MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US PINN CAN BONE SCREW 6.5MMX25MM; BONE SCREWS AND PINS : SCREWS

Model Number 1217-25-500

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Pulmonary Embolism (1498); No Code Available (3191)

Event Date 05/12/2020

Event Type  Injury  

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 Description

Clinical adverse event received for vascular - pulmonary embolism.Event is serious and is considered moderate.Event is definitely not related to device and is possibly related to procedure.Date of implantation: (b)(6) 2020.Date of event (onset): (b)(6) 2020.(right hip).

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.H10 additional narrative: corrected: h6 (patient).Removed code for device revision or replacement.H6 patient code: no code available (3191) was used to capture minor injury.

• Brand Name: PINN CAN BONE SCREW 6.5MMX25MM
• Type of Device: BONE SCREWS AND PINS : SCREWS
• Manufacturer (Section D): DEPUY ORTHOPAEDICS INC US; 700 orthopaedic drive; warsaw IN 46581 0988
• MDR Report Key: 10096503
• MDR Text Key: 193028156
• Report Number: 1818910-2020-12732
• Device Sequence Number: 1
• Product Code: LPH
• UDI-Device Identifier: 10603295009900
• UDI-Public: 10603295009900
• Combination Product (y/n): N
• PMA/PMN Number: K983014
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup
• Report Date: 05/14/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/28/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 1217-25-500
• Device Catalogue Number: 121725500
• Device Lot Number: D19111592
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 07/10/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: 12/14 ARTICUL 40MM M SPEC+8.5; ALTRX +4 NEUT 40IDX58OD; CEMENTRALIZER 12.0; DEPUY CMW 1 40G; PINN CAN BONE SCREW 6.5MMX20MM; PINN CAN BONE SCREW 6.5MMX25MM; PINN CAN BONE SCREW 6.5MMX25MM; PINN CAN BONE SCREW 6.5MMX40MM; PINN MULTIHOLE W/GRIPTION 58MM; SUMMIT CEMENTED STEM SZ5 HI
• Patient Outcome(s): Required Intervention
• Patient Age: 83 YR
• Patient Weight: 115