Model Number 6191-1-001 |
Device Problem
Insufficient Information (3190)
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Patient Problem
Pain (1994)
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Event Date 10/01/2018 |
Event Type
Injury
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Manufacturer Narrative
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It was noted that the device is not available for evaluation.If additional information is received, it will be provided in a supplemental report upon completion of the investigation.
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Event Description
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Patient stated he had a left tka done on (b)(6) 2018, he was implanted with stryker cement and competitor implants.Patient had physical therapy after surgery.On (b)(6) 2018 patient started to experience excruciating pain walking up and down the stairs.On (b)(6) 2019 he saw dr.(b)(6) and was recommend a bone scan, based on the results he was told he needed to be revised as the cement used was debonded and breaking up.Patient reached out to his primary surgeon and was revised.Patient had physical therapy.In mid (b)(6) 2019 patient started to experience excruciating pain.He went for an x-ray and a couple of days later he had an mri and was told he had a fractured knee cap due to the cement breaking up and debonding.Two months ago patient stated he was walking down the stairs when felt a pop, could not lift his left heel up and experienced excruciating pain.He had an emergency mri and met with his surgeon and was told he had scar tissue that had developed.Patient is still experiencing excruciating pain.Patient is seeking compensation.This pi is for revision of the primary.
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Manufacturer Narrative
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Reported event: an event regarding loosening and periprosthetic fracture involving a simplex cement mix was reported.Method & results: device evaluation and results: not performed as the associated device is oem product.Clinician review: not performed as the associated device is oem product.Device history review: not performed as the associated device is oem product.Complaint history review: not performed as the associated device is oem product.Conclusions: the reported device is an oem product.Written acknowledgement from the oem supplier that an investigation has been initiated at the oem supplier site was received, and has been attached within the communication log.H3 other text : device not returned.
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Event Description
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Patient stated he had a left tka done on (b)(6) 2018, he was implanted with stryker cement and competitor implants.Patient had physical therapy after surgery.On (b)(6) 2018 patient started to experience excruciating pain walking up and down the stairs.On (b)(6) 2019 he saw dr.(b)(6) and was recommend a bone scan, based on the results he was told he needed to be revised as the cement used was debonded and breaking up.Patient reached out to his primary surgeon and was revised.Patient had physical therapy.In (b)(6) 2019 patient started to experience excruciating pain.He went for an x-ray and a couple of days later he had an mri and was told he had a fractured knee cap due to the cement breaking up and debonding.Two months ago patient stated he was walking down the stairs when felt a pop, could not lift his left heel up and experienced excruciating pain.He had an emergency mri and met with his surgeon and was told he had scar tissue that had developed.Patient is still experiencing excruciating pain.Patient is seeking compensation.This pi is for revision of the primary.
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Search Alerts/Recalls
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