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

Device Problem Loose or Intermittent Connection (1371)

Patient Problem Injury (2348)

Event Type  Injury  

Event Description

In a literature review, was reported that in a research of the surface damage of retrieved oxidized zirconium implants, were used sixty-three oxzr components (43 tka, 20 tha).All components were manufactured by smith & nephew, and included both cruciate-retaining and posteriorly-stabilized tka designs.It is unknown how many patients were involved, and there is no information of any of the patients from who these components were explanted of.It was informed that 1 of the hip devices was retrieved due to loosening.There are no dates of explantation surgeries available.And there is unknown if some of these events have been reported in the past.

Manufacturer Narrative

The associated complaint device was not returned for evaluation.This event was reported from a literature review.After repeated requests, smith and nephew has been unable to obtain device details.Smith and nephew has an outstanding request with the reporter for information.As device details were not made available, a device history record review cannot be completed.Also, a complaint history review could not be performed due to lack of device information.Our clinical evaluation could not performed at this time as no clinical supporting documents were provided to conduct a thorough assessment of the reported issue.Based on the literature review, surface damage of retrieved oxidized zirconium knee and hip implants were observed.The tka components had a higher average surface roughness value compared with tha components.One tha component, revised following dislocation, showed catastrophic increase of 25x surface damage including destruction of the oxide layer and exposed zirconium substrate.The literature review states no correlation exists between the average surface roughness and either in vivo duration or bmi.Without clinically relevant documentation, the root cause of the reported events cannot be concluded.The patient impact beyond the reported revisions cannot be determined.Without the return of the actual product involved and no product information available, our investigation of this report is inconclusive.We will continue to monitor for future complaints and investigate as necessary.Should the device or additional information be received, this complaint will be reopened and reevaluated.Mimb review.Assess severity of complaint case to determine if additional actions or inputs are required for inclusion in the medical assessment.Determine if a medical assessment will be performed based on a review of the complaint details and further input from the medical director/designee.Reviewed during mimb.A medical investigation will be performed.Proceed based on information provided and/or available for the investigation; if no relevant clinical information is provided, recommend closure.Approved by dr.Luca orlandini and/or j.Templeton, medical director.A review of relevant clinical/medical information in the reported issue, inclusive of technique and patient information, to include, but not limited to: ¿patient information ¿surgical procedure/post-operative care review ¿device labeling (including technique guides, ifus, etc.) clinically relevant supporting documentation was not provided for inclusion in a medical investigation; therefore, a thorough medical assessment could not be performed.Based on the literature review, surface damage of retrieved oxidized zirconium knee and hip implants were observed.The tka components had a higher average surface roughness value compared with tha components.One tha component, revised following dislocation, showed catastrophic increase of 25x surface damage including destruction of the oxide layer and exposed zirconium substrate.The literature review states no correlation exists between the average surface roughness and either in vivo duration or bmi.Without clinically relevant documentation, the root cause of the reported events cannot be concluded.The patient impact beyond the reported revisions cannot be determined.No further medical assessment is warranted at this time.

• 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: 8452987
• MDR Text Key: 139884760
• Report Number: 1020279-2019-01198
• 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
• Report Date: 06/30/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Initial Date Manufacturer Received: 03/05/2019
• Initial Date FDA Received: 03/26/2019
• Supplement Dates Manufacturer Received: 06/26/2019
• Supplement Dates FDA Received: 06/30/2019
• Is This a Reprocessed and Reused Single-Use Device?: Yes
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention