MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US SLF TAPPING ROOF PILE SCRW25MM; BONE SCREWS AND PINS : SCREWS

Model Number	1011-40-025
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	02/18/2021
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
It was reported that the patient broke the protrusio cage and a few screws implanted back in 2019.Surgeon removed all cage and screws along with a cemented cup and replaced with a pinnacle revision cup and used dual mobility to help patient with stability.No surgical delay.Doi:(b)(6) 2019, dor: (b)(6) 2021, left 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.Device history lot: a search of the depuy nonconformance (nc) quality system found no nc¿s associated with this product/lot combination.Device history review: a search of the depuy nonconformance (nc) quality system found no nc¿s associated with this product/lot combination.

• Brand Name: SLF TAPPING ROOF PILE SCRW25MM
• Common Device Name: BONE SCREWS AND PINS : SCREWS
• Manufacturer (Section D): DEPUY ORTHOPAEDICS INC US; 700 orthopaedic drive; warsaw IN 46581 0988
• MDR Report Key: 11436238
• Report Number: 1818910-2021-04586
• Device Sequence Number: 17162812
• Product Code: JDJ
• UDI-Device Identifier: 10603295000433
• UDI-Public: 10603295000433
• Combination Product (Y/N): N
• Initial Reporter State: IN
• Initial Reporter Country: US
• PMA/510(K) Number: K962007
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Device Explanted Year: 2021
• 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): 02/18/2021

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: 1011-40-025
• Device Catalogue Number: 101140025
• Device Lot Number: J30C31
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 02/18/2021
• Supplement Date Received by Manufacturer: 04/01/2021
• Initial Report FDA Received Date: 03/08/2021
• Supplement Report FDA Received Date: 04/02/2021
• 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: ARTICUL/EZE BALL 32 +5 BR; PINN CAN BONE SCREW 6.5MMX15MM; PINN CAN BONE SCREW 6.5MMX30MM; PROSTALAC ACET CUP 42X32; PROTRUSIO CAGE 52OD X 49ID L; SLF TAPPING ROOF PILE SCRW15MM; SLF TAPPING ROOF PILE SCRW20MM; SLF TAPPING ROOF PILE SCRW35MM; UNKNOWN BONE CEMENT; ARTICUL/EZE BALL 32 +5 BR; PINN CAN BONE SCREW 6.5MMX15MM; PINN CAN BONE SCREW 6.5MMX30MM; PROSTALAC ACET CUP 42X32; PROTRUSIO CAGE 52OD X 49ID L; SLF TAPPING ROOF PILE SCRW15MM; SLF TAPPING ROOF PILE SCRW20MM; SLF TAPPING ROOF PILE SCRW35MM; UNKNOWN BONE CEMENT
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 51 YR