MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US SROM STM STD 36+12L 15X20; S-ROM HIP SYSTEM : HIP FEMORAL STEM

Model Number	56-3620
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Unspecified Infection (1930)
Date of Event	03/01/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Product complaint #(b)(4).H6 component code: appropriate term/code not available (g07002) used to capture no findings available.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.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.
Event or Problem Description
Clinical adverse event received for deep infection.Event is serious and is considered moderate.Event is possibly related to both device and procedure.Date of implant: (b)(6) 2020 date of event: (b)(6) 2023 (left hip).Treatment: plan to explant, administer antibiotics for 6 weeks, and re-plant.No intervention as been initiated.Depuy components used (no revision completed):.
Event or Problem Description
A clinical notification update indicates a revision was completed on (b)(6) 2024 to address infection.The stem, head, liner, and cup were removed.
Additional Manufacturer Narrative
Product complaint # (b)(4).Investigation summary : update apr 7, 2024.No device associated with this report was received for examination.A search of the depuy nonconformance (nc) quality system found no nc¿s associated with this product< 563620>/lot<9282301> combination.As part of our company quality system process, all devices are manufactured, inspected, and distributed to approved specifications.Additional complaint information monitoring for potential safety signals will be conducted through complaint trending as part of the post-market surveillance.If additional information is made available, the investigation will be updated as applicable.Device history lot : the product investigation found no evidence suspecting an error in the manufacturing or material that would be a contributing factor in the reported allegation(s).A manufacturing records evaluation (mre) was not performed.A search of the depuy nonconformance (nc) quality system found no nc¿s associated with this product< 563620>/lot<9282301> combination.

• Brand Name: SROM STM STD 36+12L 15X20
• Common Device Name: S-ROM HIP SYSTEM : HIP FEMORAL STEM
• 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 orthopaedic dr.; warsaw, IN 46581-0988 ; 3035526892
• MDR Report Key: 16817075
• Report Number: 1818910-2023-08772
• Device Sequence Number: 1943159
• Product Code: JDI
• UDI-Device Identifier: 10603295178231
• UDI-Public: 10603295178231
• Combination Product (Y/N): N
• Initial Reporter State: CO
• Initial Reporter Country: US
• PMA/510(K) Number: P070026
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Device Explanted Year: 2024
• 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): 04/26/2023

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?: No
• Operator of Device: Health Professional
• Device Model Number: 56-3620
• Device Catalogue Number: 563620
• Device Lot Number: 9282301
• 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: 04/14/2023
• Supplement Date Received by Manufacturer: 04/07/2024
• Initial Report FDA Received Date: 04/26/2023
• Supplement Report FDA Received Date: 04/08/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 09/16/2019
• 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: ALTRX +4 NEUT 36IDX54OD; DELTA CER HEAD 11/13 36MM +3; PINN CAN BONE SCREW 6.5MMX20MM; PINN CAN BONE SCREW 6.5MMX25MM; PINNACLE SECTOR II CUP 54MM; S-ROM*SLEEVE PRX ZTT, 20D-SML; SROM STM STD 36+12L 15X20
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 59 YR
• Patient Sex: Male
• Patient Weight: 118 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White