It was reported that during the surgery, when trying to separate the proximal neck from the distal shaft using a dismantling instrument, the threaded rod was seized and could no longer be turned or unscrewed.The entire stem including the instruments had to be removed and a new stem was implanted.
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This product is manufactured by zimmer biomet (b)(4) and is not cleared or distributed in the u.S.However, this report is being submitted as zimmer biomet (b)(4) manufactures a similar device that is cleared or distributed in the united states.Associated devices: revitan, disassembly instrument; catalog#: 01.00409.801; lot#: 05.161079.Revitan, disassembly sleeve; catalog#: 01.00409.816; lot#: unknown.Revitan distal part, curved, uncemented, 18/140; catalog#: 01.00406.118; lot#: 3016562.Revitan proximal part, cylindrical, uncemented, 105, taper 12/14; catalog#: 01.00402.105; lot#: 3054979.Review of event description: it was reported that during the surgery on (b)(6) 2021, when trying to separate the proximal neck from the distal shaft using a dismantling instrument, the threaded rod was seized and could no longer be turned or unscrewed.The entire stem including the instruments had to be removed and a new stem was implanted.Review of received data: x-rays: the provided x-rays were reviewed but not sent for further analysis as the revision op notes were provided and have sufficient information.Surgical report: review of the provided surgical report identified the instruments and implant became stuck together during the attempt to remove the distal component from the proximal component.The surgeon then removes both the distal and proximal component together.It was reported that the customer followed the surgical technique.Product evaluation: visual examination: the visual examination confirms the reported event; it shows that the disassembly sleeve, disassembly instrument, threaded rod, and distal implant are all connected together.The devices could not be disassembled from one another using hand force.Review of product documentation: device purpose: all involved devices are intended for treatment.Product compatibility: the product combination was approved by zimmer biomet.Instruction for use (ifu): review of the ifu identified that the disassembly instrument and threaded rod can seize if the proper maintenance is not completed, which includes treated the threads of the instruments with lubricants.Surgical technique: review of the surgical technique identified that the threads of the threaded rod and disassembly instrument need to be treated with a lubricant after each cleaning.Conclusion: it was reported that during the surgery on (b)(6) 2021, when trying to separate the proximal neck from the distal shaft using a dismantling instrument, the threaded rod was seized and could no longer be turned or unscrewed.The entire stem including the instruments had to be removed and a new stem was implanted.Based on the investigation the reported event can be confirmed.The quality records 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).It was noted that previously the surgical technique was updated for the curved and straight revitan stems to include more clear information regarding the necessity of lubricating the threaded rod and disassembly instrument after the devices are cleaned.This information is also communicated in the ifu and that lack of lubrication can lead to the threaded rod and disassembly instrument seizing.However, it was noted that the surgeon followed the surgical technique.As such, we are not able to identify a specific root cause for this issue.The need for corrective measures is not indicated and zimmer(b)(4) considers this case as closed.Zimmer biomet's reference number of this file is (b)(4).
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