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

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Death (1802); Hematoma (1884); Hemorrhage/Bleeding (1888)

Event Date 10/01/2020

Event Type  Death  

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 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.

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
• Type of Device: 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
• MDR Text Key: 216193532
• Report Number: 1818910-2020-24626
• Device Sequence Number: 1
• Product Code: JDI
• UDI-Device Identifier: 10603295033851
• UDI-Public: 10603295033851
• Combination Product (y/n): N
• PMA/PMN Number: K060031
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,study
• Type of Report: Initial,Followup
• Report Date: 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
• Device Operator: Health Professional
• Device Model Number: 1365-45-500
• Device Catalogue Number: 136545500
• Device Lot Number: 9423108
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 10/30/2020
• Initial Date FDA Received: 11/13/2020
• Supplement Dates Manufacturer Received: 12/10/2020
• Supplement Dates FDA Received: 12/15/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: 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
• Patient Outcome(s): Death
• Patient Age: 61 YR
• Patient Weight: 102