SMITH & NEPHEW, INC. R3 3 HOLE ACET SHELL 50MM; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/CERAMIC/CERAMIC/METAL, CEMENTED OR UNCE
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Model Number 71335550 |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problem
Swelling/ Edema (4577)
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Event Date 02/08/2022 |
Event Type
Injury
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Event Description
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It was reported that, after a thr on (b)(6) 2021, revision surgery was performed on (b)(6) 2022 due to accumulating water.The r3 3 hole acet shell 50mm was explanted.The surgeon says it was not caused by infection.No causative microorganism (bacteria) is detected.Also, the surgeon did not think s+n devices were defective.It is unknown the current health status of the patient.
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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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H3, h6: the device was not returned for evaluation and the reported event could not be confirmed.The clinical/medical investigation concluded that smith and nephew has not received the explanted device and/or adequate materials to fully evaluate the complaint.If additional clinically relevant materials are later received, then the case may be re-opened for further evaluation.A review of the manufacturing records 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 ifu document for the total hip systems provides complete guidelines of indications, contraindications, warnings and precautions and possible adverse effects that may occur preoperative, during surgery or post-operative.There is no sufficient evidence to relate the specific reported event to the device.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 product specifications at the time of manufacture.Some potential probable causes for this event could include but not limited to post operative healing issue or patient reaction.The contribution of the device to the reported event could not be corroborated.Based on this investigation, the need for corrective action is not indicated.Without the return of the actual product involved, our investigation could not proceed.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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