SMITH & NEPHEW, INC. LGN CR HIGH FLEX XLPE SZ 3-4 12MM; PROSTHESIS,KNEE,PATELLOFEMOROTIBIAL,SEMICONSTRAINED,CEMENTED,POLYMERMETALPOLYMER
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Model Number 71453184 |
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 04/26/2022 |
Event Type
malfunction
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Event Description
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It was reported that, during a tka surgery, when the customer opened the lgn cr high flex xlpe sz 3-4 12mm package, it was found that the pouch had damaged.Surgery was resumed, without any delay, with a smith and nephew back-up device.Patient was not harmed.No further complications reported.
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Manufacturer Narrative
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Internal complaint reference: (b)(4).
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Manufacturer Narrative
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Section h3, h6: the associated device was returned and evaluated.A visual inspection of the returned device confirmed the stated failure mode.The device's inner packaging was found to be compromised along the side of the packaging, rendering the device inoperable.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 risk management file revealed this failure mode was previously identified.The anticipated risk level is still adequate.According to the packaging sequence, the pouch should be sealed.Assessment of historical escalated cases concluded that there are no prior actions related to this device and failure mode.A contribution of the devices to the reported event could be corroborated as the packaging of the device show signs of damage.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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