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WRIGHTS LANE: SYNTHES USA PRODUCTS LLC 7MM TI STRAIGHT RADIAL STEM 26MM-STERILE; PROSTHESIS, ELBOW, HEMI-RADIAL, POLYMER
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| Catalog Number 04.402.007S |
| Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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| Patient Problems
Pain (1994); Loss of Range of Motion (2032)
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| Event Date 04/07/2016 |
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Event Type
Injury
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Manufacturer Narrative
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Patient information is unknown.This report is for a radial head - unknown lot.Complainant part has not been returned for manufacturer review/investigation.Without a lot number the device history records review could not be completed.The investigation could not be completed; no conclusion could be drawn, as no product was received.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 a patient underwent a revision of a radial head prosthesis on (b)(6) 2016 due to pain and lack of mobility in their elbow.The radial head prosthesis was initially implanted in the patient on (b)(6) 2015 due to an unknown reason.There is no further information.This complaint involves two (2) devices.This report is for a radial head stem prosthesis.(b)(4).
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Manufacturer Narrative
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Initially reported as (b)(6) 2017 but should have been (b)(6) 2017.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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(b)(4).The investigation could not be completed; no conclusion could be drawn, as no product was received.Initially reported as (b)(6) 2016.Date the device loosened is not known, date of event is not known.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.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 a patient underwent left elbow radial head explantation, left elbow manipulation under anesthesia and left elbow dynamic stress fluoroscopic evaluation on (b)(6) 2016 due to left elbow radial head lucency, loosening of radial head implant stem, pain and lack of mobility.The patient had been implanted with the radial head system on (b)(6) 2015 due to a left elbow dislocation and fracture to radial head on (b)(6) 2015 due to a fall.The patient subsequently developed progressive lucency around the stem of the radial head implant with proximal bone resorption consistent with a loose implant.The patient had been suffering from worsening pain and radiographic signs of loosening had increased.During the removal procedure, general anesthesia and iv antibiotics were administered to the patient, thereby lying the patient in a supine position.Under lateral fluoroscopic imaging, full pronation and supination was applied to the elbow, rotating the forearm, which demonstrated the clinical diagnosis instability of radial head implant stem.While dissecting the operating tissue, the radial head capsule was sharply opened and there was a moderate amount of reactive synovitis in the joint with some mild hemorrhagic component to it.The fluid from the joint, some tissue surrounding the radial head implant and the radial head implant stem with some tissue attached to it were sent for gram stain and cultures.The surgeon first removed the set screw connecting the modular head to the stem, then the radial head was removed successfully, but with some difficulty.The stem was removed very easily as it was observed to be grossly loose and with no obvious signs of any fixation.The surgeon further tested the radial head loosening by moving the patient¿s arm in pronation and supination positions, which showed that the radial head system did not move much with the exception of maximal position of supination at the last 10 degrees or so, thus confirming the gross instability of the radial stem.Fluoroscopy suggested that the medial and lateral collateral ligament structures suggested healing under visual magnification.Due to the healing and medial and lateral ligament stability, the surgeon decided that implanting a longer stemmed radial head device was neither necessary or appropriate.The surgery was then completed successfully with the patient in stable condition, all counts being correct at the end of the case.
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Manufacturer Narrative
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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 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.(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.
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Event Description
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It was further reported that during the implantation procedure on (b)(6) 2015, the patient underwent an open treatment of left elbow dislocation with primary repair of anterior capsular avulsion injury, a left elbow radial head replacement for fracture and a left elbow primary repair of lateral ulnar collateral ligament.Prior to prepping and draping the patient, radiographs of the contralateral wrist in full extension were obtained to ascertain ulnar variance (1-2 mm negative on the injured side) for comparison in case a radial head replacement was required on the surgical side.Once the injury was visible after suitable incision was made, the surgeon found an obvious clear somatic avulsion of the lateral ulnar collateral ligament off the humoral attachment point, but this appeared to be intact distally on the ulna.Radial head fracture showed almost fragments.The surgeon believed that a primary open reduction internal fixation might be the amenable, and hence proceeded to attempt the same with the goal of preserving native bone for the patient.After cleaning the wound site for better visualization of the operating site, the articular surface was lagged back together with two (2) 2.0 mm lag screws, with heads countersunk.This now stabilized the articular blocks, was dis-impacted and then a radial head locking plate was applied.Additional lateral radiographs after the provisional stabilization showed a near-perfect reduction; however, the elbow was with the elbow being fully supinated or at least in neutral position, the surgeon mentions that he underestimated the dis-impaction of the radial neck region.Without realizing this, the surgeon proceeded to stabilize it fully with combination of nonlocking screws in the shaft and locking screws in the head.Upon taking full-rotational images of the radial head in full pronation and supination, the surgeon finally realized that there was still a moderate degree of apex posterior malangulation which caused the anterior portion of the radial head in position of extension and did not provide adequate buttress to prevent posterior subluxation as would be necessary in the face of a multi-ligament elbow dislocation.As per the surgeon, further dis-impaction on the other hand, would have left one side of the radial head with a large fracture gap spanned by this plate construct and this would not be appropriate for the patient.Hence, the surgeon proceeded to provisionally fixate the lateral ulnar collateral ligament.The center rotation of distal humerus was identified and one (1) 3.5 mm arthrex titanium corkscrew was inserted until fully seated in bone.Once this construct was complete, the surgeon again evaluated elbow for stability.With maximal supination and extension, it still wanted to subluxate posteriorly because of the still impacted position of the anterior radial head.Radiographs taken to compare the fractured elbow and the other elbow confirmed that the alignment was not anatomically congruently reduced.Surgeon believed that any further realignment to osteosynthesis of the radial head and neck would be unsatisfactory of the patient and would likely cause nonunion and hence he aborted with the osteosynthesis of the radial neck and head, and further proceeded to radial head replacement.At this point, all implanted hardware was removed.Further, the surgeon restored a symmetric position of the ulnar variance with the contralateral wrist radiographs and to maintain stability of the elbow, he repaired the anterior capsular structures.Finally, the radial head prosthesis was placed in an excellent position and was confirmed with fluoroscopic images.Further, the surgeon proceeded to flex the elbow and tie the anterior capsular structures over the dorsal aspect of the ulna with a compressive load through the ulnar humeral articulation in 90 degrees of elbow flexion.This was tied stoutly down over the dorsal cortex of the ulna with approximately 1 cm cortical bone bridge, which improved the elbow stability by a lot.Medial ligamentous avulsion injuries which were likely present were not repaired by the surgeon since the elbow was grossly stable.More radiographs confirmed minimal anterior subluxation still present and was noticed only with maximal pronation.The surgical wound was then stitched, and procedure completed successfully.After the patient tripped over a trailer hitch and landed on his outstretched left elbow on october 23, 2015, he sustained a terrible triad fracture dislocation.X-rays taken on october 26, 2015 at the emergency department follow-up showed a comminuted left radial head fracture with a slight displacement visible in the ap view, and more displacement visible in the lateral view.Over time, the patient developed progressive lucency around the stem of the radial head prosthesis with proximal bone resorption consistent with a loose implant.The patient¿s pain kept worsening, as did the radiographic signs of loosening.On (b)(6) 2015, the patient presented to the hospital after his fall, and underwent a closed manipulative reduction of his elbow dislocation which was moderately stable after the reduction, particularly when splinted.Subsequently, on an unknown day between (b)(6) 2015 and (b)(6), 2015, the patient presented to the surgeon¿s office with significant displacement and malangulation of the radial head.This predisposed him to recurrent elbow dislocation with early motion.During the explantation procedure on (b)(6) 2019, the patient underwent a left elbow radial head explantation, left elbow manipulation under anesthesia and left elbow dynamic stress fluoroscopic evaluation by the physician.
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