MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC 7MM TI CURVED RADIAL STEM 42MM-STERILE; PROSTHESIS, ELBOW, HEMI-RADIAL , POLYMER

Model Number	04.402.027S
Medical Device Problem Code	Unintended Movement (3026)
Health Effect - Clinical Codes	Failure of Implant (1924); Osteolysis (2377); No Code Available (3191)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).Device history lot: part # 04.402.027s, synthes lot # 7608079, expiration date: 30 sep 2019, release to warehouse date: 10 nov 2014, (b)(4).No ncr's were generated during production.Review of the device history record(s) showed that there were no issues during the manufacture of this product, and any sub-components, which 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) 7mm ti curved radial stem 42mm-sterile.This is report 2 of 2 for (b)(4).

• Brand Name: 7MM TI CURVED RADIAL STEM 42MM-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: 8237199
• Report Number: 2939274-2019-55778
• Device Sequence Number: 263246
• Product Code: KWI
• UDI-Device Identifier: 10886982128096
• UDI-Public: (01)10886982128096
• 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: 09/30/2019
• Device Model Number: 04.402.027S
• Device Catalogue Number: 04.402.027S
• Device Lot Number: 7608079
• 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