SMITH & NEPHEW, INC. COCR FEM HD GT 28OD +0; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED
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Model Number 71302800 |
Device Problem
Device Dislodged or Dislocated (2923)
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Patient Problem
Injury (2348)
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Event Date 12/03/2018 |
Event Type
Injury
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Event Description
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It was reported that a revision surgery was performed due to a tandem shell dislocated from the stem without the head coming off the stem.Retaining ring is reported to be stuck in the shell and could not be removed.Stem remained in the patient.
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Manufacturer Narrative
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The associated complaint devices were not returned.A clinical evaluation was conducted and the single right hip x-ray labeled post reduction was reviewed.However, it does not contribute to the investigation nor does it aide in the determining the root cause for the reported dislocation.Without the requested clinical information a thorough medical investigation cannot be rendered.No further clinical/medical assessment is warranted at this time.A review of complaint history on the listed parts revealed no prior complaints for the listed batches with the same failure mode.A review of the manufacturing records did not reveal a manufacturing abnormality that could have caused or contributed to the reported incident.Without the actual product involved and/or device information, our investigation cannot proceed.If the device or new information is received in the future, this complaint can be re-opened.No further actions are being taken at this time.We consider this investigation closed.
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Manufacturer Narrative
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The devices, used in treatment, were returned for evaluation.A lab analysis visually confirmed damage; scratches on the od the bipolar head and id of the head.The poly liner, poly retaining ring, and lock ring showed no damage.A dimensional evaluation of the critical-to-quality features was completed.The tandem shell and cocr head were within print specifications.The cross-linked polyethylene lock ring was oversized, expectedly due to the reporting of the cocr head passing through the ring and the dislocation.Likely caused warping or stretching of the poly; reflected in the measurements.The retaining ring measured oversized for the tab height; potentially as result of the dislocation assembly potentially warped the ring.The failure mode cannot be confirmed as a manufacturing defect.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 have no reason to suspect that the product failed to meet any product specifications at the time of manufacture.A clinical evaluation was conducted and confirms that x-ray was reviewed, however, it does not contribute nor aide in determining the dislocation root cause.A review of complaint history on the listed parts revealed no prior complaints for the listed batches with the same failure mode.A review of the risk management file and instructions for use document revealed this failure mode was previously identified.Factors and/or potential causes that could contribute to the reported event have been identified in the risk management file, as improper device size selection or user/procedural variance.Based on this investigation, the need for corrective action is not indicated.
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