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

Catalog Number	523192
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Foreign Body Reaction (1868); Hemorrhage/Blood Loss/Bleeding (1888); Hypersensitivity/Allergic reaction (1907); Inflammation (1932); Pain (1994); Tissue Damage (2104); Weakness (2145); Discomfort (2330); Limited Mobility Of The Implanted Joint (2671); Test Result (2695); No Code Available (3191)
Date of Event	08/23/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Product complaint # (b)(4).Initial reporter occupation: lawyer.(b)(4).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
Pinnacle claim submission form and medical records received.After review of medical records, the patient was revised to address dislocation, clicking, discomfort, bilateral lower extremity foot drop, pain, elevated blood metal ions and metal on metal reaction.Patient had stated that she felt that her hip has subluxed at times.Range of motion was noted to be limited.There was tenderness and weakness as well.Intraoperative findings include metallosis with "dish soap water fluid", a significantly abducted acetabular component and gross trunnionosis on the femoral head.During the revision surgery, patient had acute blood loss anemia secondary to the surgery.Two packed red blood cells were given.Doi: (b)(6) 2008.Dor: (b)(6) 2017.(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.A worldwide complaint database search found no other related reported incidents against the provided product code/lot number combination since release for distribution.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.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: 9110263
• Report Number: 1818910-2019-105939
• Device Sequence Number: 2862678
• Product Code: JDI
• UDI-Device Identifier: 10603295170860
• UDI-Public: 10603295170860
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K851422
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2008
• Device Explanted Year: 2017
• Reporter Type: Manufacturer
• Report Source: other
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 09/03/2019

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: 523192
• Device Lot Number: 2514418
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 09/03/2019
• Supplement Date Received by Manufacturer: 10/22/2019
• Initial Report FDA Received Date: 09/24/2019
• Supplement Report FDA Received Date: 10/30/2019
• 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: 48 YR
• Patient Weight: 82