SMITH & NEPHEW, INC. OXINIUM FEM HD 12/14 28MM +0; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/CERAMIC/POLYMER, CEMENTED OR NON-POROUS
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Model Number 71342800 |
Device Problems
Tear, Rip or Hole in Device Packaging (2385); Device Markings/Labelling Problem (2911)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 08/17/2021 |
Event Type
malfunction
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Event Description
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It was reported that four (4) oxinium femoral heads 12/14 taper 28mm had manufacturing labels that were cut off and did not fully display the part number, lot number, quantity and expiration date.As this was noticed in a non-surgical environment, there was no patient involvement.
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Manufacturer Narrative
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H3, h6: the associated device was returned and evaluated.The manufacturing process of the device contributed to the reported event.A visual inspection of the returned device confirmed the stated failure mode.The label on the package was cut off and did not fully display the context of the label.A review of complaint history revealed similar events for the listed batch, this failure mode will be monitored for future complaints for any necessary corrective actions.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 have reason to suspect that the product failed to meet any product specifications at the time of manufacture.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 potential probable cause could but not limited to a misalignment during printing.Based on this investigation, the need for corrective action is not indicated.This event was determined to be low risk.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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Event Description
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It was reported that a oxinium femoral head 12/14 taper 28mm had manufacturing label that was cut off and did not fully display the part number, lot number, quantity and expiration date.As this was noticed in a non-surgical environment, there was no patient involvement.
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Search Alerts/Recalls
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