MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US S-ROM M HEAD 36MM+12 NON SKIRT; S-ROM FEMORAL HEADS (11/13) : HIP METAL FEMORAL HEADS

Model Number	1365-36-000
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Pain (1994); No Code Available (3191)
Date of Event	11/25/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(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
It was reported that the patient originally had an s-rom femur with a pinnacle metal on metal.The metal on metal was revised and replaced in 2010 but the patients symptoms continued.The patient was revised today to remove the s- rom stem and replace it with a non modular femoral implant.A stem was placed with a ceramic a 40mm ceramic head and 40mm altrex liner.Doi: (b)(6) 2010 (head and liner); stem- unknown doi; dor: (b)(6) 2019; left hip.
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.

• Brand Name: S-ROM M HEAD 36MM+12 NON SKIRT
• 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: 9483385
• Report Number: 1818910-2019-123603
• Device Sequence Number: 459754
• Product Code: JDI
• UDI-Device Identifier: 10603295033547
• UDI-Public: 10603295033547
• Combination Product (Y/N): N
• Initial Reporter State: VT
• Initial Reporter Country: US
• PMA/510(K) Number: K120599
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2010
• Device Explanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 11/25/2019

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 Model Number: 1365-36-000
• Device Catalogue Number: 136536000
• Device Lot Number: 2900938
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 11/25/2019
• Supplement Date Received by Manufacturer: 01/22/2020
• Initial Report FDA Received Date: 12/17/2019
• Supplement Report FDA Received Date: 01/22/2020
• 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: 49 YR
• Patient Weight: 103