MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US SROM*STM ST,36+8L NK,24X19X175; S-ROM HIP SYSTEM : HIP FEMORAL STEM

Catalog Number	523424
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	Cyst(s) (1800); Fatigue (1849); Headache (1880); Hearing Impairment (1881); Inflammation (1932); Necrosis (1971); Swelling (2091); Tissue Damage (2104); Injury (2348); Not Applicable (3189); No Code Available (3191)
Date of Event	03/21/2017
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
Pfs and medical records received.Pfs alleges metallosis, fatigue, swelling, inflammation, dislocation, headaches, hearing loss, pseudotumor, necrosis, deterioration and instability of the right hip, gastrointestinal problem, cholecystitis and gallbladder removal.After review of medical records for mdr reportability, the patient was revised to address large pseudotumor causing soft tissue destruction and significant metallosis with cystic changes.Revision notes reported elevated metal ions, aspirated turbid dark black fluid and metallosis within the synovial tissue.The screw was removed and the cup is well fixed.Clinical notes stated that patient previously fell and dislocated and was reduced in er.Mri showed a significant pseudotumor.Doi: (b)(6) 2002; dor: (b)(6) 2017; right hip.
Additional Manufacturer Narrative
Product complaint # = > pc-(b)(4).Investigation summary = > 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.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate. .
Additional 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).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, a follow-up medwatch will be filed as appropriate.

• Common Device Name: S-ROM HIP SYSTEM : HIP FEMORAL STEM
• Manufacturer (Section D): DEPUY ORTHOPAEDICS INC US; 700 orthopaedic drive; warsaw IN 46582 0988
• MDR Report Key: 7402695
• Report Number: 1818910-2018-56838
• Device Sequence Number: 592488
• Product Code: JDI
• UDI-Device Identifier: 10603295171065
• UDI-Public: 10603295171065
• Combination Product (Y/N): N
• Initial Reporter State: AL
• 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: 2017
• Reporter Type: Manufacturer
• Report Source: consumer
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 03/09/2018

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
• Operator of Device: Health Professional
• Device Expiration Date: 10/26/2006
• Device Catalogue Number: 523424
• Device Lot Number: 954128
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 03/09/2018
• Supplement Date Received by Manufacturer: 04/12/2018; 12/11/2019
• Initial Report FDA Received Date: 04/06/2018
• Supplement Report FDA Received Date: 04/19/2018; 01/10/2020
• 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: 52 YR
• Patient Weight: 84