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WRIGHTS LANE SYNTHES USA PRODUCTS LLC 22MM COCR RADIAL HEAD STANDARD HEIGHT/12.5MM-STERILE; PROSTHESIS, ELBOW, HEMI-RADIAL , POLYMER
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| Catalog Number 09.402.022S |
| Device Problem
Loosening of Implant Not Related to Bone-Ingrowth (4002)
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| Patient Problems
Pain (1994); 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.Occupation: attorney (b)(4): the reported event required medical/surgical intervention to preclude permanent damage to a body structure for pain, osteolysis, surgical intervention and medical device removal.The investigation could not be completed; no conclusion could be drawn, as no product was received.Investigation summary product was not returned.Based on the information available, it has been determined that no corrective and 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 history: manufacturing location: supplier - (b)(4) / inspected, packaged and released by: (b)(4).Release to warehouse date: 12-feb-2016.Expiration date: 31-jan-2021.Part number: 09.402.022s, 22mm cocr radial head standard height/12.5mm ¿ sterile.Lot number: h032034 (sterile) repackaged from lot number: 9879600.Lot quantity: (b)(4).Work order traveler met all inspection acceptance criteria.Certificate of compliance received from alalign dated 19-jan-2016 was reviewed and determined to be conforming.Inspection sheet, incoming final inspection, met all inspection acceptance criteria.Packaging label was reviewed and determined to be conforming.Packaging bom was reviewed and found to be conforming with no deviations to normal packaging identified.Supplied by (b)(4) was reviewed and determined to be conforming.This lot met all dimensional, visual 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: 21022, tialnbri8.00.Lot number: 5317556.Lot quantity: (b)(4).Product traveler met all inspection acceptance criteria.Raw material inspection sheet, met all inspection acceptance criteria.Product certification supplied by (b)(4) dated 27-sep-2006 was reviewed and determined to be conforming.Raw material receiving/putaway checklist met all inspection acceptance criteria.Part number: 41060, cocrmori25.40.Lot number: 9804004.Lot quantity: (b)(4).Certificate of tests supplied by (b)(4) dated 15-apr-2015 was reviewed and determined to be conforming.Lot summary report dated 30-apr-2015 met all inspection acceptance criteria.Raw material receiving/putaway checklist met all inspection acceptance criteria.Device history batch null, device history review review of the device history record(s) showed that there were no issues during the manufacture of this product, which would contribute to this complaint condition.Device history review 11-feb-2019: 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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Event Description
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It was reported that on (b)(6) 2017, a patient underwent a revision of radial head arthroplasty of the right elbow due to loosening and proximal migration of the prosthesis with significant wallowing out of the proximal radius which caused the patient to feel worsening pain in the elbow.The radial head arthroplasty was able to visualize easily and there was obvious loosening and bone resorption of the prosthesis at the proximal radius.The radial head implant was then removed.The trial size ten (10) stem with a 22mm head was then impacted.The elbow was reduced.C-arm fluoroscopy confirmed satisfactory position of the implant and satisfactory height and size of the radial head.The trial implant was removed.The elbow was irrigated with saline and the definitive implant was then impacted.The elbow was again reduced, and c-arm fluoroscopy confirmed satisfactory position of the implant.On (b)(6) 2016, the patient underwent radial head arthroplasty due to terrible triad injury to the right elbow and was implanted with a 22mm radial head and 9mm radial stem.The joint was opened, and the radial head was completely turned backwards with the articular surface facing distally.The radial head was removed en bloc.Dissection was carried down and the proximal aspect of the radial shaft was then identified.The sagittal saw was then used to resect the remainder of the radial head in line with the radial neck.The elbow was dislocated and the posterior aspect of the joint was evaluated and the bony fragment was able to be easily identified and removed.The elbow was then reduced.Next, the coronoid fragment was identified.It was a fairly small chip fracture significantly too small to allow for screw fixation or open reduction and internal fixation (orif).The fragment was retained in case suture fixation was needed to retain stability and the radial neck was exposed.The radial shaft was then delivered into the wound.Opening all of these opened the proximal aspect of the radius, and then the broachers were used up to a size nine (9) broach.The radial head was resected and measure 24mm.The 24mm with 0 neck and a 9mm shaft radial head were then constructed and placed in position.The elbow was reduced.Then, a double-loaded q-fix all-suture anchor was then placed at the origin of the lateral collateral ligament.The elbow was taken through a range of motion and was completely stable with the lateral collateral ligament repair.Repair of the coronoid fragment was not made and the sutures were then taken out of the lateral collateral ligament and the trial radial head implant was again exposed.The definitive radial head implant was the impacted in position.The elbow was again reduced and the lateral collateral ligament and extensor origin were then repaired using the sutures from the previously-placed anchor.Concomitant device reported: non-synthes device: q-fix all-suture anchor (part# 25-2800, lot# 1138435, quantity 1).This complaint involves two (2) devices.This report is 1 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.Additional information provided.Visual inspection: actual device was not returned.Visual inspection performed at customer quality (cq) of the provided x-ray image was not able to confirm the reported condition.The x-ray image in the facsimile file is of poor quality and does not show visual evidence of the reported condition.The received x-ray condition does not agree with the complaint description.The complaint is not confirmed.Device history record (dhr) review: product traveler met all inspection acceptance criteria.Raw material inspection sheet met all inspection acceptance criteria.Product certification supplied by dynamet was reviewed and determined to be conforming.Raw material receiving/putaway checklist met all inspection acceptance criteria.Investigation conclusion: a definitive assignable root cause for the reported condition could not be determined based on the provided information.This complaint was not able to be confirmed and no manufacturing discrepancies that would contribute to the reported complaint condition were identified during this investigation.The radial head prosthesis system (rhp system) was recalled relevant actions have been taken to address the issue.No new, unique or different patient harms were identified as a result of this evaluation.Additional monitoring for any potential safety signals will be conducted through complaint trending and other post market safety surveillance activities.Based on the investigation findings, it has been determined that no further corrective and/or preventative action is proposed.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.Pma/510k: awareness date reported on follow up 2 report as march 20, 2019 but should have been november 13, 2019.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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Product complaint # (b)(4).H3, h6: investigation summary product was not returned.Based on the information available, it has been determined that no corrective and 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.Updated 22 march 2019 for investigation of provided x-ray image.(actual device was not returned).Background: it was reported that on (b)(6) 2017, a patient underwent a revision of radial head arthroplasty of the right elbow due to loosening and proximal migration of the prosthesis with significant wallowing out of the proximal radius which caused the patient to feel worsening pain in the elbow.The radial head arthroplasty was able to visualize easily and there was obvious loosening and bone resorption of the prosthesis at the proximal radius.The radial head implant was then removed.The trial size ten (10) stem with a 22mm head was then impacted.The elbow was reduced.C-arm fluoroscopy confirmed satisfactory position of the implant and satisfactory height and size of the radial head.The trial implant was removed.The elbow was irrigated with saline and the definitive implant was then impacted.The elbow was again reduced, and c-arm fluoroscopy confirmed satisfactory position of the implant.On (b)(6) 2016, the patient underwent radial head arthroplasty due to terrible triad injury to the right elbow and was implanted with a 22mm radial head and 9mm radial stem.The joint was opened, and the radial head was completely turned backwards with the articular surface facing distally.The radial head was removed en bloc.Dissection was carried down and the proximal aspect of the radial shaft was then identified.The sagittal saw was then used to resect the remainder of the radial head in line with the radial neck.The elbow was dislocated and the posterior aspect of the joint was evaluated and the bony fragment was able to be easily identified and removed.The elbow was then reduced.Next, the coronoid fragment was identified.It was a fairly small chip fracture significantly too small to allow for screw fixation or open reduction and internal fixation (orif).The fragment was retained in case suture fixation was needed to retain stability and the radial neck was exposed.The radial shaft was then delivered into the wound.Opening all of these opened the proximal aspect of the radius, and then the brochures were used up to a size nine (9) broach.The radial head was resected and measure 24mm.The 24mm with 0 neck and a 9mm shaft radial head were then constructed and placed in position.The elbow was reduced.Then, a double-loaded q-fix all-suture anchor was then placed at the origin of the lateral collateral ligament.The elbow was taken through a range of motion and was completely stable with the lateral collateral ligament repair.Repair of the coronoid fragment was not made and the sutures were then taken out of the lateral collateral ligament and the trial radial head implant was again exposed.The definitive radial head implant was the impacted in position.The elbow was again reduced and the lateral collateral ligament and extensor origin were then repaired using the sutures from the previously-placed anchor.Customer quality investigation: h3, h4, h6: 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: 12-feb-2016.Expiration date: 31-jan-2021.Part number: 09.402.022s, 22mm cocr radial head standard height/12.5mm ¿ sterile.Lot number: h032034 (sterile) repackaged from lot number: 9879600.Lot quantity: 24.Component part(s) reviewed: part number: 21022, tialnbri8.00.Lot number: 5317556.Lot quantity: 956 lbs.Product traveler met all inspection acceptance criteria.Raw material inspection sheet, rmtialnbri8_00 rev j met all inspection acceptance criteria.Product certification supplied by dynamet dated (b)(6) 2006 was reviewed and determined to be conforming.Raw material receiving/putaway checklist met all inspection acceptance criteria.Part number: 41060, cocrmori25.40.Lot number: 9804004.Lot quantity: 475 lbs.Certificate of tests supplied by carpenter dated (b)(6) 2015 was reviewed and determined to be conforming.Lot summary report dated (b)(6) 2015 met all inspection acceptance criteria.Raw material receiving/putaway checklist met all inspection acceptance criteria.,null.Device history batch null,null, device history review 11-feb-2019: dhr , 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.,null.Visual inspection: actual device was not returned.Visual inspection performed at customer quality (cq) of the provided x-ray image in complaint file attachment titled "(b)(4) additional information from litigation paralegal (b)(6) 2019" was not able to confirm the reported condition.The x-ray image in the facsimile file is of poor quality and does not show visual evidence of the reported condition.No received x-ray condition agree with the complaint description.The complaint was not confirmed.Dhr review: product traveler met all inspection acceptance criteria.Raw material inspection sheet, rmtialnbri8_00 rev j met all inspection acceptance criteria.Product certification supplied by dynamet dated 27-sep-2006 was reviewed and determined to be conforming.Raw material receiving/putaway checklist met all inspection acceptance criteria.Investigation conclusion: a definitive assignable root cause for the reported condition could not be determined based on the provided information.This complaint was not able to be confirmed and no manufacturing discrepancies that would contribute to the reported complaint condition were identified during this investigation.The radial head prosthesis system (rhp system) was recalled.Any related investigations and assessment of the risks associated with this system will be covered under the recall and investigations.No new, unique or different patient harms were identified as a result of this evaluation.Additional monitoring for any potential safety signals will be conducted through complaint trending and other post market safety surveillance activities.Based on the investigation findings, it has been determined that no further corrective and/or preventative action is proposed.,the complained pictures were forwarded to the medical safety officer for evaluation.Here the statement.The complaint can be confirmed based on the radiographs.The radiographs show: original terrible triad injury/posterior elbow dislocation as described advancing stem radiolucency over the 8 months following implantation.Clinically this would correlate with the intraoperative description of loosening of the synthes rhp.Advancing humeroulnar joint post traumatic osteoarthritis revision implant in place, non-synthes.Product was not returned.Based on the information available, it has been determined that no corrective and preventive 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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