SMITH & NEPHEW, INC. UNKNOWN R3 CERAMIC LINER; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/CERAMIC/CERAMIC/METAL, CEMENTED OR UNCE
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Catalog Number UNKNOWN |
Device Problems
Fracture (1260); Insufficient Information (3190)
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Patient Problems
Failure of Implant (1924); Insufficient Information (4580)
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Event Date 01/16/2023 |
Event Type
Injury
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Event Description
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It was reported that, after a thr revision surgery had been performed approximately two (2) years ago due to a ceramic-on-ceramic bearing fracture, the patient required an additional revision surgery on (b)(6) 2023 due to unknown reasons.During this procedure, a 58mm/36mm r3 ceramic liner was implanted.Additional details related to this procedure are yet to be confirmed.
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Manufacturer Narrative
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Internal complaint reference: case(b)(4).
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Manufacturer Narrative
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H10: additional information received by the manufacturer has been reviewed.The previously provided part number is not accurate, as there could be more than one ceramic liner combination for a 58 mm acetabular r3 shell.Additional information has been requested to the local office & hospital.Any additional findings will be eventually communicated.
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Event Description
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It was reported that, after a thr revision surgery had been performed approximately two (2) years ago due to a ceramic-on-ceramic bearing fracture, the patient required an additional revision surgery on (b)(6) 2023 due to an additional ceramic liner fracture.During this procedure, a 58mm/36mm r3 ceramic liner was implanted.Additional details related to this procedure are yet to be confirmed.
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Manufacturer Narrative
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H3, h6: the device was not returned for evaluation; therefore, a device analysis could not be performed.The clinical/medical investigation concluded that, per complaint details, the patient had a second revision approximately two years after the first revision due to ceramic-on-ceramic liner fracture.As of the date of this medical investigation, the requested clinical documentation has not been provided for evaluation.Therefore, there were no clinical factors found which would have contributed to the reported event.The patient impact beyond that which has already been reported cannot be determined.No further clinical assessment can be rendered at this time.Device specific identifiers were not provided.Therefore, an evaluation of the manufacturing records, complaint history review, instructions for use, risk management file, prior actions and product prints review could not be performed.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 traumatic injury, size selected, surgical technique or postoperative care.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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