MAUDE Adverse Event Report: DEPUY IRELAND 9616671 S-ROM*STM STD,42 NK,18X13X160; S-ROM HIP SYSTEM : HIP FEMORAL STEM

Catalog Number 523393

Device Problem Insufficient Information (3190)

Patient Problems Host-Tissue Reaction (1297); Foreign Body Reaction (1868); Pain (1994); Thrombosis (2100); Weakness (2145); Limited Mobility Of The Implanted Joint (2671)

Event Date 03/08/2012

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

New unity record created in order to update legacy complaint number (b)(4).Litigation alleges that patient experienced hip pain, causing difficulty ambulating and sleeping.Additionally, it is alleged that implant is releasing metal ions into patient's body.Update dec 05, 2017: pfs and medical records received.Pfs also alleges superficial thrombosis, muscle damage requiring surgical repair, metallosis and physical limitations.After review of medical records for mdr reportability, it was stated that the patient was revised to address pain, elevated metal ions and large fluid collections.Revision notes reported no tissue and bone destruction, corrosive black debris, metal staining and minimal fluid staining in the hip.Mri reported greater trochanteric bursitis.Clinic notes reported muscle weakness and stiffness.Added srom sleeve for the reported corrosive black debris.This complaint was updated on: december 15, 2017.Doi: (b)(6) 2010, dor: (b)(6) 2012 (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.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

Manufacturer Narrative

  udi: (b)(4).

• Type of Device: S-ROM HIP SYSTEM : HIP FEMORAL STEM
• Manufacturer (Section D): DEPUY IRELAND 9616671; loughbeg ringaskiddy co.; cork ; EI
• Manufacturer (Section G): JTE WARSAW MFG SITE; 700 orthopaedic drive; warsaw
• Manufacturer Contact: kara ditty-bovard ; 700 orthopaedic drive; warsaw, IN 46581-0988 ; 6103142063
• MDR Report Key: 7159756
• MDR Text Key: 96225156
• Report Number: 1818910-2018-50067
• Device Sequence Number: 1
• Product Code: MRA
• UDI-Device Identifier: 10603295170990
• UDI-Public: 10603295170990
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P070026
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 12/05/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/03/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 04/30/2014
• Device Catalogue Number: 523393
• Device Lot Number: 2887353
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 12/18/2018
• Date Device Manufactured: 04/19/2009
• 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: 27 YR
• Patient Weight: 105