MAUDE Adverse Event Report: DEPUY IRELAND - 9616671 ACTIS COLLARED STD SIZE 8; HIP FEMORAL STEM

Model Number 1010-11-080

Device Problem Defective Device (2588)

Patient Problem Insufficient Information (4580)

Event Date 06/23/2021

Event Type  malfunction  

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

It was reported that the surgeon states that the 2 implants were out of spec.Doi: (b)(6) 2021: dor: (b)(6) 2021: hip unknown.

Manufacturer Narrative

Product complaint # (b)(4).Investigation summary: the returned device was examined by a depuy senior quality engineer.There is no evidence to indicate any out of specification conditions on the returned stem.A review of the device manufacturing records found no related deviations or anomalies.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 review of the device manufacturing records found no related deviations or anomalies.Device history review: a review of the device manufacturing records found no related deviations or anomalies.H6 investigation conclusions: appropriate term/code not available (d17) used to capture cause cannot be traced to device (d10).

• Brand Name: ACTIS COLLARED STD SIZE 8
• Type of Device: HIP FEMORAL STEM
• Manufacturer (Section D): DEPUY IRELAND - 9616671; loughbeg ringaskiddy co.; cork ; EI
• MDR Report Key: 12180692
• MDR Text Key: 261932480
• Report Number: 1818910-2021-15377
• Device Sequence Number: 1
• Product Code: MEH
• UDI-Device Identifier: 10603295380481
• UDI-Public: 10603295380481
• Combination Product (y/n): N
• PMA/PMN Number: K150862
• 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: 06/23/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/16/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 1010-11-080
• Device Catalogue Number: 101011080
• Device Lot Number: J99A67
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/13/2021
• Date Manufacturer Received: 08/18/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: DELTA CER HEAD 12/14 36MM +5