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

Model Number	L20311
Medical Device Problem Code	Migration (4003)
Health Effect - Clinical Codes	Fall (1848); Limb Fracture (4518)
Date of Event	10/08/2021
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
Clinical notification received for revision of right total hip to address periprosthetic femur bone fracture on (b)(6) 2021, right hip was replaced to address end-stage primary arthritis, with reported pain, and difficulties in ambulating and performing activities of daily living.Ingrowth cup and stem components were implanted using a direct anterior approach.There were no reported intraoperative complications.On (b)(6) 2021, the patient experienced a periprosthetic femur fracture, allegedly resulting from having become tangled in her clothes, losing her balance, and subsequently falling to the floor.She was found to have a displaced femur fracture with femoral stem subsidence, which required emergent open reduction internal fixation of her femur.The hip was revised, with placement of a reclaim femoral stem, and reduced with fixation reinforced with placement of an allograft femoral strut splint with four synthes cerclage cables.On (b)(6) 2021, the patient had a right total hip arthroplasty to address primary arthritis, end-stage, right hip.Depuy components, including two dome screws were used during this procedure.On (b)(6) 2021, the patient had a revision right total hip arthroplasty, including open reduction, internal fixation periprosthetic femur fracture, to address right hip periprosthetic femur fracture.The patient fell and sustained a right hip periprosthetic femur fracture, displaced, with subsidence of the stem.Cerclage wire and massive allograft femoral strut graft were used.Date of implantation: (b)(6) 2021, date of revision: (b)(6) 2021, (right hip).Treatment: orif cabling of femur with revision of femoral ste, femoral head, and acetabular liner.
Additional Manufacturer Narrative
Product complaint # (b)(4).Investigation summary : no device associated with this report was received for examination.Provided x-ray images have been reviewed.Although a post revision x-ray image confirms a femoral bone repair has been performed, no images were provided depicting the corail stem associated with this report.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 IN 69801 ; FR 69801
• Manufacturer (Section G): DEPUY FRANCE SAS 3003895575; 7 allee irene joliot curie; b.p. 256; st. priest cedex IN 69801 ; FR 69801
• Manufacturer Contact: kara ditty-bovard ; 700 orthopaedic dr.; warsaw, IN 46581-0988 ; 6107428552
• MDR Report Key: 12737699
• Report Number: 1818910-2021-24164
• Device Sequence Number: 4921065
• 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: 2021
• Device Explanted Year: 2021
• 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
• Report Date (Section B): 10/11/2021

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: L20311
• Device Catalogue Number: L20311
• Device Lot Number: 5353252
• 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: 10/19/2021
• Supplement Date Received by Manufacturer: 11/29/2021
• Initial Report FDA Received Date: 11/02/2021
• Supplement Report FDA Received Date: 11/30/2021
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 10/01/2019
• 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: ALTRX NEUT 36IDX52OD; ARTICULEZE M HEAD 36MM +5; PINN CAN BONE SCREW 6.5MMX20MM; PINN CAN BONE SCREW 6.5MMX30MM; PINNACLE SECTOR II CUP 52MM
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 82 YR
• Patient Sex: Female
• Patient Weight: 64 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White