MAUDE Adverse Event Report: DEPUY IRELAND - 9616671 ACTIS COLLARED HIGH SIZE 4; HIP FEMORAL STEM

Model Number 1010-12-040

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

Patient Problems Stroke/CVA (1770); No Code Available (3191)

Event Date 08/12/2020

Event Type  Injury  

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 Description

Clinical adverse event received for cerebrovascular accident.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).Treatment: diagnostic intervention (unspecified); observation.

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: ACTIS COLLARED HIGH SIZE 4
• Type of Device: HIP FEMORAL STEM
• Manufacturer (Section D): DEPUY IRELAND - 9616671; loughbeg ringaskiddy co.; cork ; EI
• MDR Report Key: 10685468
• MDR Text Key: 211534554
• Report Number: 1818910-2020-22468
• Device Sequence Number: 1
• Product Code: KWL
• UDI-Device Identifier: 10603295380566
• UDI-Public: 10603295380566
• Combination Product (y/n): N
• PMA/PMN Number: K160907
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,study
• Type of Report: Initial,Followup
• Report Date: 09/30/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/15/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 1010-12-040
• Device Catalogue Number: 101012040
• Device Lot Number: J67P49
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 11/12/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: ALTRX NEUT 32IDX50OD; ARTICUL/EZE BALL 32 +1 GR; PINN CAN BONE SCREW 6.5MMX25MM; PINNACLE SECTOR II CUP 50MM; ALTRX NEUT 32IDX50OD; ARTICUL/EZE BALL 32 +1 GR; PINN CAN BONE SCREW 6.5 MMX25 MM; PINNACLE SECTOR II CUP 50 MM
• Patient Outcome(s): Required Intervention
• Patient Age: 72 YR
• Patient Weight: 71