SMITH & NEPHEW, INC. LGN XLPE PS INSERT SZ 3-4 15MM; PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL
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Model Number 71453249 |
Device Problem
Delivered as Unsterile Product (1421)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 06/16/2022 |
Event Type
malfunction
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Event Description
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It was reported that, during set up for a tka surgery, when opening a lgn xlpe ps insert sz 3-4 15mm, it was found that it was already open.The procedure was finished with a smith and nephew back up device without surgical delay.No further complications were reported.
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Manufacturer Narrative
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(b)(4).
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Manufacturer Narrative
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H10: h3, h6: the associated device was returned and evaluated.A visual inspection of the returned device confirmed the stated failure mode.The device's packaging was found to be compromised along the seal, rendering the device inoperative.A review of complaint history for the part number over the past 12 months and for the batch number based on historical data of the device did not reveal similar events for the listed device.A review of the manufacturing records did not reveal a manufacturing abnormality that could have caused or contributed to the reported incident.At this time, we do not have reason to suspect that the product failed to meet any product specifications at the time of manufacture.A review of the sterilization records revealed the batch was sterilized within normal parameters.A review of the risk management file revealed this failure mode was previously identified.The anticipated risk level is still adequate.Assessment of historical escalated cases concluded that there are no prior actions related to this device and failure mode.A contribution of the device to the reported event could be corroborated as the device's packaging was found to be unsealed.Some potential probable causes for this event could include packaging damage in transit or storage.Based on this investigation, the need for corrective action is not indicated.Should additional information be received, the complaint will be reopened.No further investigation is warranted for this complaint; however, we will continue to monitor future complaints and investigate as necessary.We consider this investigation closed.
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