Model Number 9653-28-043 |
Device Problem
Loss of or Failure to Bond (1068)
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Patient Problem
Insufficient Information (4580)
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Event Date 03/31/2021 |
Event Type
Injury
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Manufacturer Narrative
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(b)(4).If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.
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Event Description
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It was reported that on (b)(6) 2015, the primary surgery was performed via tha for right side with the stem, cup, head and sleeve in question.Competitor plate was also used in the primary surgery.In 2021, when the patient visited the hospital regularly, the cup and plate was loosened.The stem was not loosened.On (b)(6) 2021, the revision surgery was performed.In the revision, after the head was removed, the surgeon tried to remove the stem, but the stem couldn¿t be removed, and it was left in the patient.The competitor implants were set, and the surgery was completed within 30minutes delay.The surgeon commented that the cold welding occurred between the stem and sleeve and the working space was narrow, and he gave up using the schneider cage due to this reason.No further information is available.
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Manufacturer Narrative
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Product complaint #: (b)(4).Investigation summary: no device associated with this report was received for examination.A worldwide complaint database search found no other related reported incidents against the provided product code/lot number combination since release for distribution.Based on previous investigations, this complication of joint replacement is unlikely to have been the result of a device failing to meet required specifications.The information received will be retained for potential series investigations if triggered by trend analysis, post market surveillance, or other events within the quality system.Device history lot : the product investigation found no evidence suspecting an error in the manufacturing or material that would be a contributing factor in the reported allegation(s).Where the lot code was provided, a manufacturing records evaluation (mre) was not performed.
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Event Description
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It was decided that all the implants would be removed in the revision surgery due to infection on (b)(6) 2021.
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Manufacturer Narrative
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Product complaint # (b)(4).Investigation summary : no device associated with this report was received for examination.A worldwide complaint database search found no other related reported incidents against the provided product code/lot number combination since release for distribution.Based on previous investigations, this complication of joint replacement is unlikely to have been the result of a device failing to meet required specifications.The information received will be retained for potential series investigations if triggered by trend analysis, post market surveillance, or other events within the quality system.Device history lot : the product investigation found no evidence suspecting an error in the manufacturing or material that would be a contributing factor in the reported allegation(s).Where the lot code was provided, a manufacturing records evaluation (mre) was not performed.
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Search Alerts/Recalls
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