MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC 22MM COCR RADIAL HEAD 2MM HT EXTENSION/14.5MM-STER; PROSTHESIS, ELBOW, HEMI-RADIAL , POLYMER

Model Number 09.402.222S

Device Problem Unintended Movement (3026)

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

Event Type  Injury  

Manufacturer Narrative

(b)(4).Device history lot: (b)(4).Release to warehouse date: 08-aug-2014, expiration date: 31-jul-2019, part number: 09.402.222s, 22mm cocr radial head 2mm height extension/14.5mm ¿ sterile, lot number: 7608124 (sterile).This lot met all dimensional, visual, sterility and packaging criteria at the time of release with no issues documented during the inspection or release of the product that would contribute to this complaint condition.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) 2018, the patient underwent a revision with wright medial radial head implant.Removal was due to a loose implant.Bone loss around the stem was also reported.The procedure was completed successfully.Patient outcome is stable.This report is for one (1) 22mm cocr radial head 2mm ht extension/14.5mm-ster.This is report 1 of 2 for (b)(4).

• Brand Name: 22MM COCR RADIAL HEAD 2MM HT EXTENSION/14.5MM-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: 8237200
• MDR Text Key: 132790033
• Report Number: 2939274-2019-55777
• Device Sequence Number: 1
• Product Code: KWI
• UDI-Device Identifier: 10886982132659
• UDI-Public: (01)10886982132659
• 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,health
• Reporter Occupation: Other Health Care Professional
• Remedial Action: Recall
• Type of Report: Initial
• Report Date: 12/14/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/10/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 07/31/2019
• Device Model Number: 09.402.222S
• Device Catalogue Number: 09.402.222S
• Device Lot Number: 7608124
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/14/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/08/2014
• Is the Device Single Use?: Yes
• Type of Device Usage: Unknown
• Removal/Correction Number: Z-1124-2017
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention