MAUDE Adverse Event Report: DEPUY IRELAND - 9616671 ACTIS COLLARED HIGH SIZE 10; HIP FEMORAL STEM

Catalog Number 101012100

Device Problem Patient-Device Incompatibility (2682)

Patient Problem Not Applicable (3189)

Event Date 11/20/2019

Event Type  malfunction  

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.If information is obtained that was not available for the initial medwatch, a follow-up medwatch, a follow-up medwatch will be filed as appropriate.

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 patient was having a left total hip.During the surgery, the surgeon broached to a 10 actis stem.The broach was very tight and rotationally stable.When the real implant was inserted, it sank all the way to the collar with no pressfit.The surgeon inserted the stem with his fingers and it seated fully and was loose.The surgeon went up one broach size and implanted the next size stem and got minimal pressfit, but the stem seemed to be stable and was retained.The pressfit of these stems is not enough to be solid.Doe: (b)(6) 2019.Left hip.

• Brand Name: ACTIS COLLARED HIGH SIZE 10
• Type of Device: HIP FEMORAL STEM
• Manufacturer (Section D): DEPUY IRELAND - 9616671; loughbeg ringaskiddy co.; cork ; EI
• Manufacturer (Section G): DEPUY ORTHOPAEDICS, INC. 1818910; 700 orthopaedic dr.; warsaw IN 46581 0988
• Manufacturer Contact: kara ditty-bovard ; 700 orthopaedic dr.; warsaw, IN 46581-0988 ; 6107428552
• MDR Report Key: 9459841
• MDR Text Key: 175561195
• Report Number: 1818910-2019-122819
• Device Sequence Number: 1
• Product Code: KWL
• UDI-Device Identifier: 10603295380627
• UDI-Public: 10603295380627
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K160907
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 11/20/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/12/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 101012100
• Device Lot Number: J4371R
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/15/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/05/2019
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Age: 54 YR