MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC; PROSTHESIS, ELBOW, HEMI-RADIAL, POLYMER

Device Problem Mechanical Problem (1384)

Patient Problems Pain (1994); Not Applicable (3189)

Event Type  Injury  

Manufacturer Narrative

This report is for an unknown radial stem/unknown lot.Part and lot numbers are unknown; udi number is unknown.Without a lot number the device history records review could not be completed.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.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 Description

It was reported patient was implanted with the radial head prosthesis implant and variable angle locking compression plate (va lcp) olecranon plate in 2015.During a follow up visit on unknown date in 2018, patient complained of vague elbow pain.X-rays revealed a lucency around the radial stem.Loosening of the radial head was noted.A preoperative decision was made to remove all hardware.Patient was returned to surgery on (b)(6) 2018 where surgeon removed the radial head, radial stem, a va lcp olecranon plate, three (3) 2.7mm va lcp locking screws, and two (2) 3.5mm cortex screws.Surgery was completed successfully with no delay.Concomitant medical products: variable angle (va) locking compression plate (lcp) olecranon plate (part 02.107.202, lot unknown, quantity 1), 2.7mm variable angle (va) locking compression plate (lcp) locking screws (part unknown, lot unknown, quantity 3), 3.5mm cortex screws (part unknown, lot unknown, quantity 2).This report is for one (1) unknown radial stem.This is report 2 of 2 for (b)(4).

Manufacturer Narrative

A product investigation was conducted.Based on the return product alone, the complaint cannot be confirmed.X-rays were not returned to us customer quality (cq).However, there are known issues with the radial head implants and appropriate actions have been taken to address the issue.There is also a recall that was initiated as part of field action investigation where ¿device loosening¿ was identified as a high harm and contributed to the recall of the product.Based on the capa, hhe and field action information us cq can confirm the complaint for loosening.Visual inspection: the unknown radial head was received at us cq with no signs of wear and attached to the radial stem.Visually the part looks pristine and there are no signs of implantation or explantation.No further investigation will be performed since there are known issues with the radial head and stem implants related to recall.Document/specification review: a dhr review could not be performed as the lot number is unknown.Conclusion: the complaint condition is confirmed.No definitive root cause was able to be determined as the circumstances surrounding the event are unknown.During the investigation no unidentified product design/manufacturing issues or discrepancies were observed (based on the image) that may have contributed to the complaint condition.Based on the investigation findings, it has been determined that no 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.

Manufacturer Narrative

The device was received, and the product evaluation is in progress.No conclusion can be drawn.Additionally, device history records review could not be completed without lot 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.

• Type of Device: 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: 7935926
• MDR Text Key: 122792874
• Report Number: 2939274-2018-54168
• Device Sequence Number: 1
• Product Code: KWI
• Combination Product (y/n): N
• PMA/PMN Number: K112030
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Remedial Action: Recall
• Type of Report: Initial,Followup,Followup
• Report Date: 09/11/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/04/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/27/2018
• Date Manufacturer Received: 10/31/2018
• Removal/Correction Number: Z-1124-2017
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 67 YR