MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS, INC. 1818910 S-ROM M HEAD 36MM +0; S-ROM FEMORAL HEADS (11/13) : HIP METAL FEMORAL HEADS

Catalog Number 136531000

Device Problems Material Disintegration (1177); Biocompatibility (2886); Naturally Worn (2988)

Patient Problems Inflammation (1932); Pain (1994); Discomfort (2330); Test Result (2695)

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

Litigation papers allege the following: after the surgery, friction and wear between the cobalt-chromium metal head and cobalt-chromium metal liner caused large amounts of toxic cobalt-chromium metal ions and particles to be released into patient's blood and tissue and bone surrounding the implant.As a result, patient has been experiencing severe pain and discomfort and inflammation in her right thigh and groin.She also experienced a popping and snapping sensation in her hip-joint when walking or moving to and from a sitting position.Doi: (b)(6) 2008 - dor: none reported (right hip).

Manufacturer Narrative

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.Product complaint # (b)(4).No device associated with this report was received for examination.A worldwide complaint database search found no other reported incident(s) against the provided product/lot combination(s) since release for distribution.Based on previous investigations this complication of joint replacement is unlikely to have been the result of a device failing to meet required specifications.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.Corrective action was not indicated.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, a follow-up medwatch will be filed as appropriate.

• Brand Name: S-ROM M HEAD 36MM +0
• Type of Device: S-ROM FEMORAL HEADS (11/13) : HIP METAL FEMORAL HEADS
• Manufacturer (Section D): DEPUY ORTHOPAEDICS, INC. 1818910; 700 orthopaedic drive; warsaw IN 46582 0988
• MDR Report Key: 8013763
• MDR Text Key: 125287216
• Report Number: 1818910-2018-73712
• Device Sequence Number: 1
• Product Code: JDI
• UDI-Device Identifier: 10603295033363
• UDI-Public: 10603295033363
• Combination Product (y/n): N
• PMA/PMN Number: K120599
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,other
• Type of Report: Initial,Followup
• Report Date: 10/04/2018

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 Expiration Date: 03/31/2013
• Device Catalogue Number: 136531000
• Device Lot Number: 2571976
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 10/04/2018
• Initial Date FDA Received: 10/29/2018
• Supplement Dates Manufacturer Received: 04/29/2019
• Supplement Dates FDA Received: 04/29/2019
• Is This a Reprocessed and Reused Single-Use Device?: Yes
• Patient Sequence Number: 1
• Patient Outcome(s): Other