MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US S-ROM*SLEEVE PRX ZTT, 14B-SML; S-ROM HIP SYSTEM : HIP FEMORAL SLEEVE

Catalog Number	550501
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Limb Fracture (4518)
Date of Event	09/02/2025
Type of Reportable Event	Serious Injury
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.H11 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.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
It was reported that on (b)(6) 2025, the patient underwent an initial surgery with the products in question.After the surgery on (b)(6) 2025, the breakage of the stem calcar was confirmed.The revision surgery was scheduled on (b)(6) 2025.No further information is 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.Added: d10 concomitant.
Additional Manufacturer Narrative
Product complaint # (b)(4).This report is being submitted pursuant to the provisions of 21 cfr, part 803.This report may be based on information that has not been investigated or verified prior to the required reporting date.This report does not reflect a conclusion by depuy synthes joint reconstruction, or its employees that the report constitutes an admission that the product, depuy synthes joint recon described in this report.H11 additional narrative: added: d9.If information that was not available for the initial report is obtained, a follow-up report will be filed as appropriate.
Additional Manufacturer Narrative
Product complaint # (b)(4).Investigation summary- it was reported that on (b)(6) 2025, the patient underwent an initial surgery with the products in question.After the surgery on (b)(6) 2025, the breakage of the stem calcar was confirmed.The revision surgery was scheduled on sep (b)(6) 2025.No further information is available.The product was returned to depuy synthes for evaluation.Visual analysis of the returned s-rom*sleeve prx ztt, 14b-sml revealed bone ingrowth on the fixation surface.Additionally, marks and scratches were present on the upper section, preventing retrieval of the lot number.A functional test was not performed since it was not applicable to the complaint condition.A dimensional inspection was not performed since it was not applicable to the complaint condition.The overall complaint was not confirmed as the observed condition of the s-rom*sleeve prx ztt, 14b-sml would have not contributed to the reported adverse event.Based on the investigation findings, it has been determined that no corrective and/or preventative action is proposed.There is no indication that a design or manufacturing issue has caused the reported complaint condition.As part of depuy synthes quality process, all devices are manufactured, inspected, and released to approved specifications.Additional monitoring for any potential safety signals will be conducted through complaint trending and other post-market safety surveillance activities.Device history lot- a manufacturing records evaluation (mre) was not performed as no lot number was retrieved for this device due to the condition (scratches) of the returned device.Corrected: h3.

• Common Device Name: S-ROM HIP SYSTEM : HIP FEMORAL SLEEVE
• 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: 23074226
• Report Number: 1818910-2025-16019
• Device Sequence Number: 21348381
• Product Code: LPH
• UDI-Device Identifier: 10603295175179
• UDI-Public: (01)10603295175179
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: P070026
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2025
• Device Explanted Year: 2025
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 09/17/2025

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: 550501
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 09/02/2025
• Supplement Date Received by Manufacturer: 09/23/2025; 11/25/2025; 03/10/2026
• Initial Report FDA Received Date: 09/17/2025
• Supplement Report FDA Received Date: 09/24/2025; 12/01/2025; 03/11/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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: DELTA CER HEAD 9/10 32MM +0; SROM 9/10 14X9X125 30+4
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 55 YR
• Patient Sex: Female
• Patient Weight: 94 KG