MAUDE Adverse Event Report: SMITH & NEPHEW, INC. UNKN FEM HEAD MEMPHIS METAL; PROSTHESIS, HIP, FEMORAL COMPONENT, CEMENTED, METAL

Catalog Number UNKNOWN

Device Problem Biocompatibility (2886)

Patient Problems Ossification (1428); Metal Related Pathology (4530)

Event Date 11/30/2021

Event Type  Injury  

Manufacturer Narrative

Internal complaint reference: (b)(4).

Event Description

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.

Manufacturer Narrative

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.

• Brand Name: UNKN FEM HEAD MEMPHIS METAL
• Type of Device: PROSTHESIS, HIP, FEMORAL COMPONENT, CEMENTED, METAL
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks rd.; memphis TN 38116
• Manufacturer (Section G): SMITH & NEPHEW, INC.; 1450 brooks rd.; memphis TN 38116
• Manufacturer Contact: holly topping ; 7000 west william cannon drive; austin, TX 78735 ; 5123913905
• MDR Report Key: 14655154
• MDR Text Key: 294859603
• Report Number: 1020279-2022-02875
• Device Sequence Number: 1
• Product Code: JDG
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 07/11/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/10/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/08/2022
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention; Other
• Patient Age: 87 YR
• Patient Sex: Male