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

Catalog Number 101011050

Device Problem Malposition of Device (2616)

Patient Problem No Code Available (3191)

Event Date 06/03/2019

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.Investigation summary: no device associated with this report was received for examination.A worldwide complaint database search found no other related reported incidents against the provided product code/lot number combination since release for distribution.Based on previous investigations, this complication of joint replacement is unlikely to have been the result of a device failing to meet required specifications.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.

Event Description

It was reported that the patient dislocated her constrained liner.During the revision, the liner was removed and discovered to have a crack on the outer elevated edge of the poly.The locking ring was observed to be still in place on the exterior of the polyand the 36 ts femoral head was still attached to the femoral stem.Constrained liner was destroyed during the removal process by the surgeon.The surgeon chose to remove the femoral stem, which was well-fixed, for a modular revision stem in order to increase femoral anteversion.Revised to a tripolar.No history of falls or additional explanation for the dislocation.Doi: (b)(6) 2019.Dor: (b)(6) 2019, left hip.

• Brand Name: ACTIS COLLARED STD 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 dr.; warsaw IN 46581 0988
• Manufacturer Contact: kara ditty-bovard ; 700 orthopaedic dr.; warsaw, IN 46581-0988 ; 6107428552
• MDR Report Key: 8781514
• MDR Text Key: 150731511
• Report Number: 1818910-2019-98112
• Device Sequence Number: 1
• Product Code: KWL
• UDI-Device Identifier: 10603295380450
• UDI-Public: 10603295380450
• 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
• Report Date: 06/03/2019

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?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 101011050
• Device Lot Number: HZ7165
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 06/21/2019
• Initial Date FDA Received: 07/11/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/16/2018
• 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
• Treatment: PIN LNR CONS NEUT +4 36IDX58OD; UNKNOWN HIP FEMORAL HEAD
• Patient Outcome(s): Required Intervention
• Patient Age: 78 YR