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
Medical Device Problem Code	Unintended Movement (3026)
Health Effect - Clinical Codes	Failure of Implant (1924); No Code Available (3191)
Type of Reportable Event	Serious Injury
Additional 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 or Problem 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
• Common Device Name: PROSTHESIS, ELBOW, HEMI-RADIAL , POLYMER
• Manufacturer (Section D): WRIGHTS LANE SYNTHES USA PRODUCTS LLC; 1302 wrights lane east; west chester PA 19380
• MDR Report Key: 8237200
• Report Number: 2939274-2019-55777
• Device Sequence Number: 16208836
• Product Code: KWI
• UDI-Device Identifier: 10886982132659
• UDI-Public: (01)10886982132659
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K112030
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Explanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Other Health Care Professional
• Remedial Action: Recall
• Type of Report: Initial
• Report Date (Section B): 12/14/2018

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?: Yes
• Operator of Device: 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
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 12/14/2018
• Initial Report FDA Received Date: 01/10/2019
• If action reported to FDA under 21 USC 360i(g), list FDA-assigned Recall Number or include a statement: Z-1124-2017
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention