MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US SROM 28MM +6 M HEAD; S-ROM FEMORAL HEADS (11/13) : HIP METAL FEMORAL HEADS

Model Number 1365-18-500

Device Problem Device Dislodged or Dislocated (2923)

Patient Problems Wound Dehiscence (1154); Hematoma (1884); Seroma (2069); Joint Dislocation (2374); No Code Available (3191)

Event Date 04/01/2018

Event Type  Injury  

Manufacturer Narrative

(b)(4).Initial reporter occupation: lawyer.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

Event Description

Unf and medical records received.After review of medical records, it was reported that patient had a fall on 31 mar 2018 and had dislocation.Close reduction was not successful.The patient was then revised with diagnosis of dislocation of the left hip replacement, history of acute periprosthetic infection of the left hip replacement and fracture of the greater trochanteric fragment, left hip.Operative notes indicated that after dissecting through the subcutaneous layer, we noticed immediately a large seroma-hematoma.There was partial dehiscence of the fascial closure.Migration of the trochanteric fragment that was previously repaired using non-absorbable sutures.Liner is a competitor.Doi: (b)(6) 2005 (stem); doi: (b)(6) 2018 (head); dor: (b)(6) 2018 (head); left hip.1st revision was captured on (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.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.

• Brand Name: SROM 28MM +6 M HEAD
• Type of Device: S-ROM FEMORAL HEADS (11/13) : HIP METAL FEMORAL HEADS
• Manufacturer (Section D): DEPUY ORTHOPAEDICS INC US; 700 orthopaedic drive; warsaw IN 46581 0988
• MDR Report Key: 9661433
• MDR Text Key: 186397090
• Report Number: 1818910-2020-03789
• Device Sequence Number: 1
• Product Code: JDI
• UDI-Device Identifier: 10603295033165
• UDI-Public: 10603295033165
• Combination Product (y/n): N
• PMA/PMN Number: K851422
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: other
• Type of Report: Initial,Followup
• Report Date: 01/20/2020

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 Expiration Date: 12/31/2020
• Device Model Number: 1365-18-500
• Device Catalogue Number: 136518500
• Device Lot Number: 8248486
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 01/20/2020
• Initial Date FDA Received: 02/03/2020
• Supplement Dates Manufacturer Received: 03/06/2020
• Supplement Dates FDA Received: 03/09/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 55 YR