SMITH & NEPHEW, INC. R3 US DELTA HEAD 32 +4; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/CERAMIC/CERAMIC/METAL, CEMENTED OR UNCE
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Model Number 71325172 |
Device Problem
Improper or Incorrect Procedure or Method (2017)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 04/19/2022 |
Event Type
Injury
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Event Description
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It was reported that after a thr, it was noticed that the r3 us delta head 32 +4 was implanted with a 36 liner, which is a size mismatch.Patient is scheduled for revision surgery.
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Manufacturer Narrative
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H10: internal complaint reference: case (b)(4).
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Manufacturer Narrative
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Given the nature of the alleged incident, the device could not be returned for evaluation; therefore, a device analysis could not be performed.The clinical/medical investigation concluded that the requested clinical documentation had not been provided.It was reported that the surgeon noticed after a total hip replacement that the r3 us delta head 32 +4 was implanted with a 36 liner, which is a size mismatch.Therefore, there were no clinical factors found which would have contributed to the event.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 instructions for use documents for total hip systems revealed that the appropriate type and size should be selected for patients with consideration of anatomical and biomechanical factors.This has been identified in warnings and precautions.A review of the risk management file revealed this failure mode was previously identified.The anticipated risk level is still adequate.A historical review concluded that there are no prior actions related to this product and event.At this time, we have no reason to suspect that the product failed to meet any specifications at the time of manufacture.Factors that could contribute to the reported event include size selected, surgical technique used or user/procedural variance.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 for future complaints and investigate as necessary.We consider this investigation closed.
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