MAUDE Adverse Event Report: FINSBURY ORTHOPAEDICS LIMITED MITCH TRH RESURFACING HEAD 46MM; HIP METAL FEMORAL HEADS

Catalog Number MFR99885246

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

Patient Problems Hypersensitivity/Allergic reaction (1907); Test Result (2695); No Code Available (3191)

Event Date 04/20/2017

Event Type  Injury  

Manufacturer Narrative

Product complaint : (b)(4).Investigation summary: no device associated with this report was received for examination.A worldwide lot specific complaint database search, or device history record (dhr) review, was not possible because the required lot code(s) was not provided.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.(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 underwent a left hip surgery, months later, following screenings, the patient tested positive for allergy to cobalt and chloride ions, in addition to the high level of nickel and cobalt ions in the blood.The patient underwent a revision surgery in another hospital after drainage of a lot of serum-hematic fluid.

• Brand Name: MITCH TRH RESURFACING HEAD 46MM
• Type of Device: HIP METAL FEMORAL HEADS
• Manufacturer (Section D): FINSBURY ORTHOPAEDICS LIMITED; 13 mole business park, randall; leatherhead, surrey
• 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 ; 6103142063
• MDR Report Key: 8182148
• MDR Text Key: 130972383
• Report Number: 1818910-2018-78790
• Device Sequence Number: 1
• Product Code: JDG
• Combination Product (y/n): N
• Reporter Country Code: IT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,other
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 11/26/2018

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?: No
• Device Operator: Health Professional
• Device Catalogue Number: MFR99885246
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 11/26/2018
• Initial Date FDA Received: 12/19/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention