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

Catalog Number	523393
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Codes	Host-Tissue Reaction (1297); Foreign Body Reaction (1868); Pain (1994); Thrombosis (2100); Weakness (2145); Limited Mobility Of The Implanted Joint (2671)
Date of Event	03/08/2012
Type of Reportable Event	Serious Injury
Additional 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 or Problem 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).
Additional 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.
Additional Manufacturer Narrative
udi: (b)(4).

• Common Device Name: S-ROM HIP SYSTEM : HIP FEMORAL STEM
• Manufacturer (Section D): DEPUY IRELAND 9616671; loughbeg ringaskiddy co.; cork ; EI
• MDR Report Key: 7159756
• Report Number: 1818910-2018-50067
• Device Sequence Number: 1274941
• Product Code: MRA
• UDI-Device Identifier: 10603295170990
• UDI-Public: 10603295170990
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Initial Reporter Country: US
• PMA/510(K) Number: P070026
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2010
• Device Explanted Year: 2012
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 12/05/2017

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: 04/30/2014
• Device Catalogue Number: 523393
• Device Lot Number: 2887353
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 12/05/2017
• Supplement Date Received by Manufacturer: 08/28/2018; 12/18/2018
• Initial Report FDA Received Date: 01/03/2018
• Supplement Report FDA Received Date: 09/19/2018; 12/28/2018
• 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: 27 YR
• Patient Weight: 105