MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC 22MM COCR RADIAL HEAD 6MM HT EXTENSION/18.5MM-STER; PROSTHESIS, ELBOW, HEMI-RADIAL , POLYMER

Model Number	09.402.622S
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Pain (1994)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Complainant part is not expected to be returned for manufacturer review/investigation.Device history records review was attempted: device history lot - part #: 09.402.422s, lot#: 6905326 (sterile) - 22mm cocr radial head 4mm ht extension/16.5 mm - sterile.Part number provided 09.402.622s is invalid for lot 6905326.It should be 09.402.422s.Dhr has been requested.The investigation could not be completed; no conclusion could be drawn, as no product was received.Investigation summary: product was not returned.Based on the information available, it has been determined that no corrective and/or preventative action is proposed.This complaint will be accounted for and monitored via post market surveillance activities.If additional information is made available, the investigation will be updated as applicable.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 a patient underwent removal of a radial head and stem prosthesis on (b)(6) 2018.The removal was completed successfully with no patient harm.The patient was not revised to anything following the procedure.It is unknown why the devices were removed.It was reported that it may have been due to a patient's complaint of pain.This report involves 2 devices.This report is 1 of 2 for (b)(4).
Additional Manufacturer Narrative
Corrected data: manufacture date is unknown.Dhr could not be completed as lot number does not match part number.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.

• Brand Name: 22MM COCR RADIAL HEAD 6MM HT EXTENSION/18.5MM-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: 7379544
• Report Number: 2939274-2018-51286
• Device Sequence Number: 16418286
• Product Code: KWI
• UDI-Device Identifier: 10886982132772
• UDI-Public: (01)10886982132772(17)UNK(10)6905326
• Combination Product (Y/N): N
• Initial Reporter State: TX
• 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: Health Professional
• Remedial Action: Recall
• Type of Report: Initial,Followup
• Report Date (Section B): 04/02/2018

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
• Operator of Device: Health Professional
• Device Model Number: 09.402.622S
• Device Catalogue Number: 09.402.622S
• Device Lot Number: 6905326
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 02/28/2018
• Supplement Date Received by Manufacturer: 04/02/2018
• Initial Report FDA Received Date: 03/28/2018
• Supplement Report FDA Received Date: 04/24/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 70 YR
• Patient Weight: 63