MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US S-ROM*STM STD,42 NK,20X15X165; S-ROM HIP SYSTEM : HIP FEMORAL STEM

Catalog Number	523394
Medical Device Problem Codes	Biocompatibility (2886); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Inflammation (1932); Pain (1994); Tissue Damage (2104); Discomfort (2330); Osteolysis (2377); Test Result (2695); No Code Available (3191)
Date of Event	08/22/2012
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Product complaint # (b)(4).If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.(b)(4).This report is for an unknown.Occupation: attorney.
Event or Problem Description
New (b)(4) record created in order to update (b)(4) (legacy system) complaint number (b)(4).Reason for original complaint.Patient was revised to address metalosis, osteolysis, and pain.Update: litigation papers received 12/4/2013.Litigation alleges that the patient suffers from discomfort and inflammation.Update 1/28/2015 - disc 208 pfs and medical records received.Pfs identified patient height.There is no new additional information that would affect the existing mdr decision.Update ad 17 jul 2018 -receipt of ppf and sticker sheets.Ppf alleges pseudotumor, metal wear and elevated metal ions.
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, 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 46581 0988
• MDR Report Key: 8469035
• Report Number: 1818910-2019-89126
• Device Sequence Number: 13824590
• Product Code: JDI
• UDI-Device Identifier: 10603295171003
• UDI-Public: 10603295171003
• 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: 2004
• Device Explanted Year: 2012
• Reporter Type: Manufacturer
• Report Source: consumer,other
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 03/11/2019

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: 523394
• Device Lot Number: 1067411
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 03/11/2019
• Supplement Date Received by Manufacturer: 11/22/2019
• Initial Report FDA Received Date: 04/01/2019
• Supplement Report FDA Received Date: 12/05/2019
• 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: 76 YR
• Patient Weight: 86