MAUDE Adverse Event Report: DEPUY FRANCE SAS 3003895575 CORAIL2 NON COL HO SIZE 11; HIP FEMORAL STEM

Model Number	L20311
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Limb Fracture (4518)
Date of Event	05/02/2022
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
Clinical adverse event received for intra-op periprosthetic fracture - femoral.Event is serious and is considered mild.Event is possibly related to both device and procedure.Date of implant: (b)(6) 2022; date of event: (b)(6) 2022; (right hip).Treatment: intra-op open reduction internal fixation.
Additional Manufacturer Narrative
Product complaint # (b)(4).Investigation summary device associated with this report was not received for examination.All implant x-ray images were reviewed.A femur fracture can be observed.However, no evidence of implant fracture, disassociation, or anything indicative of a device nonconformance was found.Depuy synthes considers the investigation closed at this time.Should additional information be received, the information will be reviewed, and the investigation may 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: CORAIL2 NON COL HO SIZE 11
• Common Device Name: HIP FEMORAL STEM
• Manufacturer (Section D): DEPUY FRANCE SAS 3003895575; 7 allee irene joliot curie; b.p. 256; st. priest cedex 69801 ; FR 69801
• Manufacturer (Section G): DEPUY FRANCE SAS 3003895575; 7 allee irene joliot curie; b.p. 256; st. priest cedex 69801 ; FR 69801
• Manufacturer Contact: kate karberg ; 700 orthopaedic dr.; warsaw, IN 46581-0988 ; 3035526892
• MDR Report Key: 14487603
• Report Number: 1818910-2022-09523
• Device Sequence Number: 20123945
• Product Code: LZO
• UDI-Device Identifier: 10603295258025
• UDI-Public: 10603295258025
• Combination Product (Y/N): N
• Initial Reporter State: CO
• Initial Reporter Country: US
• PMA/510(K) Number: K190344
• 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: Study,Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 05/24/2022

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: L20311
• Device Catalogue Number: L20311
• Device Lot Number: 5350486
• 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: 05/06/2022
• Supplement Date Received by Manufacturer: 06/21/2022; 06/23/2022
• Initial Report FDA Received Date: 05/24/2022
• Supplement Report FDA Received Date: 06/22/2022; 06/24/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 09/01/2019
• 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: ARTICULEZE M HEAD 36MM +5; CORAIL2 NON COL HO SIZE 11; PINN CAN BONE SCREW 6.5MMX20MM; PINN CAN BONE SCREW 6.5MMX25MM; PINN MAR +4 NEUT 36IDX54OD; PINNACLE SECTOR II CUP 54MM
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 72 YR
• Patient Sex: Female
• Patient Weight: 68 KG