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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 09.402.026S |
| Device Problem
Unintended Movement (3026)
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| Patient Problems
Erythema (1840); Unspecified Infection (1930); Pain (1994); Swelling (2091); Osteolysis (2377); No Code Available (3191)
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Event Type
Injury
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Manufacturer Narrative
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Complainant part is not expected to be returned for manufacturer review/investigation.Surgical/medical intervention.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.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) 2018, the patient underwent removal of implant, deep, upper extremity because of worsening elbow pain and radiograph evidence of severe osteolysis around the implant.On (b)(6) 2016, the patient underwent radial head arthroplasty using a 7mm straight radial stem and a 26mm cocr radial head on his left elbow.He suffered a fall and sustained a left radial head fracture.On (b)(6) 2016, the patient's sutures were removed and his left arm was splinted.On (b)(6) 2018, the patient suffered worsening of elbow pain and radiograph evidence of severe osteolysis around the implant.There was also loosening of the radial head prosthesis.On (b)(6) 2018, the patient underwent radial head arthroplasty using a radial head prosthesis on his left elbow.An incision was made over the lateral elbow in line with the previous incisional scar.Dissection of the soft tissues was performed with bovie electrocautery.Sutures in the fascia were identified and removed.The fascia was dissected sharply with tenotomy scissors and the interval between ecrb and edc identified.The joint capsule was incised, and the annular ligament was also incised.The radial head prosthesis was then visualized.The screw connecting the radial head component to the stem was loosened and removed, allowing for staged removal of first the head and then the stem.The wound was then irrigated with 3l normal saline.Powdered vancomycin and tobramycin was placed into the wound.The annular ligament was closed with 2-0 pds suture.The interval between edc and ecrb was closed with 0 vicryl sutures in a simple interrupted fashion.The more superficial layers were closed with 2-0 vicryl sutures in inverted simple interrupted fashion and the skin was closed with 3-0 nylon vertical mattress sutures.The wound was dressed in xeroform, 4 x 4s, an abd, and then wrapped with kerlix and an ace bandage.On (b)(6) 2018, the patient went back to the emergency room because of pain and redness.The wound was tender, swelling and has erythema.The patient was given steroids to help with the swelling and keflex for concern of infection.The patient was discharged and was given instructions to apply ice for thirty (30) minutes, four (4) times a day for three (3) days.This is report 2 of 2 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.A review of the device history record has been requested.Product code: 04.402.007s, lot #: h044642, quantity: 1.Actual device was not returned; us customer quality will conduct investigation based on the images provided.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.A review of the device history record device history lot manufacturing location: supplier ¿ (b)(4) / inspected, packaged and released by: monument release to warehouse date: 09-mar-2016 expiration date: 28-feb-2021 part number: 04.402.007s, 7mm ti straight radial stem 26mm-sterile lot number: h044642 lot quantity: (b)(4).Work order traveler met all inspection acceptance criteria.Inspection sheet, incoming final inspection, met all inspection acceptance criteria.Certificate of compliance supplied by (b)(4).Dated 10-feb-2016 was reviewed and determined to be conforming.Packaging label log lppf, lmd/lpf rev b was reviewed and determined to be conforming.Packaging bom was reviewed and determined to be conforming with no deviations to normal packaging identified.Scn 12298 supplied by (b)(4) was reviewed and determined to be conforming.This lot met all dimensional, visual, sterility and packaging criteria at the time of release with no issues documented during the inspection or release of the product that would contribute to this complaint condition.Component part(s) reviewed: part number: 21014, tialnbri16.00 lot number: 7557656 lot quantity: (b)(4).Certified test report supplied by (b)(4).Dated 22-nov-2013 and inspection certificate supplied to perryman by vsmpo dated 25-jun-2012 were reviewed and determined to be conforming.Lot summary report dated 12-dec-2013 met all inspection acceptance criteria.Raw material receiving/putaway checklist met all inspection acceptance criteria.Device history batch null, device history review 11-jul-2019: dhr reviewed, 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.H3, h6: investigation summary complaint summary: on november 19, 2018, the patient suffered worsening of elbow pain and radiographic evidence of severe osteolysis around the implant.There was also loosening of the radial head prosthesis.On (b)(6) 2018, the patient underwent radial head arthroplasty using a radial head prosthesis on his left elbow.An incision was made over the lateral elbow in line with the previous incisional scar.Dissection of the soft tissues was performed with bovie electrocautery.Sutures in the fascia were identified and removed.The fascia was dissected sharply with tenotomy scissors and the interval between ecrb and edc identified.The joint capsule was incised, and the annular ligament was also incised.The radial head prosthesis was then visualized.The screw connecting the radial head component to the stem was loosened and removed, allowing for staged removal of first the head and then the stem.The wound was then irrigated with 3l normal saline.Powdered vancomycin and tobramycin was placed into the wound.The annular ligament was closed with 2-0 pds suture.The interval between edc and ecrb was closed with 0 vicryl sutures in a simple interrupted fashion.The more superficial layers were closed with 2-0 vicryl sutures in inverted simple interrupted fashion and the skin was closed with 3-0 nylon vertical mattress sutures.The wound was dressed in xeroform, 4 x 4s, an abd, and then wrapped with kerlix and an ace bandage.On (b)(6) 2018, the patient went back to the emergency room because of pain and redness.The wound was tender, swelling and has erythema.The patient was given steroids to help with the swelling and keflex for concern of infection.The patient was discharged and was given instructions to apply ice for thirty (30) minutes, four (4) times a day for three (3) days.Customer quality investigation: device condition: the pictures were reviewed and based on the pictures alone us cq cannot confirm the complaint.However, there are known issues with the radial head implants.Document/specification review: a device history review, was performed for the returned instrument¿s lot number, and no ncrs, no mrrs or complaint-related issues were identified with the lot number which may have contributed to the complaint condition.Conclusion: no definitive root cause was able to be determined as the circumstances surrounding the event are unknown.During the investigation no unidentified product design/manufacturing issues or discrepancies were observed (based on the images) that may have contributed to the complaint condition.However, "relevant actions have been taken to address the issue.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 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.If the information is unknown, not available or does not apply, the section/field of the form is left blank.H10: additional narrative: b5, b6, b7 h11: corrected data: d4, h9 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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On (b)(6) 2016, the patient sustained an injury to the left elbow.He fell from a height landing on the left arm with immediate onset of pain, swelling, and inability to mobilize the left elbow.He was seen at the emergency room.Evaluation was performed and x-rays were obtained documenting evidence for a comminuted displaced proximal radial head fracture.Splinting provided and orthopedic follow-up with the trauma was arranged.He was seen there, repeat x-rays were obtained, and arrangements were made for surgical treatment.On (b)(6) 2018, the patient presented to triage for left upper extremity pain and redness.On physical examination shows left elbow tenderness, swelling and erythema.Patient presented to emergency department for pain and swelling and managed for pain and recommended for follow up.On (b)(6) 2018, radiographs were done, it was noted that there was considerable osteolysis around the implant, which was loose and nonfunctioning.There was resorption of bone and loss of proximal radius bone structure.He was prepared for surgery.Postoperative course was complicated by a superficial infection, which resolved.Follow-up evaluations documented persistent loss of elbow range of motion.He was prescribed a dynamic splint, which uses as prescribed.He stated that initially he regained some elbow range of motion.However, for the past several months he is aware that his elbow movement has not changed.At present, the patient stated that his left elbow pain is a 3 to 4/10, which is constant.He felt most comfortable with the arm at his side and held at a 90-degree flexion position.He has increased pain when holding weight or when there is repetitive twisting movement.He was not comfortable with impact to the hand, which caused pain radiating up into the forearm into the elbow.The pain is principally over the lateral elbow, but also along the proximal posterior aspect of the forearm, and the distal upper arm.He stated that frequently when his arm on a rest within a short period of time he has increased pain.On (b)(6) 2018, the patient presented for follow up visit for evaluation of the left elbow.Imaging studies revealed successful removal of radial head implant and there are no complications.
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