SMITH & NEPHEW, INC. UNKN FEM HEAD MEMPHIS METAL; PROSTHESIS, HIP, FEMORAL COMPONENT, CEMENTED, METAL
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Catalog Number UNKNOWN |
Device Problem
Biocompatibility (2886)
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Patient Problems
Ossification (1428); Metal Related Pathology (4530)
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Event Date 11/30/2021 |
Event Type
Injury
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Manufacturer Narrative
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Internal complaint reference: (b)(4).
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Event Description
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It was reported that, after an unspecified tha construct had been implanted on the patient¿s left hip on (b)(6) 2014, the patient experienced trunnionosis of the left hip construct along with metallosis and abductor muscle necrosis.A revision surgery on (b)(6) 2021 to treat this adverse event.During this procedure, both abductor muscle necrosis and capsular tissue necrosis involving more than 30% of the abductor muscles were noticed, and the femoral head presented extensive corrosion upon removal from the taper.In addition, significant heterotrophic ossification around the proximal femur and acetabulum was excised.As part of this procedure, the femoral head and acetabular liner were explanted and replaced with a 36mm inner diameter liner associated to a 36mm oxinium femoral head.The patient was transported to the recovery room in stable condition.
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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 determined that, it cannot be concluded what impact the ¿small amount of shuck¿ had on the patient¿s pain and clinical status.The clinical root cause of the heterotopic ossification cannot be confirmed some patients can be genetically predisposed to heterotopic ossification, it is a known complication of joint surgeries and is related to the procedure and not the device.Its also noted that the acetabular shell was not under-reamed and cannot conclude how this could have impacted the reported findings.The reported corrosion at the taper of the head is consistent with trunionosis.As well, with the limited information provided the clinical root cause of the reported pain, elevated metal ions and necrotic tissue cannot be confirmed.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 damaged product, friction, joint tightness, lifetime of device, implant corrosion, wear or patient condition.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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