MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US S-ROM*STM STD,36NK,14X09X130; HIP FEMORAL STEM/SLEEVE

Catalog Number	523191
Medical Device Problem Codes	Adverse Event Without Identified Device or Use Problem (2993); Appropriate Device Problem Term/Code Not Available (3191)
Health Effect - Clinical Codes	Pain (1994); Tissue Damage (2104); Discomfort (2330); Ambulation or Postural Difficulties (2544); Limited Mobility Of The Implanted Joint (2671)
Date of Event	03/06/2014
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.
Event or Problem Description
Litigation alleges the patient suffers from pain, discomfort and toxic cobalt-chromium metal ions and particles to be released into the blood, tissue and bone.Update: (b)(6) 2017: pfs and medical records received.In addition to what was previously alleged.Pfs alleges aches, swelling, clicking and inability to walk, pick, bend, lift and cross legs for a long period of time.It was added that there was limitation and injuries.After review of medical records for the mdr reportability, patient was revised to address painful right total hip arthroplasty with significant inflammatory synovitis.Revision notes reported of no new allegation.This complaint was updated on (b)(6) 2017.
Additional Manufacturer Narrative
(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.
Additional Manufacturer Narrative
(b)(4).
Event or Problem Description
Ppf alleges metal wear.
Additional 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.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.

• Common Device Name: HIP FEMORAL STEM/SLEEVE
• Manufacturer (Section D): DEPUY ORTHOPAEDICS INC US; 700 orthopaedic drive; warsaw IN 46581 0988
• MDR Report Key: 7053469
• Report Number: 1818910-2017-29583
• Device Sequence Number: 2144618
• Product Code: JDI
• UDI-Device Identifier: 10603295170853
• UDI-Public: 10603295170853
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• PMA/510(K) Number: K851422
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2002
• Device Explanted Year: 2003
• Reporter Type: Manufacturer
• Report Source: consumer,other
• Initial Reporter Occupation: Attorney
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 10/26/2017

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
• Operator of Device: Health Professional
• Device Expiration Date: 08/31/2006
• Device Catalogue Number: 523191
• Device Lot Number: 932858
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 10/26/2017
• Supplement Date Received by Manufacturer: 09/10/2018; 12/27/2018; 11/11/2019
• Initial Report FDA Received Date: 11/22/2017
• Supplement Report FDA Received Date: 09/21/2018; 01/01/2019; 11/11/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 49 YR
• Patient Weight: 61