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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC UNK - RADIAL HEAD PROSTHESIS; PROSTHESIS, ELBOW, HEMI-RADIAL, POLYMER
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WRIGHTS LANE SYNTHES USA PRODUCTS LLC UNK - RADIAL HEAD PROSTHESIS; PROSTHESIS, ELBOW, HEMI-RADIAL, POLYMER Back to Search Results
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Cyst(s) (1800); Pain (1994); Loss of Range of Motion (2032); No Code Available (3191)
Event Type  Injury  
Manufacturer Narrative
This report is for an unknown radial head prosthesis/unknown lot number.Without the specific part number, the udi number and 510k number is unknown.Complainant part is expected to be returned for manufacturer review/investigation, but has yet to be received.(b)(4).Without a lot number, the device history records review could not be completed as no product was received.The investigation could not be completed; 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
It was reported that on june 5, 2019, the surgeon will be removing a radial head replacement that was implanted by a different surgeon.The surgery is scheduled for (b)(6) 2019, the patient has had pain since 2012, sharp and stabbing in nature.Worse with lifting or twisting.X-rays review revealed as mentioned by the surgeon note a cyst in capitellum, there was no mention of the device appearing loose or any malfunction.The patient has received physical therapy (pt) and anti-inflammatory medications without improvement in pain.The radial head replacement was done in 2012 for non-union of a previous radial head fracture.This product is recalled.Patient status is unknown.This complaint involves two (2) devices.This report is for one (1) unk - radial head prosthesis.This report is 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.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) 2019, the surgeon will be removing a radial head replacement that was implanted by a different surgeon.The patient has had pain since 2012, sharp and stabbing in nature.Worse with lifting or twisting.X-rays review revealed as mentioned by the surgeon note a cyst in capitellum, there was no mention of the device appearing loose or any malfunction.The patient has received physical therapy (pt) and anti-inflammatory medications without improvement in pain.The radial head replacement was done in 2012 for non-union of a previous radial head fracture.This product is recalled.Patient status is unknown.
 
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.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
UNK - RADIAL HEAD PROSTHESIS
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 Key8755839
MDR Text Key149919625
Report Number2939274-2019-58991
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
Type of Report Initial,Followup,Followup
Report Date 06/05/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received07/02/2019
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Health Professional
Was Device Available for Evaluation? No
Date Manufacturer Received08/02/2019
Patient Sequence Number1
Patient Outcome(s) Required Intervention;
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