MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US SROM*STM ST,36+8L NK,18X13X160; S-ROM HIP SYSTEM : HIP FEMORAL STEM

Catalog Number	523418
Medical Device Problem Codes	Fracture (1260); Migration (4003)
Health Effect - Clinical Codes	Pain (1994); Unspecified Tissue Injury (4559)
Date of Event	12/23/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the doctor did a srom pinnacle total hip on this patient on an unknown date in 2011.This patient did fine until recently when patient began to experience pain.X-rays revealed the srom stem had broken distal at the slot.One of the 2 splines was fractured off of the implant.Doctor revised the hip and explanted the srom sleeve, srom hip ball, srom stem, and pinnacle liner.The hip ball, stem, sleeve, and liner were explanted without too much trouble but it did take approximately 45 minutes to retrieve the broken distal spline from the swim stem.A reclaim modular stem was then implanted with a pin a le dual mobility construct.The patient is a large, active patient.X-rays indicate the stem began to tilt into a varus position which caused the distal tip to impinge on the cortex of the femur.Over time the distal tip of the implant became fatigued and fractured.All pieces were removed from the femur; surgical delay would have been approximately 45minutes to retrieve broken srom stem piece from canal.Doi: 2011, dor: (b)(6) 2024, affected side: left hip.
Additional Manufacturer Narrative
This report is being submitted pursuant to the provisions of 21 cfr, part 803 (and/or part 4, as applicable).This report may be based on information which has not been investigated or verified prior to the required reporting date.This report does not reflect a conclusion by depuy synthes, or its employees that the report constitutes an admission that the product, 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 report, a follow-up report will be filed as appropriate.Additional narrative: d4: udi: as the lot number for the device involved in the event was not provided, the full udi is currently not available.
Additional Manufacturer Narrative
Product complaint # (b)(4).Investigation summary: no device associated with this report was received for examination.An evaluation of the manufacturing record could not be performed as the required product/lot number was not provided to complete the evaluation.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 device lot number is unknown, therefore a¿device history review could not be performed.If the lot/serial number becomes available, the record will be re-assessed.

• 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): JTE WARSAW MFG SITE; 700 orthopaedic drive; warsaw IN 46582
• Manufacturer Contact: kate karberg ; 700 orthopaedic dr.; warsaw, IN 46581 ; 3035526892
• MDR Report Key: 21118128
• Report Number: 1818910-2025-00574
• Device Sequence Number: 7679569
• Product Code: MRA
• UDI-Device Identifier: 10603295171034
• UDI-Public: (01)10603295171034
• Combination Product (Y/N): N
• Initial Reporter State: MI
• Initial Reporter Country: US
• PMA/510(K) Number: P070026
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Explanted Year: 2024
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup

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 Catalogue Number: 523418
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 12/23/2024
• Supplement Date Received by Manufacturer: 01/13/2025
• Initial Report FDA Received Date: 01/09/2025
• Supplement Report FDA Received Date: 01/13/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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+3; ALTRX +4 NEUT 40IDX60OD; S-ROM*SLEEVE PRX ZTT, 18F-LRG
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 65 YR
• Patient Sex: Male
• Patient Weight: 132 KG