SMITH & NEPHEW, INC. UNKN ORTHOPAEDIC RECONSTRUCTION DEV; PROSTHESIS, HIP, FEMORAL COMPONENT, CEMENTED, METAL
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Catalog Number UNKNOWN |
Device Problem
Naturally Worn (2988)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 02/25/2022 |
Event Type
Injury
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Event Description
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It was reported that, after a surgery performed on (b)(6) 2005, the g-taper head was revised on (b)(6) 2022 due to wear.The surgeon says the devices were not defective.Current health status of the patient is unknown.
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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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The device was not returned for evaluation and the reported event could not be confirmed.The clinical/medical investigation concluded that, a revision of the head due to wear almost 15 years post implantation.Per the complaint details, ¿the surgeon says the devices were not defective.¿ it is noted within the attachments no clinical/medical documentation is available.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.At this time, we have no reason to suspect that the product failed to meet any product specifications at the time of manufacture.Potential causes could include but are not limited to friction, joint tightness or lifetime of device.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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