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 Problem No Code Available (3191)

Event Type  Injury  

Manufacturer Narrative

Patient¿s height reported as 5 feet 9 inches.Complainant part is not expected to be returned for manufacturer review/investigation.Patient code (b)(4) used to capture additional medical/surgical intervention required: patient developed post-operative elbow contracture and required manipulation of right elbow under anesthesia on (b)(6) 2017.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 an arthroscopy of the right wrist with tfcc debridement and manipulation of right elbow under anesthesia on (b)(6) 2017 as they had developed a postop elbow contracture and had sustained a central post-traumatic tfcc tear to the right wrist on an unknown date.The patient was initially implanted with a radial head and stem construct on (b)(6) 2016 to treat a radial head fracture.As per the patient¿s account, the shaft (radial stem) was not retaining to the bone and was causing more damage to the bone than help support it.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.This report addresses post-operative elbow contracture and manipulation of right elbow under anesthesia on (b)(6) 2017.The loosening of radial head prosthesis and the removal of the same has been reported under (b)(4).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.

Event Description

Update to event description: further, it was reported that 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.

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.Additional narrative: expiration date.Device evaluated by mfr: a device history record (dhr) review was conducted for part # 04.402.027s, synthes lot # 7012314, supplier lot # na: release to warehouse date: 09apr2013, expiration date: 28feb2018, manufactured by synthes monument: the raw material was confirmed to be correct per the specification with no (relevant) non-conformance noted.No non-conformance reports (ncrs) were generated during production.Review of the device history record(s) showed that there were no issues during the manufacture of this product, and any sub-components, which would contribute to this complaint condition.The implant was not returned and instead investigation is performed based on the supplied x-rays.Both images were reviewed and the complaint condition of tfcc debridement and manipulation of right elbow could not confirmed based on the images provided.As the implant was not returned an as received, dimensional, material or drawing reviews are not applicable.A dhr review for the manufacturing records and the material records could not be performed as the lot number is unknown.No definitive root cause was able to be determined as the circumstances surrounding the event are unknown.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.If the information is unknown, not available or does not apply, the section/field of the form is left blank.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 on (b)(6) 2016.Pain was reported in the triceps tendon on (b)(6) 2016.Exacerbation of tightness and pain to post elbow at triceps tendon and medial forearm reported on (b)(4) 2017.On (b)(6) 2017, tightness remains to elbow but has decreased.Pain to elbow has ceased but present along medial wrist.On (b)(4) 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.

• 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: 7716617
• MDR Text Key: 114933845
• Report Number: 2939274-2018-53071
• 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: company representative,consum
• 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: 07/24/2018
• 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: 10/30/2018
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 51 YR
• Patient Weight: 100