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

Catalog Number 101012050

Device Problem Fitting Problem (2183)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 10/03/2018

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 broached to a 5 hi offset actis, it fit perfectly.He calcar planed even with the broach, did a trial reduction with x-rays.The real actis implant upon impaction would not seat, it was 2 mm proud(collar).

Manufacturer Narrative

Product complaint (b)(4).Investigation summary no device was received.Depuy synthes considers the investigation closed at this time.Should additional information be received, the information will be reviewed and the investigation may be re-opened as necessary.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

• Brand Name: ACTIS COLLARED HIGH SIZE 5
• 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 drive; warsaw IN 46582 0988
• Manufacturer Contact: kara ditty-bovard ; 1210 ward avenue; west chester, PA 19380-XXXX ; 6103142063
• MDR Report Key: 7957871
• MDR Text Key: 123439622
• Report Number: 1818910-2018-72246
• Device Sequence Number: 1
• Product Code: KWL
• UDI-Device Identifier: 10603295380573
• UDI-Public: 10603295380573
• 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
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 10/03/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 101012050
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 10/03/2018
• Initial Date FDA Received: 10/11/2018
• Supplement Dates Manufacturer Received: 11/21/2018
• Supplement Dates FDA Received: 11/29/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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: 58 YR
• Patient Weight: 74