MAUDE Adverse Event Report: DEPUY IRELAND - 3015516266 EMSYS STEM CLRD HO 7; HIP IMPLANT FEMORAL STEM

Catalog Number	474207200
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Limb Fracture (4518)
Date of Event	09/11/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
Subject id: (b)(6).Study no: dots.Clinical adverse event received for periprosthetic fracture - femoral.Device related: definitely not.Procedure related: possibly.Date of event: september 11, 2024.Date of implant: information not provided.Date of revision: information not provided.Device location: right.Treatment/impact: no information provided.
Additional Manufacturer Narrative
Product complaint # (b)(4).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 Manufacturer Narrative
Product complaint # (b)(4).Investigation summary: no device associated with this report was received for examination.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 records evaluation (mre) was not perform.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.
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: b5 corrected: h6 (impact code).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
Additional information was received: this was a primary hip surgery with fx of his trochanter post op with no treatment.Clinic visit on (b)(6) 2024 states the patient was 6 weeks out from a primary tha that was performed to treat avn.The surgeon states, "6 years" but it can be assumed this is an error as this is a post-op visit.The patient sustained a trochanteric fracture intraoperatively but there is no indication what the treatment was.Xrays confirm there is a fracture that is minimally displaced.The patient is stated to be doing well and currently in rehab.*because it is noted that the fracture occurred intraoperatively, it can be assumed that implant date and event date should be (b)(6) which is 6 weeks prior to the clinic visit.

• Brand Name: EMSYS STEM CLRD HO 7
• Common Device Name: HIP IMPLANT FEMORAL STEM
• Manufacturer (Section D): DEPUY IRELAND - 3015516266; loughbeg ringaskiddy co.; cork ; EI
• Manufacturer (Section G): CORK MFG & MATERIAL WAREHOUSE; loughbeg ringaskiddy; cork ; EI
• Manufacturer Contact: kate karberg ; 700 orthopaedic dr.; warsaw, IN 46581-0988 ; 3035526892
• MDR Report Key: 20291393
• Report Number: 1818910-2024-20047
• Device Sequence Number: 7995945
• Product Code: MEH
• UDI-Device Identifier: 10603295505570
• UDI-Public: (01)10603295505570(17)290430(10)4463887
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K211657
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Study
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 09/24/2024

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 Catalogue Number: 474207200
• Device Lot Number: 4463887
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 09/13/2024
• Supplement Date Received by Manufacturer: 10/03/2024; 10/11/2024
• Initial Report FDA Received Date: 09/24/2024
• Supplement Report FDA Received Date: 10/07/2024; 10/21/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 05/21/2024
• 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: 12/14 ARTICUL 40MM M SPEC+5; EMSYS LNR AOX +4N 56-58X40; EMSYS SHL 3HOLE 58; PINN CAN BONE SCREW 6.5MMX20MM; PINN CAN BONE SCREW 6.5MMX25MM; PINN CAN BONE SCREW 6.5MMX35MM
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 73 YR
• Patient Sex: Male