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WRIGHTS LANE SYNTHES USA PRODUCTS LLC 8MM TI STRAIGHT RADIAL STEM 28MM-STERILE; PROSTHESIS, ELBOW, HEMI-RADIAL, POLYMER
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| Model Number 04.402.008S |
| Device Problem
Device Slipped (1584)
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| Patient Problems
Pain (1994); Swelling (2091); No Code Available (3191)
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| Event Date 01/01/2017 |
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Event Type
Injury
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Manufacturer Narrative
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Date of event reported as an unknown date in 2017.Complainant part is not expected to be returned for manufacturer review/investigation.Reporter is a legal professional.The investigation could not be completed; no conclusion could be drawn, as no product was received.Based on the information available, it has been determined that no corrective and/or preventative action is proposed.This complaint will be accounted for and monitored via post market surveillance activities.If additional information is made available, the investigation will be updated as applicable.A device history record review has been requested.(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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It was reported that on (b)(6) 2017, the patient underwent revision of radial head arthroplasty using a non-synthes device due to loosening of the stem.The surgeon easily removed the set screw in the synthes arthroplasty and removed the head and the stem.The final implant was then opened and impacted into place.The patient was then taken to the recovery room in stable condition.On (b)(6) 2016, patient went to the clinic with complaints of right elbow pain and was found out to have a radial head fracture and left distal radial fracture.On (b)(6) 2016, the patient was implanted with synthes size 8mm stem with a 24mm radial head during radial head replacement.From (b)(6) 2016 to (b)(6) 2017, the patient presented with limited use of right arm due to increased swelling, stiffness, and pain.The patient reported increased pain in the left wrist and intermittent pain in the right elbow.Elbow x-ray on (b)(6) 2017 showed a small amount of loosening over the implant.Elbow x-ray on (b)(6) 2017 showed lucency around the radial head still with appropriate overall length and alignment at the wrist.Elbow x-ray on (b)(6) 2017 showed significant loosening around the stem that was not significantly changed from the previous x-ray.This report is for an 8mm titanium (ti) straight radial stem.This is report 1 of 2 for (b)(4).
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Manufacturer Narrative
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(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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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.An additional product investigation was completed: additional medical images were reviewed, and no device issue was able to be identified.The reported condition of loose was unable to be confirmed.Additional monitoring for any potential safety signals will be conducted through complaint trending and other post market safety surveillance activities.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.The radial stem in the provided medical imaging appears intact with no visual defects.Therefore, the complaint condition of loosening could not be confirmed with the provided information and no definitive root cause was able to be determined.For this compliant, no product defects were identified and no design or manufacturing issues were observed.Since the radial head prosthesis system has been recalled and the complaint condition was investigated through those efforts, no further investigation is required.Additional monitoring for any potential safety signals will be conducted through complaint trending and other post market safety surveillance activities.A corrective and/or preventative action is proposed or already launched.See related actions.Device history lot manufacturing location: supplier - (b)(4) , packaged and released by: monument, manufacturing date: 06-apr-2015, expiration date: 28-feb-2020, part number: 04.402.008s, 8mm ti straight radial stem 28mm ¿ sterile, lot number: 7846010 (sterile).This lot met all dimensional, visual and packaging criteria at the time of release with no issues documented during the manufacture that would contribute to this complaint condition.Component part(s) reviewed: part number: 21014, tialnbri16.00, lot number: 7557656.This lot met all dimensional, visual, sterility and packaging criteria with no issues documented during the inspection or release of the product that would contribute to this complaint condition.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.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.Product investigation was completed based on the review of the provided medical imaging.Devices were not returned for physical evaluation.The radial stem in the provided medical imaging appears intact with no visual defects.The images are dated sep 26.Thus, they are likely from the initial surgery per reported complaint description of ¿on (b)(6) 2016, the patient was implanted with synthes size 8mm stem with a 24mm radial head during radial head replacement due to radial head and neck fracture.¿ therefore, the complaint condition of loosening could not be confirmed with the provided information and no definitive root cause was able to be determined.For this compliant, no product defects were identified and no design or manufacturing issues were observed.The radial head prosthesis system has been recalled and the complaint condition was investigated through those efforts, no further investigation is required.Additional monitoring for any potential safety signals will be conducted through complaint trending and other post market safety surveillance activities.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.Device history lot manufacturing location: supplier - avalign nemcomed / inspected, packaged and released by: monument manufacturing date: 06-apr-2015 expiration date: 28-feb-2020 part number: 04.402.008s, 8mm ti straight radial stem 28mm ¿ sterile lot number: 7846010 (sterile) this lot met all dimensional, visual and packaging criteria at the time of release with no issues documented during the manufacture that would contribute to this complaint condition.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 on (b)(6), 2017, the patient underwent revision of radial head arthroplasty using a non-synthes device due to loosening of the stem.A lateral incision was made down through the previously-made incision and extended just slightly proximal.Blunt dissection was taken down through the subcutaneous tissues, elevating wide skin flaps over the extensor musculature fascia.The edc muscle was split, and the supinator muscle was then seen.The capsule and annular ligament were opened and then the synthes implant was easily seen.Sharp dissection was taken distally down to the level of the existing radial neck with blunt dissection taken down to the supinator muscle, excising the supinator fascia proximally and then splitting the muscle distally in order to ensure that there was no injury to the posterior interosseous nerve, which was not encountered.The surgeon easily removed the set screw in the synthes arthroplasty and removed the head and the stem.The final implant was then opened and impacted into place.The wound was then irrigated gently and inserted the neck and head combo into the radial neck.The patient was then taken to the recovery room in stable condition.On (b)(6) 2016, patient went to the clinic with complains of right elbow pain.It was found out to have a radial head fracture and left distal radial fracture.On (b)(6) 2016, the patient was implanted with synthes size 8mm stem with a 24mm radial head during radial head replacement due to radial head and neck fracture.From (b)(6) 2016 to (b)(6) 2017, the patient presented with limited use of right arm due to increased swelling, stiffness and pain.The patient reported increased pain in the left wrist and intermittent pain in the right elbow.Elbow x-ray on (b)(6) 2017 showed a small amount of loosening over the implant.Elbow x-ray on (b)(6) 2017 showed lucency around the radial head still with appropriate overall length and alignment at the wrist.Elbow x-ray on (b)(6) 2017 showed significant loosening around the stem that was not significantly changed from the previous x-ray.
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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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Event Description
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It was reported that on (b)(6) 2017, the patient underwent a revision of radial head arthroplasty using a non-synthes device due to loosening of the stem.A lateral incision was made down through the previously-made incision and extended just slightly proximal.Blunt dissection was taken down through the subcutaneous tissues, elevating wide skin flaps over the extensor musculature fascia.The edc muscle was split, and the supinator muscle was then seen.The capsule and annular ligament were opened and then the synthes implant was easily seen.Sharp dissection was taken distally down to the level of the existing radial neck with blunt dissection taken down to the supinator muscle, excising the supinator fascia proximally and then splitting the muscle distally in order to ensure that there was no injury to the posterior interosseous nerve, which was not encountered.The surgeon easily removed the set screw in the synthes arthroplasty and removed the head and the stem.The final implant was then opened and impacted into place.The wound was then irrigated gently and inserted the neck and head combo into the radial neck.The patient was then taken to the recovery room in stable condition.On (b)(6) 2016, patient was involved in a cycling accident where he flipped over the handle bars landing on bilateral outstretched arms.The patient went to the clinic with complains of right elbow pain.The patient was found to have a radial head fracture and left distal radial fracture.From september 19, 2016 to september 21, 2016, the patient went to the clinic with left wrist and right elbow fractures from a bike accident on (b)(6) 2016 and complained of muscular pain, pain with range of motion, and abrasion to the right arm.Radiographs showed a displaced radial head fracture as well as a radial styloid fracture of the left wrist.On (b)(6) 2016, the patient was implanted with synthes size 8mm stem with a 24mm radial head during radial head replacement due to radial head and neck fracture.From october 07, 2016 to august 11, 2017, the patient presented with limited use of right arm due to increased swelling, stiffness and pain.The patient reported increased pain in the left wrist and intermittent pain in the right elbow.Elbow x-ray on (b)(6) 2017 showed a small amount of loosening over the implant.Elbow x-ray on (b)(6) 2017 showed lucency around the radial head still with appropriate overall length and alignment at the wrist.On (b)(6) 2017, the patient was having a little bit of soreness in the elbow when he does a lot of weightlifting.An mri showed that he had an abnormal appearance of the triangular fibrocartilage consistent with a tear.Elbow x-ray on (b)(6) 2017 showed significant loosening around the stem that was not significantly changed from the previous x-ray.On (b)(6) 2017, the patient went to the clinic and complained that he was beginning to have more wrist and elbow pain and beginning to click a little bit as well.Radiograph showed significant loosening around the stem that has not significantly changed.
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