MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US CORAIL2 LAT COXA VARA SIZE 14; CORAIL AMT CEMENTLESS IMPLANT : HIP FEMORAL STEM

Model Number	3L93714
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Limb Fracture (4518)
Date of Event	06/01/2021
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 adverse event received for trochanter periprosthetic fracture - femoral.Event is serious and is considered mild.Event is possibly related to both device and procedure.Date of implantation: (b)(6) 2021, date of event (onset): (b)(6) 2021; (right hip).Treatment: orif.
Event or Problem Description
On (b)(6) 2021, the patient had a right total hip arthroplasty to address osteoarthritis, end-stage.Depuy components, including 2 screws were used during the procedure.During the procedure the surgeon reported having some fragmentation of the trochanter.The surgeon felt that the hip was stable, but because of the fragmentation, the patient will avoid active abduction postoperatively.On (b)(6) 2021 patient is experiencing thigh pain and limp status post right anterior hip replacement with small greater trochanter fracture intraoperatively.No invasive treatment.It should be noted that this is only 14 days after implanting of the hip, and pain and limping are an expected event in that time range.
Additional Manufacturer Narrative
Product complaint # (b)(4).Investigation summary : no device associated with this report was received for examination.Examination of the provided x-ray images is unable to conclusively confirm this report.Only one of the provided images reflects the right hip arthroplasty.The image is cloudy in the area of the greater trochanter.If repaired the image is prior that surgery.The information received will be retained for potential series investigations if triggered by trend analysis 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 : a device history record (mre) review, was not possible because the required lot code is not known.

• Brand Name: CORAIL2 LAT COXA VARA SIZE 14
• Common Device Name: CORAIL AMT CEMENTLESS IMPLANT : HIP FEMORAL STEM
• Manufacturer (Section D): DEPUY ORTHOPAEDICS INC US; 700 orthopaedic drive; warsaw IN 46581 0988
• MDR Report Key: 12041507
• Report Number: 1818910-2021-13261
• Device Sequence Number: 17190323
• Product Code: LZO
• UDI-Device Identifier: 10603295168911
• UDI-Public: 10603295168911
• 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
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 06/23/2021

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?: No
• Operator of Device: Health Professional
• Device Model Number: 3L93714
• Device Catalogue Number: 3L93714
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 06/08/2021
• Supplement Date Received by Manufacturer: 07/16/2021
• Initial Report FDA Received Date: 06/22/2021
• Supplement Report FDA Received Date: 07/19/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: ALTRX NEUT 36IDX56OD; CORAIL2 LAT COXA VARA SIZE 14; DELTA CER HEAD 12/14 36MM +8.5; PINN CAN BONE SCREW 6.5MMX25MM; PINN CAN BONE SCREW 6.5MMX30MM; PINNACLE SECTOR II CUP 56MM; ALTRX NEUT 36IDX56OD; CORAIL2 LAT COXA VARA SIZE 14; DELTA CER HEAD 12/14 36MM +8.5; PINN CAN BONE SCREW 6.5MMX25MM; PINN CAN BONE SCREW 6.5MMX30MM; PINNACLE SECTOR II CUP 56MM
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 61 YR
• Patient Weight: 113