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SYNTHES MONUMENT 20MM COCR RADIAL HEAD STANDARD HEIGHT/12.0MM-STERILE; PROSTHESIS, ELBOW, HEMI-RADIAL, POLYMER
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| Catalog Number 09.402.020S |
| Device Problems
Break (1069); Device Slipped (1584); Adverse Event Without Identified Device or Use Problem (2993)
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| Patient Problems
Failure of Implant (1924); Pain (1994); No Code Available (3191)
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Event Type
Injury
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Manufacturer Narrative
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Date of event is unknown.This report is for one (1) unknown radial head.Part#, lot# and udi # is not available.Device is not expected to be returned for manufacturer review/investigation.Event was reported by patient.Contact number of surgeon: (b)(6).This report is for one (1) unknown radial head.Pma/510(k) number is not available.(b)(4).Device evaluation/investigation could not be completed; no conclusion could be drawn as product was not returned to manufacturer.Device history records review could not be completed without lot number.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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Event Description
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It was reported that the patient underwent initial implant procedure on (b)(6) 2017.Patient was implanted with radial head prosthesis.Post operatively, patient started experiences pain approximately in (b)(6) 2017.X-rays were taken on a follow-up visit to the surgeon in (b)(6) 2017.The surgeon informed the patient that the device was broken in half and that she would need surgery.Patient is unaware of where the implant is reportedly broken.The patient underwent removal of the devices on (b)(6) 2017; they were not replaced.The patient was still experiencing pain and swelling in the elbow and decreased range of motion.This report is for one (1) radial head.This is report 1 of 2 for (b)(4).
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Manufacturer Narrative
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Udi: (b)(4).A device history record (dhr) review was performed for part: #09.402.020s, synthes lot #h032195: release to warehouse date:12feb2016, expiration date: january 31, 2021, supplier: avalign nemcomed: no non-conformance reports (ncrs) were generated during production.Review of the device history records showed that there were no issues during the manufacturing of this product that would contribute to this complaint condition.(b)(4).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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Event Description
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Preoperative and postoperative diagnosis was reported as a closed comminuted displaced right radial head fracture and right posterior interosseous nerve palsy.The name of the procedures that was performed was a right radial head arthroplasty and right posterior interosseous nerve neurolysis.Patient sustained an injury to elbow when fell at home.Patient initially presented to an emergency department.Patient was noted to have loss of wrist and digital extension and was provided a sling.Patient then presented to the surgeon office several weeks later and reported that the active wrist extension had improved, but still had persistent weakness in her ring with extension on her ring and small fingers.Patients x-rays as well as an mri scan have demonstrated a comminuted multipart displaced fracture of the radial head.Surgeon recommended a right radial head arthroplasty and right posterior interosseous nerve neurolysis.Initial surgery was completed successfully using general anesthesia with no apparent complications.Operative report from removal surgery on june 27, 2017 states that the diagnosis and indications for procedure for this procedure are failed right radial head arthroplasty with closed proximal radius periprosthetic fracture.Name of the removal procedure is an open removal of right radial head implant.Postoperative, the patient had been doing well with the implant until she was doing some gardening and felt a pop in her elbow when she was lifting an object.Patients x-ray demonstrated significant lucency around the implant consistent with failure of osseointegration and there was an associated periprosthetic fracture of the proximal radius.Surgery was completed successfully with no apparent complications and patient was reported in stable condition.Originally patient reported that the implant had broken in half.As per the operative reports, no mention was made of the implant being broken.Reason for removal was due to patient falling and significant lucency around the implant consistent with failure of osteointegration and there was an associated periprosthetic fracture of the proximal radius.
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Manufacturer Narrative
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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: event, relevant tests/laboratory data, other relevant history.The x-rays were reviewed, and the complaint cannot be confirmed.Relevant actions have been initiated to address this issue.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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Event Description
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It was reported that the initial injury to the patient¿s right elbow occurred on (b)(6) 2016, where the patient suffered a displaced right radial head fracture and injury to the posterior interosseous nerve.The patient was initially evaluated by the surgeon on (b)(6) 2016.On (b)(6) 2016, the patient had an uncomplicated procedure were the patient was implanted with a radial head prosthesis implant.The patient had a routine postoperative course and underwent physical therapy after surgery.The patient was doing very well with respect to the elbow until early june 2017.It was later reported that as the patient was performing routine gardening activities, she picked up a tomato plant and felt a ¿crack¿ around her right lateral elbow and felt immediate pain with increasing swelling and some bruising around the right elbow.The patient then returned for an office visit on (b)(6) 2017.Right elbow x-rays were taken, and if was found the patient had notable extensive osteolysis and thinning of the bone around the radial head prosthesis with a periprosthetic fracture of the radius bone around the prosthesis.Implant removal surgery was performed on (b)(6) 2017.During this procedure, the surgeon reported that the radial head implant was completely loose and was easily removed from the wound.There was evidence of bone loss with significant thinning of the bone around the proximal radius around the area of the prosthesis.There was a fracture through the bone in this thinned area.Overall, this appeared consistent with the failure of the radial head implant to osteon-integrate into the bone.Observed intra-operative, changes appeared consistent with bone boss and osteolysis due to a loose implant.In the surgeon¿s opinion, the periprosthetic radial head fracture from on (b)(6) 2017 revision elbow surgery was necessitated by the failure of the radial head implant.The implant was designed to osteo-integrate into the proximal radius bone.However, based on the x-ray and intra-operative findings, clearly the radial head implant failed to heal into the bone properly.This caused loosening of the implant with substantial weakening of the bone.The patient sustained a fracture by picking up a garden plant; this is considered a very low energy mechanism of injury.Such a low energy mechanism could only be caused by a bone which was substantially weak.In this case, the patient's bone was weakened and thinned due to the failed oseo-integration of the radial head implant.Post-operative, on (b)(6) 1017, during an office visit physical exam, the patient was notable for loss of range of motion, specifically with full rotation of the forearm (pronation and supination) and loss of flexion and extension of the elbow.X-rays taken during this office visit found demonstrated satisfactory removal of the radial head implant with bone fragmentation on the proximal radius at the site of the periprosthetic fracture.It was reported that after the first surgery, the implant that was placed in patient¿s right elbow functioned quite well, with full range of motion.After the follow-up revision surgery, the patient reported with loss of ten percent of her forearm pronation and ten percent supination well as.The patient is still experiencing pain around the elbow due to the surgery and removal of the implant.The patient is expected to have permanent weakness and decreased endurance with use of the right elbow because of the revision surgery.The patient will require some medical treatment to address the right elbow issues, with periods of increased pain and flare-ups due to increased activity that will require rest for 2-7 days, physical therapy and medication treatment.
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Manufacturer Narrative
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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.
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Manufacturer Narrative
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Depuy synthese is submitting this report pursuant to the provisions of 21 cfr, part 803.This report may be based on information which depuy synthese has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, depuy synthese or its employees that the report constitutes an admission that the device, depuy synthese, 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.H10 additional narrative: a5; b5; b6; b7, g3.H6: added patient code h11 corrected data: a4.H6: corrected device problem code.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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Event Description
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Updated event description: it was reported that on june 27, 2017, the patient underwent a removal of implant due to failed radial head arthroplasty with associated closed, nondisplaced periprosthetic fracture of the proximal radius.On (b)(6) 2016, the patient tripped over the dishwasher door in the dark and sustained a closed nondisplaced fracture of head of right radius.She experienced immediate pain and swelling and limited mobility about the right elbow.She went to the emergency department on (b)(6) 2016 and an x-ray was taken revealing an impacted fracture of the right radial neck and right elbow effusion.She was placed in a sling and was given a pain reliever.She was advised to obtain a follow up with her orthopedics and her primary physician.The patient states that while in the urgent care setting she experienced difficulty in digital extension involving index, ring, long and little fingers of the right hand.The patient reports that no mention of possible nerve impairment or injury was made during her diagnostic urgent care evaluation.On (b)(6) 2016, the patient's injury was initially evaluated by her primary orthopedic surgeon.On physical exam, the patient has digital extension deficit which is evolving.X-rays demonstrate a displaced, comminuted radial head fracture with an extruded fragment.The patient has digital extension deficit which is evolving.This extension deficit suggests a trauma-related injury to the posterior interosseous nerve.She was referred to an upper extremity specialist for the management of the comminuted radial head fracture with displacement and fragment extrusion.On (b)(6) 2016, she went to see the surgeon she was referred to.It was found out upon interview that she was apparently told, that this was a relatively minor injury and would heal expectantly in about 4-6 weeks.Also, she notes that immediately following the injury she lost the ability to straighten out her fingers.Since the injury, she has had significant pain, stiffness and swelling around the right elbow.Gradually, she has regained the ability to extend her index and middle fingers, but she still had difficulty with the ring and small fingers.Due to the severity of the injury, surgery was recommended.On (b)(6) 2016, the patient underwent an uncomplicated right radial head arthroplasty, right posterior interosseous nerve neurolysis where a synthese radial head prosthesis was used.Follow-up visits follows a week after on (b)(6) 2016.The patient stated that she feels a lot better than she did prior to surgery.She still has limited ability to extend her ring and small fingers but had no difficulty with wrist or digital extension in the other digits.No numbness or tingling about the hand.She was advised to do a physical therapy.On (b)(6) 2016, the patient stated that she already started her therapy.She had slightly improved extension in her fingers and no numbness or tingling in the hand.The patient was doing well with respect to the elbow surgery until early (b)(6) 2017.While she was doing a routine gardening activity and when she picked up a tomato plant, she felt a crack around her right lateral elbow and felt immediate pain.She also noted increasing swelling and some bruising around the right elbow.She then went to see her surgeon on (b)(6) 2017.Right elbow x-rays at that visit were notable for extensive osteolysis and thinning of the bone around the radial head prosthesis with a periprosthetic fracture of the radius bone around the prosthesis.Treatment options were reviewed at that time, and surgical removal of the radial head implant was recommended.On (b)(6) 2017, the patient underwent an open removal of right radial head implant.During the procedure, hemorrhagic synovitis was encountered from the joint and evacuated.The radial implant was then identified.It was clearly loose, and it was rotated.The screw was identified and loosened.The head piece was then easily removed, and following this, the proximal radius stem was then removed.There was no evidence of purulence in the wound.Her last follow-up appointment was october 12, 2017, where she reported to have weakness in the elbow and continued discomfort.Her physical exam was notable for loss of range of motion, specifically with full rotation of the forearm (pronation and supination) and loss of flexion and extension of the elbow.X-rays of the right elbow demonstrated satisfactory removal of the radial head implant with bone fragmentation on the proximal radius at the site of the periprosthetic fracture.
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