MAUDE Adverse Event Report: DEPUY IRELAND - 9616671 CORAIL AMT SZ12 LOW COL

Model Number	L971312
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Limb Fracture (4518)
Date of Event	05/17/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that on (b)(6) 2023, the primary surgery was performed via bha with the product in question.The surgery was completed successfully without any surgical delay.On an unknown date, when the patient went to see the doctor complaining of pain, dislocation was found.Manual repair was performed, but the shortening seemed to have progressed and resulted in a femur fracture.The revision surgery was performed on (b)(6) 2023.The surgeon removed the stem which was not stable enough.He fixed the affected area with a plate and cable and cemented a k-wire and inserted it as an intramedullary nail finishing the surgery as girdlestone.He commented that there would be no causal relationship with the implant and it may be due to the characteristics of the patient.No further information is available.Doi: (b)(6) 2023.Dor: (b)(6) 2023.Affected side: unknown.
Additional Manufacturer Narrative
Product complaint #: (b)(4).H6 component code: appropriate term/code not available (g07002) used to capture no findings available.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.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.

• Brand Name: CORAIL AMT SZ12 LOW COL
• Common Device Name: CORAIL AMT SZ12 LOW COL
• Manufacturer (Section D): DEPUY IRELAND - 9616671; loughbeg ringaskiddy co.; cork ; EI
• Manufacturer (Section G): DEPUY IRELAND 9616671; loughbeg, ringaskiddy co.; cork IN ; EI
• Manufacturer Contact: kate karberg ; 700 orthopaedic dr.; warsaw, IN 46581-0988 ; 3035526892
• MDR Report Key: 17010599
• Report Number: 1818910-2023-11062
• Device Sequence Number: 18051592
• Product Code: MEH
• UDI-Device Identifier: 10603295478690
• UDI-Public: 10603295478690
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K213839
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2023
• Device Explanted Year: 2023
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 05/26/2023

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 Model Number: L971312
• Device Catalogue Number: L971312
• 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: 05/16/2023
• Initial Report FDA Received Date: 05/26/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 55 YR
• Patient Sex: Female