MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC 6MM TI STRAIGHT RADIAL STEM 24MM-STERILE; PROSTHESIS, ELBOW, HEMI-RADIAL, POLYMER

Model Number	04.402.006S
Medical Device Problem Code	Migration or Expulsion of Device (1395)
Health Effect - Clinical Code	Pain (1994)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Device has not been explanted.Complainant part is not expected to be returned for manufacturer review/investigation.The investigation could not be completed; no conclusion could be drawn, as no product was received.A device history records review has been requested.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 a patient was originally implanted with a 6mm titanium straight radial stem with a radial head on (b)(6) 2016.The patient was reported to be progressing fine until recently when the patient visited the clinic with reports of pain in the forearm.X-rays taken show that the stem of the radial head was loose.No revision procedure has been planned at this time.Concomitant devices: 18mm cocr radial head 2mm ht extension/13.5mm-ster (part: 09.402.218s, lot: 7607087, quantity: 1) this report is for a 6mm ti straight radial stem 24mm-sterile.This is report 1 of 1 for (b)(4).
Additional Manufacturer Narrative
Device history records review was completed for part# 04.402.006s, lot# 9983203.Manufacturing location: (b)(4), release to warehouse date: jul 12, 2016, expiry date: may 31, 2021.No non conformance reports were generated during production.Review of the device history records showed that there were no issues during the manufacture of the product that would contribute to this complaint condition.Visual inspection performed at customer quality on the images provided confirmed that the stem of the device backed out with migration of head and stem unit towards humerus.This complaint condition was confirmed.Both functional test and complaint replication is not possible to be performed at customer quality as the device was not returned.Relevant product drawings were reviewed and no design issues were identified.While no root cause could be determined it is likely that any unintended excessive forces encountered by the device during patient's post-op activities could have contributed to this complaint condition.Relevant actions have been taken to address the issue.Based on the information available, it has been determined that no additional corrective and/or preventative action is proposed 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: 6MM TI STRAIGHT RADIAL STEM 24MM-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: 7588054
• Report Number: 2939274-2018-52450
• Device Sequence Number: 11151873
• Product Code: KWI
• UDI-Device Identifier: 10886982128034
• UDI-Public: (01)10886982128034
• Combination Product (Y/N): N
• Initial Reporter State: NC
• Initial Reporter Country: US
• PMA/510(K) Number: K112030
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2016
• 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): 05/17/2018

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: 05/31/2021
• Device Model Number: 04.402.006S
• Device Catalogue Number: 04.402.006S
• Device Lot Number: 9983203
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 05/17/2018
• Supplement Date Received by Manufacturer: 07/13/2018
• Initial Report FDA Received Date: 06/11/2018
• Supplement Report FDA Received Date: 07/13/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• 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