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 Codes	Corroded (1131); Degraded (1153)
Health Effect - Clinical Codes	Adhesion(s) (1695); Edema (1820); Osteolysis (2377); No Code Available (3191)
Date of Event	02/21/2012
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).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
Doi: 2002 - dor: 2006.Patient is a resident of (b)(6).Update (b)(6) 2013) - patient fact sheet was received.The doi and dor have been updated.There is no new information that would change the outcome of the investigation.Update (b)(6) 2019 (b)(4) has been re-opened due to receipt of pcf and medical records.After review of medical records patient was revised to addressed intact acetabular shell and femoral component with marked synovitis right hip, soft tissue degradation.Xrays showed evidence of some progressive osteolysis in the medial wall of the acetabulum, probable of microscopic loosening of the femoral component as per symptoms, tense synovial effusion was encountered.Operative notes indicated upon opening the extensor mechanism, the capsule itself appeared to be tense, a large amount of fluid which appeared to be under pressure, some fibrous and soft tissue type debris scattered throughout it.There was quite a bit corrosion around the taper of the femoral component and there where small amounts of plastic like lining that could be related to fibrous type debris.Added account name, law firm, lawyer, surgeon, medical history, date of implant, stem and product details of liner and head.Corrected date of revision.Doi: (b)(6) 2002, dor: (b)(6) 2004 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 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: 9717518
• Report Number: 1818910-2020-05045
• Device Sequence Number: 19638537
• Product Code: JDI
• UDI-Device Identifier: 10603295170860
• UDI-Public: 10603295170860
• Combination Product (Y/N): N
• Initial Reporter State: IN
• 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: 2004
• Reporter Type: Manufacturer
• Report Source: consumer,other
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 02/21/2012

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?: Yes
• Operator of Device: Health Professional
• Device Model Number: 52-3192
• Device Catalogue Number: 523192
• Device Lot Number: 956022
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 01/31/2020
• Supplement Date Received by Manufacturer: 02/21/2020
• Initial Report FDA Received Date: 02/17/2020
• Supplement Report FDA Received Date: 02/26/2020
• 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: 68 YR