STANMORE IMPLANTS WORLDWIDE PATIENT SPECIFIC, PROXIMAL TIBIAL REPLACEMENT, TIBIAL COMPONENT; PROSTHESIS, KNEE, FEMOROTIBIAL, CONSTRAINED, CEMENTED, METAL/POLYMER
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Catalog Number UNK_STM |
Device Problem
Packaging Problem (3007)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 03/16/2022 |
Event Type
malfunction
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Manufacturer Narrative
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The reported device is similar to a device approved for compassionate use in the united states.It was noted that the device is not available for evaluation.Should additional information become available, it will be provided in a supplemental report upon completion of the investigation.
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Event Description
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Stryker rep reported there were holes in the packaging of custom made components: "there was a packaging issue with pin 22902, operation date 16th march.There was a hole in the outer packaging of the rotating component that was noticed before the surgery.Started.This didn't compromise the operation as they had a mets component on the shelf.There was also a hole in both outer and inner wrapping of the custom proximal tibia component.This wasn't noticed until the implant was opened.The surgeon spoke to colleagues and followed advice to clean the custom tibia and implant into the patient.".
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Event Description
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Stryker rep reported there were holes in the packaging of custom made components: "there was a packaging issue with pin22902, operation date 16th march.1.There was a hole in the outer packaging of the rotating component that was noticed before the surgery started.This didn't compromise the operation as they had a mets component on the shelf.2.There was also a hole in both outer and inner wrapping of the custom proximal tibia component.This wasn't noticed until the implant was opened.The surgeon spoke to colleagues and followed advice to clean the custom tibia and implant into the patient.".
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Manufacturer Narrative
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Reported event: an event regarding packaging issue involving a patient specific, proximal tibial replacement, tibial component was reported.The event was not confirmed.Method & results: device evaluation and results: not performed as product was not returned clinician review: no medical records were received for review with a clinical consultant device history review: review of the product history records indicate the device was manufactured and accepted into final stock with no reported discrepancies.Complaint history review: there have been no other events for the lot.A discussion between the complaints, operations quality packaging team, and sales rep was held.The sales rep reported the following " [.] - the damage to the proximal tibia packaging was noticed later on when preparing the device for insertion, this device was re-sterilized and inserted [.] - the proximal tibia packaging was thrown away [.] - review of the inspection records show device was checked prior irradiation & dispatch [.] " a review of the ifu noted the following in the section titled "warnings and precautions" it states "[.] if the packaging of parts marked sterile has been compromised or is damaged, do not use [.]" the exact cause of the event could not be determined because insufficient information was provided.Additional information including operative reports, progress notes, and return of the device are needed to fully investigate the event.If further information becomes available or the product is returned, this investigation will be re-opened.
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