MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS, INC. 1818910 S-ROM M HEAD 36MM+12 NON SKIRT; HIP METAL FEMORAL HEADS

Model Number	1365-36-000
Medical Device Problem Codes	Naturally Worn (2988); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Host-Tissue Reaction (1297); Arthritis (1723); Fall (1848); Foreign Body Reaction (1868); Inflammation (1932); Pain (1994); Synovitis (2094); Weakness (2145); Joint Disorder (2373); Fibrosis (3167); No Code Available (3191)
Date of Event	11/01/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Product complaint # (b)(4).
Event or Problem Description
Patient was revised to address pain.
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.
Event or Problem Description
After review of medical records, the patient was revised to address pain, instability and leg length offset reduction.Operative note reported metallosis with metal staining of synovial tissues, cup placement with minimal bone with malunion creating anterior impingement.The cup was left in situ to prevent pelvic discontinuity.Surgical pathology reported fibrosynovial tissue with aggregates of histiocytes with yellow-brown metal debris and focal mild chronic inflammation and alval.Fibrosis due to internal prosthetic device.Doi: (b)(6) 2007; dor: (b)(6) 2017; right hip (second revision).
Additional Manufacturer Narrative
Depuy synthes is submitting this report pursuant to the provision of 21 cfr, part 803.The report may be based on the 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.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.
Additional Manufacturer Narrative
Product complaint #: (b)(4).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.  h10 additional narrative:  added: b5; b6; b7; h6 (patient code).H6 patient code: no code available (3191) used to capture (medical device removal).
Event or Problem Description
After review of medical records, patient was revised to address painful revision right total hip arthroplasty with metal on metal articulation.Revision note reported metalosis with metal staining of synovial tissues but no significant evidence of osteolysis; minimal bone anteriorly and overhanging anterior inferior iliac spine with malunion and anterolateral zone distal to the acetabular component creating anterior impingement, and no evidence of advanced metalosis, no evidence of bony osteolysis or soft tissue erosion, and it was also indicated of instability with metal on metal articulation.Operative note reported there was metalosis throughout the joint but this was not severe, there was metal staining of the synovial tissues but no evidence of osteolysis, there was no evidence of significant muscle damage or myonecrosis.
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.H10 additional 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.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.

• Brand Name: S-ROM M HEAD 36MM+12 NON SKIRT
• Common Device Name: HIP METAL FEMORAL HEADS
• Manufacturer (Section D): DEPUY ORTHOPAEDICS, INC. 1818910; 700 orthopaedic drive; warsaw IN 46582 0988
• MDR Report Key: 7070159
• Report Number: 1818910-2017-50371
• Device Sequence Number: 944447
• Product Code: JDI
• UDI-Device Identifier: 10603295033547
• UDI-Public: 10603295033547
• Combination Product (Y/N): N
• Initial Reporter State: NC
• Initial Reporter Country: US
• PMA/510(K) Number: K120599
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2007
• Device Explanted Year: 2017
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Health Professional
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date (Section B): 11/01/2017

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 Expiration Date: 11/30/2009
• Device Model Number: 1365-36-000
• Device Catalogue Number: 136536000
• Device Lot Number: 1826219
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 11/01/2017
• Supplement Date Received by Manufacturer: 04/19/2018; 04/10/2019; 07/29/2019; 12/27/2019; 01/24/2020
• Initial Report FDA Received Date: 11/30/2017
• Supplement Report FDA Received Date: 04/20/2018; 04/30/2019; 07/30/2019; 01/02/2020; 01/29/2020
• 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: 27 YR