MAUDE Adverse Event Report: DEPUY INTERNATIONAL LTD - 8010379 CORAIL AMT SZ12 135 HIGH COL; CORAIL LINE EXTENSION IMPLANTS : HIP FEMORAL STEM

Model Number	L971112
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Limb Fracture (4518)
Date of Event	12/06/2022
Type of Reportable Event	Serious Injury
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.
Event or Problem Description
Event details: start date: on (b)(6) 2022.Event day: 0.Alert date: on (b)(6) 2022.Alert time: 04:15 pm.Country of event: can.Adverse event term: possible calcar split.Patient details: patient identifier: (b)(6).Sex: female.Age (at time of consent): 59 years.Additional event details: severity : moderate.Is the adverse event serious? no.Death: no.A life-threatening illness or injury: no a permanent impairment of a body structure or a body function: no required in-patient hospitalization or prolongation of existing hospitalization: no admission date: blank discharge date: blank resulted in medical or surgical intervention to prevent life-threatening illness or injury or permanent impairment to a body structure or a body function: no led to a fetal distress, fetal death or a congenital abnormality or birth defect: no relationship to study device : not related if the event is serious and device or procedure related, according to the definition documented in the protocol and instructions for use, in the opinion of the investigator, is the adverse event expected/anticipated?: n/a (if does not meet above criteria) relationship to primary study procedure : not related relationship to any other protocol: not related outcome : recovering/resolving end date : blank.Did this event result in the subject's discontinuation of the study? no.Intervention/treatment none: no.Medical intervention/modification: no.Diagnostic intervention: no.Culture taken: no.Physical therapy: no.Observation: no.Other: yes.Specify: cerclage wire a.Surgical intervention of the study hip: (select none or all that apply) none: yes.Irrigation & debridement (i&d): no.Arthroscopy: no.Revision: no.Orif: no.Other: no.B.Components removed: (select none or all that apply and complete end of study form).None: yes femoral stem: no femoral head: no acetabular cup: no dual mobility metal.Liner: no dual mobility polyethylene liner: no c.Date of surgical intervention: blank.
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 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.

• Brand Name: CORAIL AMT SZ12 135 HIGH COL
• Common Device Name: CORAIL LINE EXTENSION IMPLANTS : HIP FEMORAL STEM
• Manufacturer (Section D): DEPUY INTERNATIONAL LTD - 8010379; st. anthony's road; leeds LS11 8DT; UK LS11 8DT
• Manufacturer (Section G): DEPUY INT'L LTD. 8010379; st anthonys road; leeds LS11 8 DT; UK LS11 8 DT
• Manufacturer Contact: kate karberg ; 700 orthpaedic dr.; warsaw, IN 46581 ; 3035526892
• MDR Report Key: 16104214
• Report Number: 1818910-2023-00568
• Device Sequence Number: 12671570
• Product Code: MEH
• UDI-Device Identifier: 10603295455318
• UDI-Public: 10603295455318
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K192946
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Study,Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 01/05/2023

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: L971112
• Device Catalogue Number: L971112
• Device Lot Number: 3862279
• 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: 12/19/2022
• Supplement Date Received by Manufacturer: 01/10/2023
• Initial Report FDA Received Date: 01/05/2023
• Supplement Report FDA Received Date: 01/11/2023
• 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
• Concomitant Medical Products and Therapy/Usage Dates: ARTICUL/EZE BALL 22.225+4 NK; BI MENTUM ALTRX LNR 45 22; PINN SECTOR W/GRIPTION 52MM; PINNACLE DM LINER 52_45
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown