MAUDE Adverse Event Report: DEPUY IRELAND - 9616671 RECLAIM DISTAL TAPERED 18X190A; RECLAIM IMPLANT : HIP FEMORAL STEM

Model Number	1977-18-190
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	07/31/2020
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
It was reported that the reamed to a 18mm diameter reamer.Inserted the 18mm x 190 stem and the stem sunk below the desired 85mm mark.Surgeon them extracted the stem and started to ream up to a 19,20,21mm.The surgeon noticed a pop when reaming the 21mm reamer.The surgeon then took an xray and noticed a femur fracture above the femur.Implanted a 21mm x 190 stem and then repaired the fracture with a synthes femoral locking plate.The surgeon did mention that we thought the 18mm x 190 stem potted on a existing fracture then sunk below the desired level.Doi: (b)(6) 2020, dor: (b)(6) 2020, right hip.
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.

• Brand Name: RECLAIM DISTAL TAPERED 18X190A
• Common Device Name: RECLAIM IMPLANT : HIP FEMORAL STEM
• Manufacturer (Section D): DEPUY IRELAND - 9616671; loughbeg ringaskiddy co.; cork ; EI
• MDR Report Key: 10402223
• Report Number: 1818910-2020-18055
• Device Sequence Number: 19583121
• Product Code: KWA
• UDI-Device Identifier: 10603295077213
• UDI-Public: 10603295077213
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K102080
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Device Explanted Year: 2020
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 07/31/2020

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: 1977-18-190
• Device Catalogue Number: 197718190
• Device Lot Number: J54Z59
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 07/31/2020
• Supplement Date Received by Manufacturer: 09/16/2020
• Initial Report FDA Received Date: 08/13/2020
• Supplement Report FDA Received Date: 09/17/2020
• 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: SYNTHES; UNK REAMER; SYNTHES; UNK REAMER
• Outcome Attributed to Adverse Event: Required Intervention