MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US SROM*STM STD,36NK,20X15X165; S-ROM HIP SYSTEM : HIP FEMORAL STEM

Catalog Number	523194
Medical Device Problem Code	Appropriate Device Problem Term/Code Not Available (3191)
Health Effect - Clinical Codes	Pain (1994); Discomfort (2330); Test Result (2695); Not Applicable (3189); No Code Available (3191)
Date of Event	03/23/2015
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
Complaint description: patient was revised to address pain.Update rec'd 5/7/15 - litigation papers received.In addition to what was previously reported, litigation alleges the patient suffers from discomfort.There is no new additional information that would affect the existing mdr decision.Update 8/28/15-pfs and medical records received.After review of the medical records for mdr reportability, the revision operative note indicated pain.There is no new additional information that would affect the existing investigation.The complaint was updated on: (b)(6) 2015.Update ad 1 may 2018: (b)(4) has been re-opened under (b)(6) due to receipt of ppf and sticker sheet records.Ppf alleges elevated metal ions.The event description has been updated to indicate the allegations as reviewed.The law firm name, manufacturing date and udi, and patient harm were updated as well.Doi: (b)(6) 2005; dor: (b)(6) 2005; 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.

• 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: 7552507
• Report Number: 1818910-2018-60778
• Device Sequence Number: 1261675
• Product Code: JDI
• UDI-Device Identifier: 10603295170884
• UDI-Public: 10603295170884
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K851422
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2005
• Device Explanted Year: 2015
• Reporter Type: Manufacturer
• Report Source: consumer,other
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 05/01/2018

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 Catalogue Number: 523194
• Device Lot Number: 1053368
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 05/01/2018
• Supplement Date Received by Manufacturer: 10/23/2018
• Initial Report FDA Received Date: 05/30/2018
• Supplement Report FDA Received Date: 10/24/2018
• 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: 61 YR
• Patient Weight: 59