MAUDE Adverse Event Report: DEPUY IRELAND - 9616671 RECLAIM PRX BDY CONE 24X85; RECLAIM IMPLANT : HIP FEMORAL STEM

Model Number	1975-24-085
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Bone Fracture(s) (1870); No Code Available (3191)
Date of Event	10/13/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(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 femur fracture, intraoperative: periprosthetic fracture.Event is serious and is considered moderate.Event is possibly related to both device and procedure.Date of implantation: (b)(6) 2020.Date of event (onset): (b)(6) 2020.(right hip).Treatment: open reduction internal fixation with synthes cerclage cables x 3.
Additional Manufacturer Narrative
Product complaint # (b)(4).Investigation summary: no device associated with this report was received for examination.The provided x-ray images do not depict the reclaim stem platform that is the subject of this report.They do not aid in this investigation.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: RECLAIM PRX BDY CONE 24X85
• Common Device Name: RECLAIM IMPLANT : HIP FEMORAL STEM
• Manufacturer (Section D): DEPUY IRELAND - 9616671; loughbeg ringaskiddy co.; cork ; EI
• MDR Report Key: 10792091
• Report Number: 1818910-2020-24004
• Device Sequence Number: 3267253
• Product Code: KWA
• UDI-Device Identifier: 10603295076926
• UDI-Public: 10603295076926
• Combination Product (Y/N): N
• Initial Reporter State: CO
• Initial Reporter Country: US
• PMA/510(K) Number: K102080
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• 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): 10/21/2020

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: 1975-24-085
• Device Catalogue Number: 197524085
• Device Lot Number: J83K55
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 10/21/2020
• Supplement Date Received by Manufacturer: 12/03/2020
• Initial Report FDA Received Date: 11/05/2020
• Supplement Report FDA Received Date: 12/07/2020
• 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: 1.7MM CABLE WITH TI CRIMP; 1.7MM CABLE WITH TI CRIMP; 1.7MM CABLE WITH TI CRIMP; 5.0MM DIA TPRD HD PER SCRW 35; 5.0MM DIA TPRD HD PER SCRW 45; 5.0MM DIA TPRD HD PER SCRW 55; ALTRX +4 10D 40IDX64OD; DLT TS CER HD 12/14 40MM +8.5; PINN CAN BONE SCREW 6.5MMX15MM; PINN CAN BONE SCREW 6.5MMX15MM; PINN CAN BONE SCREW 6.5MMX20MM; PINN CAN BONE SCREW 6.5MMX20MM; PINN REVISION W/GRIPTION 70MM; RECLAIM ASSEMBLY TENSILE BAR; RECLAIM DISTAL TAPERED 22X190A; 1.7MM CABLE WITH TI CRIMP; 1.7MM CABLE WITH TI CRIMP; 1.7MM CABLE WITH TI CRIMP; 5.0MM DIA TPRD HD PER SCRW 35; 5.0MM DIA TPRD HD PER SCRW 45; 5.0MM DIA TPRD HD PER SCRW 55; ALTRX +4 10D 40IDX64OD; DLT TS CER HD 12/14 40MM +8.5; PINN CAN BONE SCREW 6.5MMX15MM; PINN CAN BONE SCREW 6.5MMX15MM; PINN CAN BONE SCREW 6.5MMX20MM; PINN CAN BONE SCREW 6.5MMX20MM; PINN REVISION W/GRIPTION 70MM; RECLAIM ASSEMBLY TENSILE BAR; RECLAIM DISTAL TAPERED 22X190A
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 58 YR
• Patient Weight: 124