MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US SROM STM ST,36+6L NK,11X16X150; S-ROM HIP SYSTEM : HIP FEMORAL STEM

Model Number 56-3517

Device Problem Inadequacy of Device Shape and/or Size (1583)

Patient Problems Adhesion(s) (1695); Hematoma (1884); Pain (1994); Scar Tissue (2060); No Code Available (3191)

Event Date 05/29/2008

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

Pinnacle claim form and medical records received.After review of medical records, it was stated that the patient was revised to address instability and recurrent dislocations.The patient was reported to have slipped and fell on (b)(6) 2007 resulting to pain and dislocation.Several incidents of dislocations were reported and were treated with closed reduction.There was also a noted broken screw in the previous reduction; however, it is unknown which specific screw broke.Revision surgery was then opted on (b)(6) 2008.Revision notes reported abundant scar and there was soft tissue laxity and valgus instability.Moreover, during the initial hip replacement on (b)(6) 2007, the srom stem and sleeve were too tight in the bone so the srom stem backed out and femur over reamed to 12mm.A cable was used to avoid insertional fracture.In this course, it resulted to posterior avulsion of the greater trochanter.Later on (b)(6) 2007, an i&d and evacuation of hematoma was done and the avulsion was repaired.Doi: (b)(6) 2007; dor: (b)(6) 2008 right 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.Depuy synthes is submitting this report pursuant to the provisions of 21 cfr, part 803.This report may be based on 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.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

• Brand Name: SROM STM ST,36+6L NK,11X16X150
• Type of Device: S-ROM HIP SYSTEM : HIP FEMORAL STEM
• Manufacturer (Section D): DEPUY ORTHOPAEDICS INC US; 700 orthopaedic drive; warsaw IN 46581 0988
• MDR Report Key: 9699611
• MDR Text Key: 188479595
• Report Number: 1818910-2020-04579
• Device Sequence Number: 1
• Product Code: LPH
• UDI-Device Identifier: 10603295178200
• UDI-Public: 10603295178200
• Combination Product (y/n): N
• PMA/PMN Number: K954935
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,other
• Type of Report: Initial,Followup
• Report Date: 01/27/2020

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: 05/31/2012
• Device Model Number: 56-3517
• Device Catalogue Number: 563517
• Device Lot Number: 2496244
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 01/27/2020
• Initial Date FDA Received: 02/12/2020
• Supplement Dates Manufacturer Received: 03/26/2020
• Supplement Dates FDA Received: 03/26/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 51 YR