MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC 8MM TI STRAIGHT RADIAL STEM 28MM-STERILE; PROSTHESIS, ELBOW, HEMI-RADIAL, POLYMER

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.

• 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 Key: 12828834
• MDR Text Key: 280895888
• Report Number: 2939274-2021-06729
• Device Sequence Number: 1
• Product Code: KWI
• UDI-Device Identifier: 10886982128058
• UDI-Public: 10886982128058
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K112030
• Number of Events Reported: 1
• 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 Number: 04.402.008S
• Device Catalogue Number: 04.402.008S
• Device Lot Number: H044643
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 10/22/2021
• Initial Date FDA Received: 11/17/2021
• Supplement Dates Manufacturer Received: 03/21/2022; 10/26/2022; 01/03/2023
• Supplement Dates FDA Received: 04/15/2022; 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 Number: Z-1124-2017
• Patient Sequence Number: 1
• Treatment: 24 COCR RADIAL HEAD STD HEIGHT/13.0-SILE.
• Patient Outcome(s): Required Intervention
• Patient Age: 72 YR
• Patient Sex: Female