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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: WRIGHTS LANE : SYNTHES USA PRODUCTS LLC 8MM TI STRAIGHT RADIAL STEM 28MM-STERILE; PROSTHESIS, ELBOW, HEMI-RADIAL, POLYMER
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WRIGHTS LANE : SYNTHES USA PRODUCTS LLC 8MM TI STRAIGHT RADIAL STEM 28MM-STERILE; PROSTHESIS, ELBOW, HEMI-RADIAL, POLYMER Back to Search Results
Catalog Number 04.402.008S
Device Problem Unintended Movement (3026)
Patient Problems Pain (1994); Loss of Range of Motion (2032)
Event Type  Injury  
Manufacturer Narrative
Additional narrative: patient age/date of birth and weight are unknown.510k: this report is for an unknown radial stem/unknown lot.Part and lot number are unknown; udi number is unknown.Device has not been reported as explanted.Complainant part is not expected to be returned for manufacturer review/investigation.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.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 a patient with a radial head prosthesis has a loose radial stem, is experiencing pain, has limited pronation, post-nation and does not have full flexion since the radial stem previously implanted is loose and has some movement.The patient was implanted with the radial head prosthesis on (b)(6) 2017 and has been experiencing some amount of pain ever since.The patient underwent an unknown analysis to check his movement limitations on an unknown date.The analysis stated that the patient is around 10-15% limited in terms of permanent disability.During a follow-up visit with their surgeon, unknown number of x-rays taken showed some loosening and some movement with the stem.A removal / revision of radial head prosthesis has not been scheduled.Concomitant devices reported: unknown radial head (part/lot unknown, quantity 1).This report is for an unknown radial stem.(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.H10 additional narrative: 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 (b)(6) 2018, the patient underwent removal of (1) radial head prosthesis implant because the radial head prosthesis has a loose radial stem.The implant has eroded through the radial neck.There is a chunk of bone presumed to come off the radial neck that is in the antecubital space, volar of the elbow.Also, there is increased shadowing over the capitellum.The patient is also expering right arm pain.Concomitant devices reported: 24mm cocr radial head 2mm ht extension/15.0mm-ster (part # 09.402.224s, lot # 7607091, quantity 1).This report is for one (1) 8mm ti straight radial stem 28mm-sterile.
 
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.Patient height: 167.64cm.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.H10 additional narrative: b6: medical history updated; b7: tests/lab data updated; d4: updated; h6: patient code updated; h3, h6: investigation summary.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 history lot.Part number:04.402.008s.Synthes lot number: 7640883.Supplier lot number: n/a.Release to warehouse date: (b)(6) 2014.Expiration date: (b)(6) 2019.Manufactured by synthes monument.No ncrs were generated during production.Device history review: review of the device history record showed that there were no issues during the manufacture of this product, and any subcomponents, 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.
 
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Brand Name
8MM TI STRAIGHT RADIAL STEM 28MM-STERILE
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 Key7170011
MDR Text Key96585630
Report Number2939274-2018-50104
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 12/08/2017
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received01/05/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date09/03/2019
Device Catalogue Number04.402.008S
Device Lot Number7640883
Was Device Available for Evaluation? No
Date Manufacturer Received07/01/2020
Is This a Reprocessed and Reused Single-Use Device? No
Removal/Correction NumberZ-1124-2017
Patient Sequence Number1
Treatment
24MM COCR RADIAL HEAD 2MM HT EXTENSION/15.0MM-STER.
Patient Outcome(s) Required Intervention;
Patient Weight64
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