MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC 24MM COCR RADIAL HEAD 6MM HT EXTENSION/19.0MM-STER; PROSTHESIS, ELBOW, HEMI-RADIAL , POLYMER

Model Number 09.402.624S

Device Problem Unintended Movement (3026)

Patient Problems Failure of Implant (1924); No Code Available (3191)

Event Date 01/01/2019

Event Type  Injury  

Manufacturer Narrative

Initial reporter is jnj representative.Without a lot number, the device history records review could not be completed as no product was received.The investigation could not be completed, no product was received; no conclusion could be drawn at the time of filing this report.(b)(4).Device was used for treatment, not diagnosis.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 on (b)(6) 2019, the patient underwent an elbow radial head replacement surgery due to the loosening of the radial head prosthesis as confirmed through x-ray on an unknown date.On or about (b)(6) 2016, the patient was implanted with a depuy synthes radial head implant system.Postoperatively, patient experienced increasing pain, loss of range of motion, weakness of right elbow and surrounding regions and decreased function of the elbow.It was unknown if the surgery was completed successfully with or without delay.The patient outcome was unknown.Concomitant device reported: unknown screws (part # unknown, lot # unknown, quantity unknown).This complaint involves two (2) devices only.This report is for (1) 24mm cocr radial head 6mm ht extension/19.0mm-ster.This is report 1 of 2 for (b)(4).

• Brand Name: 24MM COCR RADIAL HEAD 6MM HT EXTENSION/19.0MM-STER
• Type of Device: PROSTHESIS, ELBOW, HEMI-RADIAL , POLYMER
• Manufacturer (Section D): WRIGHTS LANE SYNTHES USA PRODUCTS LLC; 1302 wrights lane east; west chester PA 19380
• Manufacturer (Section G): MONUMENT; 1101 synthes avenue; monument CO 80132
• Manufacturer Contact: kara ditty-bovard ; 1302 wrights lane east; west chester, PA 19380 ; 6103142063
• MDR Report Key: 10373818
• MDR Text Key: 201888324
• Report Number: 2939274-2020-03415
• Device Sequence Number: 1
• Product Code: KWI
• UDI-Device Identifier: 10886982132789
• UDI-Public: (01)10886982132789
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K112030
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,other
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 07/16/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/06/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 09.402.624S
• Device Catalogue Number: 09.402.624S
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/16/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Treatment: UNKNOWN SCREWS
• Patient Outcome(s): Required Intervention
• Patient Age: 69 YR