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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC 7MM TI CURVED RADIAL STEM 42MM-STERILE; PROSTHESIS, ELBOW, HEMI-RADIAL , POLYMER
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WRIGHTS LANE SYNTHES USA PRODUCTS LLC 7MM TI CURVED RADIAL STEM 42MM-STERILE; PROSTHESIS, ELBOW, HEMI-RADIAL , POLYMER Back to Search Results
Catalog Number 04.402.027S
Device Problem Unintended Movement (3026)
Patient Problems Failure of Implant (1924); Pain (1994); Loss of Range of Motion (2032)
Event Type  Injury  
Manufacturer Narrative
Brand name, common device name, procode, mfr, lot #, part #, udi #, 510k: this report is for an unknown radial head prosthesis: radial stem/unknown lot.Part and lot numbers are unknown; udi number is unknown.Device evaluated by mfr, manufacture date: 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 that on (b)(6) 2018, the patient underwent a revision surgery to remove and repair the patient's arm as a result of the faulty synthes radial head prosthesis system.On (b)(6) 2016, the patient suffered an elbow fracture that required surgery and the placement of a synthes radial head prosthesis system in her arm.On (b)(6) 2017, the patient discovered that the synthes radial head prosthesis system that had been surgically installed in her arm had failed.The patient sustained injuries because of the defective and dangerous condition of the synthes radial head prosthesis the patient received.The device was prone to having the radial stem loosen post operatively at the stem bone interface.The aforementioned defects existed when the synthes radial head prosthesis system left the synthes usa products llc hands.This report is for one (1) radial head prosthesis: radial stem.This is report 2 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.
 
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.Manufacturing location: supplier - (b)(4)nemcomed / inspected, packaged and released by: monument, release to warehouse date: 23-mar-2015, expiration date: 01-feb-2020, part number: 04.402.027s, 7mm ti curved radial stem 42mm ¿ sterile, lot number: 7838230 (sterile), component part(s) reviewed: part number: 21069, tialnbri18.00, lot number: 6436951.This lot met all dimensional, visual, sterility and packaging criteria with no issues documented during the inspection or release of the product that 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.
 
Event Description
(b)(4)- this pc was due to a broken radial head prosthesis.(b)(4) - this pc was due to an allegation against the synthes olecranon locking plate.
 
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.Additional reporter contact information provided for reporting.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 a revision surgery to remove and repair the patient's arm as a result of the faulty synthes radial head prosthsis system.The patient underwent left elbow nodule excision including bone, left radial head athroplasty removal, left radial head arthroplasty revision.On (b)(6) 2016, the patient suffered an elbow fracture that required surgery and the placement of a synthes radial head prosthesis sytem in her arm.On (b)(6) 2017, the patient discovered that the synthes radial head prosthesis system that had been surgically installed in her arm had failed.The patient sustained injuries because of the defective and dangerous condition of the synthes radial head prosthesis the patient received.The device was prone to having the radial stem loosen post operatively at the stem bone interface.The aforementioned defects existed when the synthes radial head prsothesis system left the synthes usa products llc hands.On (b)(6) 2018, the patient had a removal removal of the hardware from the right olecranon and right elbow capsular release with bone resecton.
 
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.
 
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
7MM TI CURVED RADIAL STEM 42MM-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 Key8632488
MDR Text Key145789231
Report Number2939274-2019-58205
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 health professional,other
Remedial Action Recall
Type of Report Initial,Followup,Followup,Followup,Followup
Report Date 04/23/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received05/22/2019
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date02/01/2020
Device Catalogue Number04.402.027S
Device Lot Number7838230
Was Device Available for Evaluation? No
Date Manufacturer Received09/30/2019
Removal/Correction NumberZ-1124-2017
Patient Sequence Number1
Patient Outcome(s) Required Intervention;
Patient Age47 YR
Patient Weight72
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