Model Number N/A |
Device Problems
Manufacturing, Packaging or Shipping Problem (2975); Appropriate Term/Code Not Available (3191)
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Patient Problems
Perforation (2001); Device Embedded In Tissue or Plaque (3165); Insufficient Information (4580)
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Event Date 11/10/2020 |
Event Type
Injury
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Manufacturer Narrative
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Concomitant medical product: liner, s; item# 0104440012; lot# 2986237.Dpsc screw, 21mm; item# 0104440021; lot# 3010148.Dpsc screw, 18mm; item# 0104440018; lot# 2994813.Sidus stem-free shoulder, humeral anchor, uncemented, m; item# 0104555120; lot# unknown.Sidus stem-free shoulder, humeral head, 44-16; item# 0104555440; lot# unknown.The manufacturer received x-rays and other source documents for review.The manufacturer did not receive the device for investigation.As no lot number was provided, the device history records could not be reviewed.Additional information has been requested and is currently not available.A cause for this specific event cannot be ascertained from the information provided.As soon as supplemental information becomes available an updated report will be submitted.(b)(4).
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Event Description
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During revision surgery the surgeon couldn't release the bone around the central post of the anaverse baseplate using the fixation release tm post (instrument).After using the special extraction instrument, the baseplate could be removed.However, the tm sleeve was left in the bone and this had to be extracted with effort.
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Manufacturer Narrative
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This product is manufactured by zimmer biomet winterthur and is not cleared or distributed in the u.S.However, this report is being submitted as zimmer biomet winterthur manufactures a similar device that is cleared or distributed in the united states.As per fda¿s directive, medwatch report has been resubmitted.Dec 02, 2020(fda communicated date) has been considered as supplemental date of dt but in the medwatch report g4(date received by manufacturer) considered as per 0009613350-2020-00562 as the report was submitted on time.D11- medical product: liner, s; item# 0104440012; lot# 2986237.Dpsc screw, 21mm; item# 0104440021; lot# 3010148.Dpsc screw, 18mm; item# 0104440018; lot# 2994813.Sidus stem-free shoulder, humeral anchor, uncemented, m; item# 0104555120; lot# unknown.Sidus stem-free shoulder, humeral head, 44-16; item# 0104555440; lot# unknown.The manufacturer received x-rays and other source documents for review.The manufacturer did not receive the device for investigation.As no lot number was provided, the device history records could not be reviewed.Additional information has been requested and is currently not available.A cause for this specific event cannot be ascertained from the information provided.As soon as supplemental information becomes available an updated report will be submitted.Zimmer biomet¿s reference number of this file is (b)(4).
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Event Description
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During revision surgery the surgeon couldn't release the bone around the central post of the anaverse baseplate using the fixation release tm post (instrument).After using the special extraction instrument, the baseplate could be removed.However, the tm sleeve was left in the bone and this had to be extracted with effort.Note: the implantation and explantation dates are left empty as the device involved in this complaint is an instrument.Hence, no expiration date is captured, for the same reason.
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Manufacturer Narrative
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This follow-up report is being submitted to relay corrected and additional information.Additional: h2, h6.Correction: b4, g3, g6, h10.Event description: it was reported that during revision surgery on anaverse anatomical implants on the (b)(6) 2020 there was an intraoperative complication, whereby the surgeon couldn't release the bone around the central post of the anaverse baseplate using the fixation release tm post (instrument).After using the special extraction instrument, the baseplate could be carefully removed.However, the tm sleeve was left in the bone and had to be extracted with effort using a curved chisel and forceps.The resulting bone loss is filled with cancellous bone graft.Review of received data: due diligence: no further due diligence required as all required information to support the conclusion is available or was already requested.X-rays: x-rays for the time prior to revision surgery have been received however, are found to be not relevant for this intraoperative issue.Surgical report: surgical report from revision surgery, dated (b)(6) 2020 was received and reviewed: the baseplate was found to be well fixed.However, the screws can be removed without any problems.Usage of special chisel in order to loosen the bone.This does not success completely, so that the metal plate has to be removed with care.Using the special extraction instruments, the baseplate can be removed with care.The problem is, that the tm post remains in the bone.Round chisel is used to carefully remove the post.Trying to remove with forceps, post fractures in smaller pieces.Removal of pieces.Based on the review the intraoperative complaint can be confirmed.E-mail from the surgeon dr.Jörg neumann to markus rauscher (zb) dated (b)(6) 2020: jörg neumann (email: di.17.11.2020 11:16): die basisplatte war fest.Die tm hülse und die grüne mutter sind zunächst im glenoid verblieben und mussten mühsam herausgelöst werden.Dieser komische zweizackige meisel zum lockern des knochens vom stem ist totaler mist und unbrauchbar, da sich die zarten klingen sofort verbiegen, hatte ich schon in tübingen angemahnt.Grund der revision: liner dislokation und wunsch des patienten bei tsa zu verbleiben und keine reversetsa einzusetzen.Product evaluation: the fixation release tm post instrument was not returned for investigation; therefore, visual and dimensional evaluation could not be performed the baseplate was returned for investigation and analysed.Review of product documentation: device purpose: this devices are intended for treatment.Product compatibility: the product combination was approved by zimmer biomet.Dhr review: the quality records of the baseplate show that all specified characteristics have met the specifications valid at the time of production.The quality records of the fixation release tm post instrument can not be reviewed due to missing lot number.Conclusion: it was reported that during revision surgery on anaverse anatomical implants on the (b)(6) 2020 there was an intraoperative complication, whereby the surgeon couldn't release the bone around the central post of the anaverse baseplate using the fixation release tm post (instrument).After using the special extraction instrument, the baseplate could be carefully removed.However, the tm sleeve was left in the bone and had to be extracted with effort using a curved chisel and forceps.The resulting bone loss is filled with cancellous bone graft.Based on the investigation the reported event can be confirmed.As per composed e-mail by the surgeon, the reason for the non-functioning of the instrument is due to its blades being frail and bending upon utilization.The instrument was however not returned for investigation.Additionally, the quality records of the fixation release tm post instrument could not be reviewed due to the missing lot number.The quality records of the baseplate show that all specified characteristics have met the specifications valid at the time of production.Therefore, the investigation did not identify a nonconformance or a complaint out of box (coob).Based on the given information and the results of the investigation, we were not able to identify a specific root cause for this issue.The need for corrective measures is not indicated and zimmer switzerland manufacturing gmbh considers this case as closed.Zimmer biomet¿s reference number of this file is (b)(4).
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Event Description
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No change to previously reported event.
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Search Alerts/Recalls
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