MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US SROM STM ST,36+6L NK,11X16X150; S-ROM HIP SYSTEM : HIP FEMORAL STEM

Model Number	56-3517
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	01/22/2021
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 presented to emergency department.Fractured srom stem just below the top of the sleeve - implanted 10 years ago at (b)(6) hospital.The revision surgery has been confirmed as having taken place on (b)(6) 2021.The patient ((b)(6) yo) had to have the stem and the sleeve removed as the surgeon couldn't manage to remove the distal stem on it¿s own.Enough bone remained to use an srom stem for the revision without having to use a distally fixing stem.
Additional Manufacturer Narrative
Product complaint # (b)(4).Investigation summary: no device associated with this report was received for examination.Photographs of the explanted device have been reviewed confirming the reported material fracture.It is not possible however to determine a root cause using photo images.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: the device was implanted approximately 10 years prior a need for revision surgery.It is not suspected any error in device manufacture was the root cause for the problems reported.A manufacturing records evaluation (mre) was not performed.
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.H10 additional narrative:  added: b3, d6b.If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.
Additional Manufacturer Narrative
Product complaint # (b)(4).Investigation summary (b)(6) 2021: the investigation was re-opened upon receipt of additional information.No device associated with this report was received for examination.Visual examination of the provided photographs confirmed the reported fracture and also identified the presence of corrosion.A worldwide complaint database search found no other related reported incidents against the provided product code/lot number combination since release for distribution.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.

• Brand Name: SROM STM ST,36+6L NK,11X16X150
• Common Device Name: S-ROM HIP SYSTEM : HIP FEMORAL STEM
• Manufacturer (Section D): DEPUY ORTHOPAEDICS INC US; 700 orthopaedic drive; warsaw IN 46581 0988
• MDR Report Key: 11285663
• Report Number: 1818910-2021-02161
• Device Sequence Number: 3842258
• Product Code: LPH
• UDI-Device Identifier: 10603295178200
• UDI-Public: 10603295178200
• 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: 2011
• Device Explanted Year: 2021
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 01/19/2021

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: 56-3517
• Device Catalogue Number: 563517
• Device Lot Number: 3247167
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 01/19/2021
• Supplement Date Received by Manufacturer: 01/26/2021; 04/16/2021; 05/18/2021
• Initial Report FDA Received Date: 02/05/2021
• Supplement Report FDA Received Date: 02/12/2021; 04/16/2021; 05/18/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: DELTA CER HEAD 11/13 36MM +0.; EA DELTA CER INSERT 36IDX52OD.; PINN SECTOR HA ACET CUP 52MM.; S-ROM*SLEEVE PRX ZT HA 16F-SML.; DELTA CER HEAD 11/13 36MM +0; EA DELTA CER INSERT 36IDX52OD; PINN SECTOR HA ACET CUP 52MM; S-ROM*SLEEVE PRX ZT HA 16F-SML
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 26 YR