MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US CEMENTRALIZER 9.25MM; HIP MISCELLANEOUS : CEMENT CENTRALIZER/PLUG

Catalog Number 137647000

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

Patient Problems Unspecified Infection (1930); No Code Available (3191)

Event Date 04/22/2019

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.

Event Description

The patient was revised to address infection and loosening at the cement to implant interface.There was also removal of implants, wash out and re-implantation.Doi: (b)(6) 2019; dor: (b)(6) 2019, left hip.

Manufacturer Narrative

Product complaint # (b)(4).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.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

• Brand Name: CEMENTRALIZER 9.25MM
• Type of Device: HIP MISCELLANEOUS : CEMENT CENTRALIZER/PLUG
• Manufacturer (Section D): DEPUY ORTHOPAEDICS INC US; 700 orthopaedic drive; warsaw IN 46582 0988
• Manufacturer (Section G): DEPUY ORTHOPAEDICS, INC. 1818910; 700 orthopaedic dr.; warsaw IN 46582 0988
• Manufacturer Contact: kara ditty-bovard ; 1210 ward avenue; west chester, PA 19380-0988 ; 6107428552
• MDR Report Key: 8604796
• MDR Text Key: 144858989
• Report Number: 1818910-2019-93300
• Device Sequence Number: 1
• Product Code: JDK
• UDI-Device Identifier: 10603295034551
• UDI-Public: 10603295034551
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K871510
• 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: 04/22/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/13/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 137647000
• Device Lot Number: J27P92
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/31/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/28/2019
• 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 Outcome(s): Required Intervention
• Patient Age: 46 YR