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	Unspecified Infection (1930); Fluid Discharge (2686)
Date of Event	02/21/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
Clinical notification received for revision due to infection.Date of implant: (b)(6) 2022.Date of revision: (b)(6) 2023.(right hip).Treatment: revision; stem and head were revised.
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.
Additional Manufacturer Narrative
Product complaint # (b)(4).Information was received indicating that "while removing the acetabular cup, there was a noted acetabular posterior fracture.As this fracture occurred during extraction of the cup - it will not be reported as the cup is intended to become ingrown." due to this, depuy synthes joint reconstruction considers the device on this report to be not reportable as there is no allegation of deficiency or patient harm, additional follow up is being conducted.Further updates will only be provided if additional information is received that changes the regulatory determination.

• 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
• Manufacturer (Section G): DEPUY IRELAND 9616671; loughbeg, ringaskiddy co.; cork ; EI
• Manufacturer Contact: kate karberg ; 700 orthpaedic dr.; warsaw, IN 46581 ; 3035526892
• MDR Report Key: 16522584
• Report Number: 1818910-2023-05573
• Device Sequence Number: 17757003
• Product Code: LPH
• 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: 2022
• Device Explanted Year: 2023
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Study,Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 03/10/2023

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 Model Number: 1365-45-500
• Device Catalogue Number: 136545500
• Device Lot Number: 9489108
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/22/2023
• Supplement Date Received by Manufacturer: 03/06/2023
• Initial Report FDA Received Date: 03/10/2023
• Supplement Report FDA Received Date: 03/17/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 04/15/2020
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: 11/13 S-ROM 40MM M SPEC+9; ALTRX +4 10D 40IDX58OD; PINN CAN BONE SCREW 6.5MMX20MM; PINN CAN BONE SCREW 6.5MMX20MM; PINN CAN BONE SCREW 6.5MMX20MM; PINN REVISION W/GRIPTION 64MM; PINNACLE BONE SCREW 50 MM
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 73 YR
• Patient Sex: Female
• Patient Weight: 94 KG
• Patient Ethnicity: Hispanic
• Patient Race: White