MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US S-ROM M HEAD 36MM+12 NON SKIRT; HIP FEMORAL HEAD

Catalog Number	136536000
Medical Device Problem Codes	Metal Shedding Debris (1804); Insufficient Device Problem Information (3190); Appropriate Device Problem Term/Code Not Available (3191)
Health Effect - Clinical Codes	Host-Tissue Reaction (1297); Inflammation (1932); Pain (1994); Discomfort (2330)
Date of Event	07/07/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
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
Patient was revised to address pain and a small pseudo tumor.
Additional Manufacturer Narrative
No device associated with this report was received for examination.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
Update sep 18, 2017: litigation record received.Litigation alleges friction and wear causing large amounts of toxic metal ions and particles, severe pain, discomfort and inflammation.Added stem due to the alleged toxic metal ions.Added complainant information.This complaint was updated on: oct 16, 2017.
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.
Additional Manufacturer Narrative
(b)(4).

• Brand Name: S-ROM M HEAD 36MM+12 NON SKIRT
• Common Device Name: HIP FEMORAL HEAD
• Manufacturer (Section D): DEPUY ORTHOPAEDICS INC US; 700 orthopaedic drive; warsaw IN 46581 0988
• MDR Report Key: 6764613
• Report Number: 1818910-2017-22213
• Device Sequence Number: 19275345
• Product Code: JDI
• UDI-Device Identifier: 10603295033547
• UDI-Public: 10603295033547
• Combination Product (Y/N): N
• Initial Reporter State: MI
• Initial Reporter Country: US
• PMA/510(K) Number: K120599
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2006
• Device Explanted Year: 2010
• Reporter Type: Manufacturer
• Report Source: consumer,distributor,health p
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date (Section B): 07/07/2017

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 Catalogue Number: 136536000
• Device Lot Number: 1804721B
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 07/07/2017
• Supplement Date Received by Manufacturer: 09/05/2017; 09/18/2017; 09/20/2018; 01/15/2019
• Initial Report FDA Received Date: 08/03/2017
• Supplement Report FDA Received Date: 09/05/2017; 10/17/2017; 09/28/2018; 01/24/2019
• 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: 53 YR
• Patient Weight: 98