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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
Model Number 04.402.008S
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problem Pain (1994)
Event Date 04/24/2020
Event Type  Injury  
Event Description
It was reported that on (b)(6) 2020, the patient reported radiating pain in right elbow.On (b)(6) 20216 the patient underwent for a surgery to have depuy synthes radial head prosthesis system implanted in the right elbow.On (b)(6) 2020, the patient underwent surgery to remove the implant.It was unknown if the removal surgery completed successfully.The patient outcome was unknown.This complaint involves (2) devices.This report is for (1) unk - radial head prosthesis: radial stem.This is report 1 of 1 for complaint (b)(4).
 
Manufacturer Narrative
Product complaint # (b)(4).This report is for an unk - radial head prosthesis/unknown lot.Part and lot numbers are unknown; udi number is unknown.Complainant part is not expected to be returned for manufacturer review/ investigation.Reporter is a j&j representative.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 product was received; 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.
 
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.H3, h6: product was not returned.Based on the information available, it has been determined that no corrective and 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
The patient sustained a work-related injury in 2016 and underwent radial head arthroplasty with a press-fit radial head implant.Patient had developed significant osteolysis and loosening of her implant.Removed the stem and which was loose within the proximal radius canal.
 
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.H3, h4, h6: device history lot part/lot combination is not valid, therefore the dhr could not be completed.If the device is returned or the lot number is confirmed the dhr will be revisited.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: h6: part: 04.402.008s, synthes lot: h044643, supplier lot: n/a, release to warehouse date: 09 march 2016, manufactured by: synthes monument.Images were provided to depuy synthes for evaluation.Visual analysis of the images found that the following: x-ray images show the right elbow joint with a radial head prosthesis implanted in the proximal radius.Figures 1 through 5 show that the head and stem are connected as intended and no issues are visible with the implants.Bone resorption is visible around the stem and at the base of the head and the cortex towards the ulna appears to be thinned and the canal widened over the length of the radial stem implant.The positioning of the implant seen in figures 3 through 5 appears to be correct.Figures 18 through 30 show microscopic images of various surface treatments and textures and are not specific to the implants related to this event.Figures 43 and 44 are photos of an explanted radial head and stem from another individual and are not the implants from this event.All other images in the attachment are representative images from reference materials or test specimens and are not the implants related to this event.As the devices were not returned, an as-received condition could not be assessed, and a dimensional inspection and document/specification review were not completed.As part of depuy synthes quality process, all devices are manufactured, inspected, and released to approved specifications.The overall complaint was confirmed as the bone resorption around the radial stem is visible in the images contained within the report.Based on the investigation findings, it has been determined that no additional corrective and/or preventative action is proposed.Additional monitoring for any potential safety signals will be conducted through complaint trending and other post-market safety surveillance activities.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
Manufacturer (Section G)
MONUMENT
1101 synthes avenue
monument CO 80132
Manufacturer Contact
kate karberg
1302 wright lane east
west chester, PA 19380
3035526892
MDR Report Key12828834
MDR Text Key280895888
Report Number2939274-2021-06729
Device Sequence Number1
Product Code KWI
UDI-Device Identifier10886982128058
UDI-Public10886982128058
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K112030
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Other
Reporter Occupation Other
Remedial Action Recall
Type of Report Initial,Followup,Followup,Followup
Report Date 10/22/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Health Professional
Device Model Number04.402.008S
Device Catalogue Number04.402.008S
Device Lot NumberH044643
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Initial Date Manufacturer Received 10/22/2021
Initial Date FDA Received11/17/2021
Supplement Dates Manufacturer Received03/21/2022
10/26/2022
01/03/2023
Supplement Dates FDA Received04/15/2022
11/16/2022
01/05/2023
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is the Device Single Use? Yes
Type of Device Usage Unknown
Removal/Correction NumberZ-1124-2017
Patient Sequence Number1
Treatment
24 COCR RADIAL HEAD STD HEIGHT/13.0-SILE.
Patient Outcome(s) Required Intervention;
Patient Age72 YR
Patient SexFemale
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