MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US SROM*STM LG 36+8L 18X13X215N; S-ROM HIP SYSTEM : HIP FEMORAL STEM

Model Number	56-3118N
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	06/18/2015
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Product complaint # (b)(4).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
Patient has had several revisions in the past 20 years.Most recent revision completed due to instability.It was discovered during surgery that the srom femal stem fractured.A piece of the stem was left behind in the femoral canal.Surgeon exchanged the femoral head and removed the esca alumina ceramic acetabular bearing that was original from the primary surgery.A constrained liner was implanted.Primary surgery - right hip; approximately 20 years ago - details unknown.Esca hip implanted (no depuy products involved).Revision 1: *revision of esca products* (b)(6) 2009, (b)(6) hospital, dr.(b)(6).Usage: 563118n, srom*stm lg 36+8l 18x13x215n, 2783353; 550727, s-rom*slve zttovsz 20f-sml18id, 2785308; 528323, s-rom*head femrl alumina 32+0, 2224752.Revision 2 ((b)(4)- current pc).*revision of depuy products - esca products left in situ* (b)(6) 2015, (b)(6) hospital, dr.(b)(6).Usage: 523420, s-rom stm st 36+8l nk 20x15x16, 7774624; 550738, s-rom sleeve zttovsz 22f-lrg20id, 3200641; 136532210, delta cer head 11/13 32mm +0, 8042154.Revision right hip (b)(4).*revision of both esca and depuy products* (b)(6) 2022, (b)(6) hospital, dr.(b)(6).Usage: 522028, s-rom head femoral cocr 28+0, 9308200.
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).This report is being submitted pursuant to the provisions of 21 cfr, part 803.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 joint reconstruction, or its employees that the report constitutes an admission that the product, depuy synthes joint reconstruction, 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.
Event or Problem Description
Please confirm if the srom stem was the only fractured component in this event.As per the event description; the srom stem was the only fractured component in this event.
Additional Manufacturer Narrative
Product complaint # (b)(4).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.Device history lot a manufacturing record evaluation was performed for the finished device (b)(4) and lot 2783353, and no non-conformances / manufacturing irregularities were identified.

• 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: kara ditty-bovard ; 700 orthopaedic dr.; warsaw, IN 46581-0988 ; 6107428552
• MDR Report Key: 13930428
• Report Number: 1818910-2022-05657
• Device Sequence Number: 12325008
• Product Code: LWJ
• UDI-Device Identifier: 10603295177821
• UDI-Public: 10603295177821
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: P070026
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2009
• Device Explanted Year: 2015
• 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): 03/28/2022

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: 56-3118N
• Device Catalogue Number: 563118N
• Device Lot Number: 2783353
• 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: 03/10/2022
• Supplement Date Received by Manufacturer: 05/09/2022; 06/06/2022; 06/16/2022
• Initial Report FDA Received Date: 03/28/2022
• Supplement Report FDA Received Date: 05/11/2022; 06/09/2022; 06/17/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 11/19/2008
• 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: S-ROM*SLVE ZTTOVSZ 20F-SML18ID; UNK HIP FEMORAL HEAD METAL SROM
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 57 YR
• Patient Sex: Male