Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC; PROSTHESIS, ELBOW, HEMI-RADIAL, POLYMER
  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

WRIGHTS LANE SYNTHES USA PRODUCTS LLC; PROSTHESIS, ELBOW, HEMI-RADIAL, POLYMER Back to Search Results
Device Problem Unintended Movement (3026)
Patient Problems Failure of Implant (1924); Pain (1994)
Event Type  Injury  
Manufacturer Narrative
This report is for an unknown radial head/unknown lot.Part and lot numbers are unknown; udi number is unknown.Device implanted on an unknown date in 2015.Complainant part is expected to be returned for manufacturer review/investigation, but has yet to be received.Without a lot number the device history records review could not be completed.The investigation could not be completed; no conclusion could be drawn, as no product was received.A review of the device history records 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 Description
It was reported that, on an unknown date in 2015, the radial head prosthesis and variable angle (va) locking compression plate (lcp) olecranon plate were implanted in the patient.During a follow-up appointment in 2018, the patient complained of a vague elbow pain where x-rays showed a lucency around the stem of the radial head implant.On (b)(6) 2018, the radial head prosthesis and va-lcp olecranon plate were explanted due to loosening of the radial head.It was preoperatively decided that all hardware would be removed.The procedure and patient outcome are unknown.Concomitant devices reported: variable angle (va) locking compression plate (lcp) olecranon plate (part# 02.107.202, lot# unknown, quantity 1), unknown 2.7mm variable angle (va) locking compression plate (lcp) locking screws (part# unknown, lot# unknown, quantity 3), unknown titanium radial stem (part# unknown, lot# unknown, quantity 1), unknown 3.5mm cortex screws (part# unknown, lot# unknown, quantity 2), this is report 1 of 1 for (b)(4).
 
Event Description
It was further reported that there was no surgical delay and the procedure was completed successfully.Concomitant devices: 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).
 
Manufacturer Narrative
Depuy synthes is submitting this report pursuant to the provisions of 21 cfr, part 803.This report may be based on information which depuy synthes has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, depuy synthes or its employees that the report constitutes an admission that the device, depuy synthes, or its employees caused or contributed to the potential event described in this report.Updated concomitant devices.Therapy date is unknown date in 2015.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
Depuy synthes is submitting this report pursuant to the provisions of 21 cfr, part 803.This report may be based on information which depuy synthes has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, depuy synthes or its employees that the report constitutes an admission that the device, depuy synthes, or its employees caused or contributed to the potential event described in this report.The device was received, the investigation is in progress, no conclusion could be drawn at the time of filing this report.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
This is report 1 of 2 for (b)(4).
 
Manufacturer Narrative
Depuy synthes is submitting this report pursuant to the provisions of 21 cfr, part 803.This report may be based on information which depuy synthes has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, depuy synthes or its employees that the report constitutes an admission that the device, depuy synthes, or its employees caused or contributed to the potential event described in this report.If the information is unknown, not available or does not apply, the section/field of the form is left blank.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.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

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 Key7893457
MDR Text Key120853029
Report Number2939274-2018-53886
Device Sequence Number1
Product Code KWI
Combination Product (y/n)N
PMA/PMN Number
K112030
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Remedial Action Recall
Type of Report Initial,Followup,Followup,Followup
Report Date 09/11/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received09/20/2018
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 Manufacturer09/27/2018
Date Manufacturer Received10/31/2018
Removal/Correction NumberZ-1124-2017
Patient Sequence Number1
Patient Outcome(s) Required Intervention;
Patient Age67 YR
-
-