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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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| Model Number 04.402.007S |
| Device Problems
Device Slipped (1584); Unintended Movement (3026)
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| Patient Problems
Osteolysis (2377); No Code Available (3191)
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Event Type
Injury
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Manufacturer Narrative
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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 review of the device history records 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 the patient underwent a removal of left radial head prosthesis.A 2.2 cm cystic area of osteolysis within the truncated proximal radius corresponds to an area of prosthesis loosening on prior radiographs.There is no adjacent marrow edema currently.Surgical outcome and patient status were not reported.This report is for one (1) 7mm ti straight radial stem 26mm-sterile.This is report 1 of 1 for (b)(4).
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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 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 removal of implant and lateral collateral ligament tightening and repair at the epicondyle due to left elbow arthritis with a loose implant with apparent synovitis.There was no evidence of infection.The set screw was loosened, and the implant head was removed.The implant stem was then removed.A light debridement was carried out, removing all loose synovitis.The wound was copiously irrigated.The collateral ligament was slightly lax due to loss of the mass effect of the implant.As such, a running locking tightening repair was carried out of the collateral ligament complex.This was done without complication.The patient was taken to the recovery room in stable condition.There were no intraoperative complications.On (b)(6) 2015, the patient complained of left elbow pain.X-rays taken showed that there was a radial head fracture noted.On (b)(6) 2015, the patient was implanted with synthes radial head replacement with size 7 stem, +2 neck, and 22mm diameter head during open reduction of dislocated elbow with radial head replacement and lateral collateral ligament repair due to dislocation of radial neck fracture and collateral ligament injury.Elbow x-ray taken at follow-up on (b)(6) 2015, 3 views showed good alignment of her elbow and radial head replacement.On (b)(6) 2015, the patient went to the clinic for follow up.The patient was doing well but range of motion for elbow was 125 to 35 in terms of flexion /extension and had near supination, but pronation was still a little bit limited.Elbow x-ray showed some heterotopic ossification noted both medially as well as the radial head.On (b)(6) 2015, the patient went for follow up.The patient was doing well but had some issues in terms of ulnar nerve symptoms and a little bit of shoulder pain.No heterotopic ossification upon elbow x-ray.On (b)(6) 2015, the patient expressed concerns about residual stiffness in the left elbow, numbness/tingling in the left ring/small fingers (and ulnar palm), and pain in the left shoulder.There was mild swelling around the elbow upon physical examination.Pain in the left shoulder was elicited with impingement maneuvers.Upper extremity electrodiagnostic study revealed left ulnar palsy at the elbow and mild ulnar and median motor slowing in the forearm.Emg on (b)(6) 2015 revealed left ulnar palsy at the elbow with significant neuropraxia and some evidence of degeneration.Mild ulnar and median motor slowing through the left forearm, etiology is unclear.On (b)(6) 2015, the patient went for follow up with complaints of any pronation bothers numbness, sore stiff fingers especially the little finger, sore point of elbow and sore stiff wrist.Shoulder mri on (b)(6) 2015 revealed partial thickness bursal-sided insertional tearing of the mid and posterior fibers of the supraspinatus tendon superimposed on mild tendinosis, limited subacromial bursitis, thickening of the inferior glenohumeral ligament with edema, consistent with adhesive capsulitis and prominent axillary lymph nodes.On (b)(6) 2015, the patient reported an improvement in shoulder motion in association with physiotherapy measures.The patient described residual pain in the left upper arm and posterior left elbow, in addition to tingling/numbness in the left forearm/small finger.On (b)(6) 2016, the patient was doing well overall.Elbow x-ray showed good alignment of the radial head prosthesis and worsening of the heterotopic ossification.On (b)(6) 2016, the patient returned for evaluation of left shoulder pain, elbow stiffness/tingling in the hand (palm and ulnar 2 digits).Upon physical examination, there was mild residual swelling around the elbow.Elbow x-ray on (b)(6) 2016 showed heterotopic ossification seems to be more organized and appeared to be basically resolved.On (b)(6) 2016, the patient still experienced occasional sharp pains radiating down the radial side of her arm.On (b)(6) 2017, the patient went for follow up with some complaints regarding strength and loss of motion.On (b)(6) 2017, the patient requested therapy and complained of pain.On (b)(6) 2017, the patient went for follow up with complaints of left arm pain.The patient was still having sharp pains and ¿popping/grinding¿ in left forearm/elbow/thumb sensations when performing certain tasks.Elbow x-ray taken on (b)(6) 2017 revealed a radial head arthroplasty with significant expansion of the radial neck with some osteolysis at the radial neck implant junction.Status post radial head arthroplasty with marked circumferential lucency surrounding the radial stem component, compatible with osteolysis and loosening.Elbow molecular resonance imaging (mri) on (b)(6) 2017 revealed findings consistent with loosening of the radial head arthroplasty.On (b)(6) 2017, the patient stated noted a new onset of pain and a change in symptoms.They felt more forearm pain, sharp in nature which radiates to her thumb.The pain was becoming more persistent with movement, and pain at rest as well.The patient also had onset of ulnar nerve symptoms.X-rays were reviewed and demonstrated lucency surrounding the radial stem implant.On (b)(6) 2017, the patient presented for a second opinion regarding her left elbow and forearm soreness.The patient was told that the implant loosened and was recommended that the implant be removed.Elbow mri revealed loosening of the radial head implant.Concomitant devices: radial head (part: 09.402.222s, lot: 7608124, quantity: 1).
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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.One radial stem (part 04.402.007s | lot 7654215) was reported with the complaint condition that ¿elbow mri revealed loosening of the radial head implant.¿ the device was not returned for physical evaluation.The following investigation is based on review of the provided medical imaging.Device evaluation: investigation type: picture investigation the device in the provided medical imaging appears intact with no visual defects.Images from the initial surgery were not provided for reference so loosening is difficult to definitively determined.However, one of the attachments appears to show a gap between the radial head implant and bone which is consistent with loosening.Thus, the complaint condition is conservatively considered confirmed.No definitive root cause was able to be determined.However, the radial head prosthesis system (rhp system) was recalled under recall# 555531.Any related investigations and assessment of the risks associated with this system will be covered under recall# 555531 and hhe-2016-180 investigations.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.Relevant actions have been taken to address the 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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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 history lot: manufacturing location: supplier - avalign nemcomed/inspected, packaged and released by: monument.Release to warehouse date: 07-nov-2014.Expiration date: 30-sep-2019.Part number: 04.402.007s, 7mm ti straight radial stem 26mm ¿ sterile.Lot number: 7654215 (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: 6190711.Checklist met all inspection acceptance criteria.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.The device in the provided medical imaging appears intact with no visual defects.Images from the initial surgery were not provided for reference so loosening is difficult to definitively determined.Complaint condition is conservatively considered confirmed.No definitive root cause was able to be determined.However, the radial head prosthesis system (rhp system) was recalled under recall.Any related investigations and assessment of the risks associated with this system will be covered under recall.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 action.Device history lot: manufacturing location: supplier - (b)(4)/ inspected, packaged and released by: (b)(4).Release to warehouse date: 07-nov-2014.Expiration date: 30-sep-2019.Part number: 04.402.007s, 7mm ti straight radial stem 26mm ¿ sterile.Lot number: 7654215 (sterile).Component part(s) reviewed: part number: 21014, tialnbri16.00.Lot number: 6190711.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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