523291

Device Problems Disassembly (1168); Migration or Expulsion of Device (1395)

Patient Problem Not Applicable (3189)

Event Date 03/13/2018

Event Type  Injury  

Manufacturer Narrative

If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

Event Description

Srom revision, surgeon: (b)(6) private hospital (b)(6) 2018.Srom revision due to dislocation 5 years after initial surgery.Stem does not seem to have engaged with taper and had come loose.Sleeve well fixed and left in situ.Stem was revised to include a 36 neck option ad poly was exchanged for a 36/52 neutral cup with a 36 head.Patient stable post op.Relevant patient pre-existing conditions/ comorbidities: previous dysplastic hip with pelvic osteotomy.Male patient, (b)(6).Doi:5 years ago; dor: (b)(6) 2018 ; unknown hip.

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.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 ORTHOPAEDIC INC, 1818910; 700 orthopaedic drive; warsaw IN 46582 0988
• Manufacturer (Section G): DEPUY IRELAND 961610; loughbeg ringaskiddy; cork ; EI
• Manufacturer Contact: chad gibson ; 700 orthopaedic drive; warsaw, IN 46582-0988 ; 5743725905
• MDR Report Key: 7412314
• MDR Text Key: 104875871
• Report Number: 1818910-2018-56999
• Device Sequence Number: 1
• Product Code: JDI
• UDI-Device Identifier: 10603295170969
• UDI-Public: 10603295170969
• Combination Product (y/n): N
• Reporter Country Code: AS
• PMA/PMN Number: K851422
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date: 03/13/2018

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?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 523291
• Device Lot Number: 8171563
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/13/2018
• Initial Date FDA Received: 04/10/2018
• Supplement Dates Manufacturer Received: 07/16/2018
• Supplement Dates FDA Received: 08/15/2018
• Date Device Manufactured: 07/02/2015
• 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: 34 YR