MAUDE Adverse Event Report: DEPUY IRELAND - 9616671 ACTIS COLLARED HIGH SIZE 5; HIP FEMORAL STEM

Model Number 1010-12-050

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

Patient Problem Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Date 03/03/2020

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 notification received for revision of left total hip to address deep infection.Date of implantation: (b)(6) 2019; date of revision: (b)(6) 2020; (left hip).Treatment: explantation of cup, liner, hole eliminator, stem and head.

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 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 device history record (dhr) review, was not possible because the required lot code(s) was not provided.

• Brand Name: ACTIS COLLARED HIGH SIZE 5
• Type of Device: HIP FEMORAL STEM
• Manufacturer (Section D): DEPUY IRELAND - 9616671; loughbeg ringaskiddy co.; cork ; EI
• MDR Report Key: 10977008
• MDR Text Key: 220477073
• Report Number: 1818910-2020-26600
• Device Sequence Number: 1
• Product Code: KWL
• UDI-Device Identifier: 10603295380573
• UDI-Public: 10603295380573
• Combination Product (y/n): N
• PMA/PMN Number: K160907
• 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: 11/23/2020

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
• Device Operator: Health Professional
• Device Model Number: 1010-12-050
• Device Catalogue Number: 101012050
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 11/23/2020
• Initial Date FDA Received: 12/09/2020
• Supplement Dates Manufacturer Received: 01/11/2021
• Supplement Dates FDA Received: 01/12/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: ALTRX NEUT 32IDX50OD; APEX HOLE ELIM POSITIVE STOP; DELTA CER HEAD 12/14 32MM +1; PINNACLE 100 ACET CUP 50MM; ALTRX NEUT 32IDX50OD; APEX HOLE ELIM POSITIVE STOP; DELTA CER HEAD 12/14 32MM +1; PINNACLE 100 ACET CUP 50MM
• Patient Outcome(s): Required Intervention
• Patient Age: 55 YR
• Patient Weight: 66