SMITH & NEPHEW, INC. R3 0 DEG XLPE ACET LNR 32MM X 50MM; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, CEMENTED
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Model Number 71339550 |
Device Problems
Delivered as Unsterile Product (1421); Unsealed Device Packaging (1444)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 04/19/2022 |
Event Type
malfunction
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Event Description
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It was reported that, the first layer of an r3 0 deg xlpe acet lnr 32mm x 50mm package was received opened.As this was noticed upon set-up or inspection for thr surgery, the patient was not involved at that moment.
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Manufacturer Narrative
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(b)(4).
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Manufacturer Narrative
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H3, h6: the device was not returned for evaluation but the pictures were reviewed, and revealed that seal integrity has been compromised.A review of the production order did not reveal a manufacturing abnormality that could have caused or contributed to the reported incident.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 risk management file revealed this failure mode was previously identified.The anticipated risk level is still adequate.A review of the sterilization records revealed the batch was sterilized within normal parameters.A historical review concluded that there are no prior actions related to this product and event.No other parts were affected by this particular incident.A risk assessment was conducted and the risk is within the anticipated range.At this time, we have no reason to suspect that the product failed to meet any product specifications at the time of manufacture.Factors that could contribute to the reported event include damage during shipping, mishandling or manufacturing process error.The contribution of the device to the reported event could be corroborated as it wasn't used in the procedure because of the damaged package.Based on this investigation, the need for corrective action is not indicated.Should the device or additional information be received, the complaint will be reopened.No further investigation is warranted for this complaint; however, we will continue to monitor for future complaints and investigate as necessary.We consider this investigation closed.
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