MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US SROM 28MM +0 M HEAD; S-ROM FEMORAL HEADS (11/13) : HIP METAL FEMORAL HEADS

Model Number	1365-16-500
Medical Device Problem Codes	Corroded (1131); Naturally Worn (2988)
Health Effect - Clinical Codes	Edema (1820); Foreign Body Reaction (1868); Hypersensitivity/Allergic reaction (1907); Necrosis (1971); Discomfort (2330); Test Result (2695); No Code Available (3191)
Date of Event	05/02/2016
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Product complaint # (b)(4).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
Unf and medical records received.After review of medical records, patient was revised to address left failed metal-on-metal left total hip arthroplasty with metallosis and abductor muscle necrosis.Patient had elevated metal ion levels and mri consistent with metal-on-metal corrosion and pseudotumor formation.Patient felt discomfort.Upon entering into the joint, the fluid was under tension and had evidence of metal debris.There was evidence of both abductor muscle necrosis and capsular tissue necrosis involving more than 25% of abductor muscles.This was carefully and extensively debrided.He had a small amount of shuck tolerated hip extension and external rotation to about 70 degrees, but the hip dislocated when the hip was flexed to 90 degrees with only 20 degrees of hip internal rotation.The taper and bearing surface of the femoral head had minimal evidence of corrosion.The taper on the stem was in good condition with no evidence of corrosion.Necrotic tissue was removed from around the rim of the acetabulum.There was evidence of corrosion at the taper of the liner acetabular component interface with pseudomembrane formation on the undersurface of the acetabular liner.The acetabular component and femoral component were well fixed.Doi: (b)(6) 2004 - dor: (b)(6) 2016 (left hip).
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.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.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.

• Brand Name: SROM 28MM +0 M HEAD
• Common Device Name: S-ROM FEMORAL HEADS (11/13) : HIP METAL FEMORAL HEADS
• Manufacturer (Section D): DEPUY ORTHOPAEDICS INC US; 700 orthopaedic drive; warsaw IN 46581 0988
• MDR Report Key: 9823504
• Report Number: 1818910-2020-07564
• Device Sequence Number: 11530292
• Product Code: JDI
• UDI-Device Identifier: 10603295033141
• UDI-Public: 10603295033141
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• PMA/510(K) Number: K980513
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2004
• Device Explanted Year: 2016
• Reporter Type: Manufacturer
• Report Source: consumer,other
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 02/24/2020

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 Expiration Date: 02/28/2009
• Device Model Number: 1365-16-500
• Device Catalogue Number: 136516500
• Device Lot Number: 1174790
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 02/24/2020
• Supplement Date Received by Manufacturer: 04/22/2020
• Initial Report FDA Received Date: 03/12/2020
• Supplement Report FDA Received Date: 04/27/2020
• 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: 65 YR