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 Unintended Movement (3026)

Patient Problems Pain (1994); No Code Available (3191)

Event Type  Injury  

Manufacturer Narrative

Date of event is unknown.Device is not expected to be returned for manufacturer review/investigation.Device evaluation/investigation could not be completed; no conclusion could be drawn as product was not returned to manufacturer.Device history records review is 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 the patient underwent arthroplasty procedure and was implanted with the radial head prosthesis on (b)(6) 2016.Patient underwent a removal of a radial head prosthesis on (b)(6) 2017 due to severe pain and losing functionality and mobility in the arm for about one month before the revision.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.Patient reportedly have painful stiff elbow.Unknown number of x-rays were taken at an unknown time showed thinning of bone around the radial head implant.Initial implant and revision surgeries were both conducted by the same surgeon.The patient decided to go for the removal/revision surgery after they heard about the recall on the product.The patient was notified of the current recall on radial head by the surgeon.During the removal surgery, both the radial head and stem were removed from the patient and that the radial stem was not retaining to the bone, or in other words, radial stem was loose.The surgery was completed successfully without any complications and patient consequence.The patient reported not feeling as much pain after the removal.Concomitant devices reported: radial head (part # 09.402.022s, lot # 7855823, quantity # 1).This report is for one (1) 7mm ti curved radial stem 42mm-sterile.This is report 1 of 1 for (b)(4).

Manufacturer Narrative

Dhr review was completed.Manufacturing location: (b)(4), packaged by: (b)(4) manufacturing date: 09-apr-2013 expiration date: 28-feb-2018 part #: 04.402.027s, lot#: 7012314 (sterile) - 7 mm ti curved radial stem 42mm-sterile.Quantity 39.Raw material part no: 21069 lot number 5490857 reviewed.Inspection sheet for incoming final inspection meet inspection criteria.Certificate of compliance from (b)(4) for (b)(4) meet specification.No ncrs were generated during production.Review of the device history record(s) showed that there were no issues during the manufacture of the product that would contribute to this complaint condition.¿sterility documentation was reviewed and determined to be conforming.¿ 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

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

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

Further it was reported that 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.Multiple x-rays suggested that the gap between the hardware and bone was increasing, and hence, on (b)(6) 2017, the surgeon removed the hardware.A revision to another radial head device was not possible due to the bone being extremely thin in the area, and the surgeon was unable to pack the hole left by the hardware with bone graft.The patient reports currently attending physical therapy to regain the range of motion and strength.

Manufacturer Narrative

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 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

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

Additional narrative: patient's height reported as (b)(6).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

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

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.Additional narrative: 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 removal of a radial head prosthesis on (b)(6)2017 due to severe pain and losing functionality and mobility in the arm for about one month before the revision.The patient had fallen on an unknown date and sustained multiple injuries/fractures.Following this, 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.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.Laboratory results for routine histology and cytology dated (b)(6) 2017 for post-implant tissue evaluation after explantation of the radial head implant suggested fragments of fibro-collagenous and synovial tissue with acute and chronic inflammation, but no infection.Patient underwent removal of radial head prosthesis on (b)(6) 2018 due to pain and loosening of the implant.The surgeon discovered during the procedure that the implant was very loose and was able to remove the implant without disengaging the head from the stem.Intra-operative fluoroscopy confirmed that the cortical thinning had worsened since after the post-implantation (post-operative) x-rays.The patient awoke without any complication after the procedure, procedure was completed successfully, and was reported to have been taken out of the operating room (or) in a stable condition.As reported on a follow-up visit on (b)(6) 2018, the patient still feels mild pain present on ascent and descent and is able to perform other exercises well with mild pain and intermittent pain with strengthening.Patient has had a better range of motion lately.Concomitant devices reported: unknown radial head (part # 09.402.022s, lot # 7855823, quantity # 1).

• 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: 7155551
• MDR Text Key: 96110078
• Report Number: 2939274-2017-50496
• Device Sequence Number: 1
• Product Code: KWI
• UDI-Device Identifier: 10886982128096
• UDI-Public: (01)10886982128096(17)EXPIRATIONDATEUNKNOWN(10)7012314
• 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,health
• Remedial Action: Recall
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date: 12/01/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/29/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• 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
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 51 YR
• Patient Weight: 100