MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC 10MM TI STRAIGHT RADIAL STEM 32MM-STERILE; PROSTHESIS, ELBOW, HEMI-RADIAL , POLYMER

Model Number	04.402.010S
Medical Device Problem Code	Unintended Movement (3026)
Health Effect - Clinical Codes	Failure of Implant (1924); No Code Available (3191)
Date of Event	01/01/2019
Type of Reportable Event	Serious Injury
Additional 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 or Problem 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) 10mm ti straight radial stem 32mm-sterile.This is report 2 of 2 for (b)(4).

• Brand Name: 10MM TI STRAIGHT RADIAL STEM 32MM-STERILE
• 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: 10373835
• Report Number: 2939274-2020-03416
• Device Sequence Number: 3120426
• Product Code: KWI
• UDI-Device Identifier: 10886982128072
• UDI-Public: (01)10886982128072
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K112030
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2016
• Device Explanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: company representative,other
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 07/16/2020

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 Model Number: 04.402.010S
• Device Catalogue Number: 04.402.010S
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 07/16/2020
• Initial Report FDA Received Date: 08/06/2020
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: UNKNOWN SCREWS
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 69 YR