| Model Number N/A |
| Device Problems
Break (1069); Mechanical Problem (1384); Dull, Blunt (2407); Material Twisted/Bent (2981); Appropriate Term/Code Not Available (3191)
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| Patient Problems
No Code Available (3191); No Clinical Signs, Symptoms or Conditions (4582)
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| Event Date 11/19/2020 |
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Event Type
malfunction
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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.Medical products: zimmer anatomical shoulder, shaft size 9.5, cementless; catalog#: unknown; lot#: unknown.Humeral head dia50-18; catalog#: 0104212505; lot#: unknown; liners; catalog#: 0104440012; lot#: 2984779; dpsc screw 3.5/4.5x30mm; catalog#: 0104440030; lot#: 2997053; dpsc screw 3.5/4.5x39mm; catalog#: 0104440039; lot#: 2994819; dome centric; catalog#: 0104227005; lot#: unknown.Therapy date: unknown.The manufacturer received 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.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 there was an intraoperative complication.The instrument could not be inserted and was deformed.After utilizing the threaded distractor together with the rotation bolt, the tm sleeve around the central post of the anaverse baseplate broke off, along with the locking cap, so that only the anaverse baseplate was removed.The tm sleeve, and the locking cap had to be extracted separately.Half of the tm sleeve got destroyed.There was a surgical delay of 20-30 minutes.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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Event Description
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The instrument was neither defective nor bent.It just didn't work as expected due to the tm sleeve being ingrown.
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Manufacturer Narrative
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Additional information which was received on dec 11, 2020.The manufacturer received other source documents for review.Should any additional information become available or an investigation result be available, that changes this assessment, an amended medical device report will be submitted.Zimmer¿s reference number of this file is (b)(4).
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Manufacturer Narrative
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Additional information which was received on apr 13, 2021.This follow-up report is being filled to relay additional information, which was unknown at the time of the previous medwatch.Additionals: a1, a2, b5, d8, h2, h6.Corrections: b4, g3, g6, h10.The manufacturer received x-rays and other source documents for review.Should any additional information become available or an investigation result be available, that changes this assessment, an amended medical device report will be submitted.Zimmer¿s reference number of this file is (b)(4).
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Event Description
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The instrument was neither defective nor bent.It just didn't work as expected due to the tm sleeve being ingrown.
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Event Description
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No event update.Investigation results are now available.
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Manufacturer Narrative
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Investigation results were made available.Review of event description: it was reported that during revision surgery of 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 utilizing the threaded distractor together with the rotation bolt, the tm sleeve around the central post of the anaverse baseplate broke off along with the locking cap, so that only the anaverse baseplate was removed.The tm sleeve and the locking cap had to be extracted separately.Half of the tm sleeve got destroyed.There was a surgical delay of approx 20-30 minutes.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.Discussing the failure mode with extremities development, the following was determined: the intention of the convertible system was, that in most situation, the reason for removing a convertible baseplate would be infection, in which case the bone would likely be softened.In that case, the instrumentation is appropriate.However, due to the liner issues, the baseplate is being revised from good and vital bone, and so the forces required to disassemble the baseplates and pegs are much higher than normal.During explantation, there is a chance that the tm sleeve may disassemble from the baseplate/pegs.Medical documents: no surgical report from revision surgery was received.X-rays were received, however, do not contribute to the investigation of this intraoperative complication.Product evaluation: visual examination: the explants and especially the baseplate with it tm sleeve and cap were returned for an investigation.The front side of the anaverse glenoid baseplate is worn except for two areas around the screw holes, whereas the unworn area around the superior hole is larger.The inferior posterior edge is worn in such a way that it is deformed out- and downward forming a new tiny ledge.The two kidney-shaped slots for the instruments are slightly deformed/damaged superiorly posterior and inferiorly anterior respectively.Marks from contact with the screw heads can be seen in both screw holes.In the inferior screw hole signs of bone ongrowth can be observed as well.Further, on the front side scratches as well as larger and smaller spots most probably deriving from the use of an electrocautery tool are recognizable.Single spots can be found as well on the baseplate¿s lateral area.The inferior and the posterior snap-fit features are damaged due to wear and removal.There are no signs of bone ongrowth on the anchoring side of the baseplate.Slight deformation / damage is visible on the edge of the two kidney-shaped slots for the instruments on opposite sides as described for the baseplate¿s front side.The trabecular metal (tm) sleeve and the locking cap were received separated from the central post of the anaverse glenoid baseplate.Arranging the tm sleeve next to the basepate¿s central post it can be observed that both have the same length.The tm sleeve exhibits bone on- / in growth (partially through entire thickness of the material), damage due to removal, is deformed and a piece is missing.On one end the sleeve has a proud rim of approximately 3 mm in length on approximately 3 quarters of the circumference of the sleeve¿s lateral area.In the latter the surface has mainly a shiny appearance.In the remaining quarter bone ongrowth is visible on the entire lateral area which seems to be spared from removal damage.The face surface of the tm sleeve on the side with the rim exhibits bone ongrowth and the material thickness seems to be equal.The face surface on the other end of the sleeve does not show an equal material thickness on its entire circumference.Further, closer inspection of the rim¿s face surface with a low power microscope revealed shiny traces probably deriving from an instrument.The thread of the locking cap is fractured.The upper fracture part of the thread remained in the thread of the central post of the baseplate.Some circumferential scratches are visible on the rear side of the cap.There is some damage probably due to the removal especially along the edge of the cap.Review of product documentation: device purpose: this device is 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.Conclusion: it was reported that during revision surgery of 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 utilizing the threaded distractor together with the rotation bolt, the tm sleeve around the central post of the anaverse baseplate broke off along with the locking cap, so that only the anaverse baseplate was removed.The tm sleeve and the locking cap had to be extracted separately.Half of the tm sleeve got destroyed.There was a surgical delay of approximately 20-30 minutes.Based on the investigation the reported event can be confirmed.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 non-conformance or a complaint out of box (coob).Considering the time in vivo and the young age of the patient as well as that the tm sleeve shows bone on- /ingrowth it is assumed, that the post of the baseplate was firmly fixed in the bone at revision surgery.As slight deformation/damage was seen in the slots of the baseplate it seems that the fixation release had been used.According to the information at hand the instrument did not function and the tm sleeve and the locking cap remained in situ while the baseplate could be removed.Therefore, it is supposed that the fracture of the thread of the locking cap occurred during removal.It seems that a thin portion of tm material had been cut off on about three quarters of the lateral area of the sleeve.It remains unknown if this derived from the use of the fixation release and/or during the additional procedure to remove the tm sleeve and the locking cap.The surgical report of revision surgery and/or intraoperative photos (showing the operative field) that could give insight to the performed removal steps were not received for evaluation.Based on the given information and the results of the investigation, we were not able to identify a specific root cause for this issue.Note: the anaverse implants (or similar devices) are not released in us, therefore only the instrument (fixation release tm post, similar devices cleared or distributed in the united states) was subjected to reporting in the present medwatch.This instrument has not been received for investigation.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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