MAUDE Adverse Event Report: SMITH & NEPHEW, INC. HIP IMPLANT; PROSTHESIS, HIP, HEMI-, TRUNNION-BEARING, FEMORAL, METAL/POLYACETAL

Device Problem Material Deformation (2976)

Patient Problem Injury (2348)

Event Date 01/01/1901

Event Type  Injury  

Event Description

It was reported that a revision surgery was performed due to wear of the liner and head.

Manufacturer Narrative

It was reported from a literature review that ten years following implantation the patient underwent a 2-stage revision procedure due to aseptic loosening, periprosthetic joint infection and metallosis.The affected complaint devices, used in treatment, were not returned for evaluation.Therefore a product analysis could not be performed.As device information was not made available, device history record and complaint history review cannot be completed.There is no information that would suggest the devices failed to meet specifications.A relationship, if any, between the devices and the reported incident could not be corroborated.A medical analysis noted that the mri images provided in the article noted ¿an extensive bone reaction with cystic lesions in the proximal femur and acetabulum¿ and the ct images noted ¿extensive bone reaction, with cortical expansion and cystic lesions in both the proximal femur and the acetabulum, and a flattened oxinium femoral head.¿ per the article during the first stage procedure black material surrounding the implant was noted and extensive bone destruction involving the proximal third of the femur and the acetabulum.Intraoperative photos were provided to confirm the reported.During the second stage procedure, ¿a tumor prosthesis was used to replace the proximal femur and acetabulum.¿ the article concluded that patients with an oxinium femoral head should be assessed for accelerated polyethylene wear and if present the patient should considered for early revision before oxinium femoral head wear occurs to prevent extensive bone destruction as a result of zirconium deposition.

• Brand Name: HIP IMPLANT
• Type of Device: PROSTHESIS, HIP, HEMI-, TRUNNION-BEARING, FEMORAL, METAL/POLYACETAL
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks road; memphis TN 38116
• MDR Report Key: 9490496
• MDR Text Key: 171976195
• Report Number: 1020279-2019-04482
• Device Sequence Number: 1
• Product Code: JDH
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,literatur
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 07/12/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/18/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Date Manufacturer Received: 07/08/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 35 YR