MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US 11/13 S-ROM 40MM M SPEC+9; S-ROM FEMORAL HEADS (11/13) : HIP METAL FEMORAL HEADS

Model Number	1365-45-500
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Death (1802); Hematoma (1884); Hemorrhage/Blood Loss/Bleeding (1888)
Date of Event	10/01/2020
Type of Reportable Event	Death
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
Clinical adverse event received for death, secondary to possible gastrointestinal bleed event serious and is considered severe/fatal.Event is definitely not related to device and is remote possibility related to procedure.Date of implantation: (b)(6) 2014.Date of revision (non-study hip): (b)(6) 2020.Date of event (onset): october 2020 (day unknown).(right hip).Treatment: none.
Additional Manufacturer Narrative
Product complaint # (b)(4).Investigation summary - no device associated with this report was received for examination.A review of the provided x-ray images finds no indication of a product problem.As indicated by the complainant the report is not suspected to be device related.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: 11/13 S-ROM 40MM M SPEC+9
• 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: 10838265
• Report Number: 1818910-2020-24626
• Device Sequence Number: 3644795
• Product Code: JDI
• UDI-Device Identifier: 10603295033851
• UDI-Public: 10603295033851
• Combination Product (Y/N): N
• Initial Reporter State: CO
• Initial Reporter Country: US
• PMA/510(K) Number: K060031
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: health professional,study
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 10/30/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Model Number: 1365-45-500
• Device Catalogue Number: 136545500
• Device Lot Number: 9423108
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 10/30/2020
• Supplement Date Received by Manufacturer: 12/10/2020
• Initial Report FDA Received Date: 11/13/2020
• Supplement Report FDA Received Date: 12/15/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: 11/13 S-ROM 40MM M SPEC+9.; ALTRX +4 NEUT 40IDX56OD.; APEX HOLE ELIM POSITIVE STOP.; PINNACLE 100 ACET CUP 56MM.; S-ROM*SLEEVE PRX ZTT, 20F-.; SROM*STM ST,36+8L NK,20X15X165.; 11/13 S-ROM 40MM M SPEC+9; ALTRX +4 NEUT 40IDX56OD; APEX HOLE ELIM POSITIVE STOP; PINNACLE 100 ACET CUP 56MM; S-ROM*SLEEVE PRX ZTT, 20F-SML; SROM*STM ST,36+8L NK,20X15X165
• Outcome Attributed to Adverse Event: Death
• Patient Age: 61 YR
• Patient Weight: 102