MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC 7MM TI CURVED RADIAL STEM 42MM-STERILE; PROSTHESIS, ELBOW, HEMI-RADIAL, POLYMER

Model Number 04.402.027S

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Pain (1994); Swelling (2091)

Event Type  Injury  

Manufacturer Narrative

Patient¿s height is reported as 5 feet 9 inches.Date of event: date of postoperative pain and swelling development is unknown.Complainant part is not expected to be returned for manufacturer review/investigation.The investigation could not be completed; no conclusion could be drawn, as no product was received.A review of the device history records has been requested and is currently pending completion.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 underwent a us bursa aspiration and attempt joint aspiration procedure on (b)(6) 2017 due to right elbow pain and swelling.The patient initially suffered a radial head fracture when he fell about fifteen (15) feet from a ladder on (b)(6) 2016.Patient stated that they ¿rode a ladder¿ when the foot of the ladder lost traction, causing the ladder to slide down the side of the house.Subsequently, the patient presented to the hospital the next day, and upon follow-up on (b)(6) 2016, a computer tomography (ct) scan and multiple x-ray images of the right elbow confirmed a radial head fracture.The patient was also diagnosed with an avulsion fracture of the left ankle, adjacent to the talus, contusion, abrasions and tarsal fracture.Patient presented with symptoms of pain, swelling and bruising after the fall.Following this, the patient was initially implanted with a radial head and stem construct on (b)(6) 2016 to treat a radial head fracture.The surgeon, during a follow-up visit on an unknown date noticed some space between the hardware and the bone.Gradually, the patient developed increased pain, decreased range of motion, swelling and inability to use the right arm for any activities despite aggressive physical therapy.The patient is right handed.Unknown number of x-rays were taken at an unknown time showed thinning of bone around the radial head implant.After the initial implant of radial head prosthesis on (b)(6) 2016, the patient developed a postop contracture and had sustained a central post-traumatic tfcc tear to the right wrist on an unknown date.On (b)(6) 2017, the patient underwent an arthroscopy of the right wrist with tfcc debridement and manipulation of right elbow under anesthesia.After debriding the large degenerative central tear which was elliptical in nature along the tfcc meniscal disc, radiofrequency ablator was used to finish the debridement.After stitching the portals with a simple monocryl stitch, post-operative analgesia was provided.Before dressing application, a gentle manipulation was performed to the elbow.The surgeon was able to bring the patient to within 5 degrees of extension and approximately 140-150 degrees of flexion.Gentle pressure was applied close to the axis of rotation.The surgery was completed successfully and without any complications.The patient was reported to have been transferred into the short procedure room in stable condition.Subsequently, upon evaluations on (b)(6) 2017 and (b)(6) 2017, the patient still complained of medial wrist pain and elbow tightness.The surgeon also suggested that the patient used their arm a lot over the weekends, suggesting that the patient was non-compliant.Surgeon has reportedly asked the patient to rest their arm during at least one follow-up.During a post-operative follow-up on (b)(6) 2017, a review of radiographic images and found a mild to moderate effusion in the elbow which was surrounding soft tissue edema.This is when the surgeon advised the patient about removing the radial head implant and possibly revising it, however the patient¿s arms were too swollen at that time.Following this, on (b)(6) 2017, the patient underwent the us bursa aspiration and attempt joint aspiration procedure.During this procedure, the skin site was prepped with 2% chlorhexidine solution and left dry for at least three minutes before initiating the aspiration.It was found that there was minimal fluid from the bursa aspirate.The patient was transferred into the short procedure room in stable condition.Further, the patient underwent the removal of the prosthesis and the surgeon realized during the procedure on (b)(6) 2017 that the radial head implant was very loose, and the surgeon was able to remove this completely.This complaint captures the us bursa aspiration and attempt joint aspiration conducted due to right elbow pain and swelling on (b)(6) 2017.(b)(4) is for post-operative arthroscopy of the right wrist with tfcc debridement and manipulation of right elbow under anesthesia on (b)(6) 2017.(b)(4) is for the loosening and removal of radial head prosthesis on (b)(6) 2017.This report is for one (1) 7mm ti curved radial stem 42mm-sterile.This is report 1 of 2 for complaint (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.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.Part: 04.402.027s; synthes lot: 7012314; supplier lot: na; release to warehouse date: april 09, 2013; expiration date: february 28, 2018; manufactured by synthes monument.The raw material was confirmed to be correct per the specification with no (relevant) non-conformance noted.No nonconformance reports (ncrs) were generated during production.Customer quality investigation: the radial head is part of the radial head prosthesis system intended for primary and revision joint replacement of the radial head.The loosening of radial head prosthesis and the removal of the same has been reported under (b)(4) and is captured as a related incident.However, the device was not returned.Instead investigation will be performed based off the x-rays provided.Both of the x-rays provided showed no evidence of device implantation at the time of the imaging and appear consistent with imaging taken post implant removal.Therefore, with the given images, the pain condition being investigated under this complaint (b)(4) was not able to be confirmed.As the device was not returned, the exact part and lot numbers are unknown.However, device history record (dhr) review performed on the provided part and lot number information showed no material review reports (mrrs), ncrs, or actions related to the complaint condition were generated during production.Review of device history record(s) showed that there were no issues during the manufacture of the product(s), which would contribute to the complaint condition.The material properties of the returned part(s) were determined to be conforming at the time of manufacture.The radial head drawings for the reported part number were reviewed and no design issues were identified.Dimensional analysis was not able to be performed on the relevant device as device was not returned.However, the radial head prosthesis system (rhp system) which may have impacted the pain condition was recalled under recall# 555531.Any related investigations and assessment of the risks associated with this system will be covered under recall# 555531 and hhe-2016-180 investigations.This complaint will be accounted for and monitored via post-marketing surveillance activities.If additional information is made available, the investigation will be updated as applicable.The complaint condition was not able to be confirmed based off the available information.During the investigation, no unidentified product design/manufacturing issues or discrepancies were observed (based on the image) that may have contributed to the complaint condition.Based on the investigation findings, it has been determined that no corrective and/or preventative action is proposed.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.

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 further reported that patient reported stiffness in the wrist and elbow and pain in the ankle while walking on (b)(6) 2016.Pain was reported in the triceps tendon on (b)(6) 2016 and stiffness and soreness persist to elbow.Exacerbation of tightness and pain to post elbow at triceps tendon and medial forearm reported on (b)(6) 2017.On (b)(6) 2017, tightness remains to elbow but has decreased.Pain to elbow has ceased but present along medial wrist.On (b)(6) 2018 it was reported right elbow stiffness remains with minimal pain.On (b)(6) 2018 an ultrasound revealed no cystic lesions or loose bodies.Cystic tendon was identified.Ulno-carpal joint was identified, and needle inserted under ultrasound guidance.

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.

• 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 Key: 7895634
• MDR Text Key: 120964550
• Report Number: 2939274-2018-53895
• Device Sequence Number: 1
• Product Code: KWI
• UDI-Device Identifier: 10886982128096
• UDI-Public: (01)10886982128096
• Combination Product (y/n): N
• PMA/PMN Number: K112030
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,other
• Remedial Action: Recall
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date: 06/25/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/20/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 02/28/2018
• Device Model Number: 04.402.027S
• Device Catalogue Number: 04.402.027S
• Device Lot Number: 7012314
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 11/14/2018
• Removal/Correction Number: Z-1124-2017
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 51 YR
• Patient Weight: 100