MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US S-ROM*STM STD,36NK,16X11X150; S-ROM HIP SYSTEM : HIP FEMORAL STEM

Model Number	52-3192
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Cyst(s) (1800); Foreign Body Reaction (1868); Hypersensitivity/Allergic reaction (1907); Necrosis (1971); Test Result (2695); No Code Available (3191)
Date of Event	09/10/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).Initial reporter occupation: lawyer.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
Pcf and medical records received.After review of medical records patient was revised to addressed failed right total hip arthroplasty secondary to metal on metal tissue reaction, metallosis, suspected pseudotumor and resultant instability.Operative notes indicated extensive metal on metal wear debris extending through chronic disruption of the anterior superior aspect of gluteus medius on the greater trochanter with softening of the bone and extensive metal debris.Having spontaneous dislocations of the hip last several months, persistent limp since then.No evidence of infection but significantly elevated cobalt and chromium level.Anterior pseudocapsule was excised indicating no evidence of inflammation and no evidence of infection.Cup was a bit on the vertical and enteverted side.One screw in the acetabular shell itself was backed out and the cup is well fixed.Doi: (b)(6) 2010, dor: (b)(6) 2018 right hip.
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.Device history lot : null device history batch : null device history review : null 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: 9740963
• Report Number: 1818910-2020-05682
• Device Sequence Number: 14053816
• Product Code: JDI
• UDI-Device Identifier: 10603295170860
• UDI-Public: 10603295170860
• Combination Product (Y/N): N
• Initial Reporter State: MI
• Initial Reporter Country: US
• PMA/510(K) Number: K851422
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2010
• Reporter Type: Manufacturer
• Report Source: consumer,other
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 02/05/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 08/31/2015
• Device Model Number: 52-3192
• Device Catalogue Number: 523192
• Device Lot Number: 3185710
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 02/05/2020
• Supplement Date Received by Manufacturer: 03/30/2020
• Initial Report FDA Received Date: 02/21/2020
• Supplement Report FDA Received Date: 03/31/2020
• 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: 59 YR