MAUDE Adverse Event Report: SMITH & NEPHEW ORTHOPAEDICS AG UNKNOWN REFLECTION LINER; PROSTHESIS, HIP, HEMI-, TRUNNION-BEARING, FEMORAL, METAL/POLYACETAL

Lot Number 0508.02.4155

Device Problem Osseointegration Problem (3003)

Patient Problem Injury (2348)

Event Date 03/08/2019

Event Type  Injury  

Event Description

It was reported that after a right thr surgery, the patient experienced pain caused by symptomatic osteolysis of the acetabulum and proximal femur on the right by abrasion from polyethylene.Revision surgery was performed in order to remove the shell, insert and the head.The patient outcome is unknown.

Manufacturer Narrative

A revision surgery was reported with an ep-fit shell (75003902), an ep-fit pe insert (75003961) and an unknown ceramic ball head forte.It was reported that the patient experienced pain which was caused by osteolysis in the acetabulum ultimately due to abrasion of the ep-fit pe insert and it was assumed in the operative report that the cup inclination may have contributed to the relatively early failure of the insert.The complaint devices, used in treatment, were returned for investigation.A material inspection of the complaint parts was performed.The cup surface showed signs of bone ongrowth distributed over the whole cup surface.The surface of the polyethylene (pe) insert showed signs of wear and scratches, it is unclear if the scratches were caused during implantation or the explantation procedure.The maximum linear wear of the ep-fit pe insert was determined as 1.076 mm at approx.4 mm below the rim using a roundness machine.Based on an in vivo time of 13 years, a linear wear of 1.076 mm corresponds to a wear rate of 0.083 mm/y.This is in line with wear rates of uhmwpe hip cup inserts reported in literature.According to different sources, osteolysis is rarely observed at wear rates below 0.1 mm/y.As alternative product, a highly crosslinked polyethylene insert could have been used in this case.Based on the available information it is not possible to assess whether the use of a highly crosslinked polyethylene insert would have prevented the development of osteolysis in the observed time frame.Additionally, discoloration of the bearing regions was observed for the insert.For most cases, the root cause for yellowing in the bearing regions is lipid absorption.The determination of the cause for the discoloration would require destructive methods such as extraction of the lipids in a solvent or infra-red spectroscopy to measure oxidation.In order to perform a destructive analysis, an authorization of the patient and of the national competent authorities is required.These analyses were therefore not performed.The complaint history review and production documentation review could not be performed because the lot numbers of the complaint part are unknown since the insert was stuck in the shell and the parts could not be separated in a non-destructive way.In the current ifu lit.No.12.23 ed.05/16, wear and loosening of the implant are listed as possible side effect.The severity and the failure mode are covered through our risk management.On the basis of the provided medical documents, it is unknown whether there was any traumatic injury or if the patient had any underlying comorbidities which may have contributed to the revision.Based on the conducted investigation, it is seen that this issue is a known inherent risk of the device which is listed as possible adverse effects in the ifu of the product.Smith+nephew will continue to monitor for similar issues.No further actions are deemed necessary at this time.The complaint parts will be retained.

Manufacturer Narrative

Concomitant device information was updated.

• Brand Name: UNKNOWN REFLECTION LINER
• Type of Device: PROSTHESIS, HIP, HEMI-, TRUNNION-BEARING, FEMORAL, METAL/POLYACETAL
• Manufacturer (Section D): SMITH & NEPHEW ORTHOPAEDICS AG; schachenallee 29; aarau CH-50 00; SZ CH-5000
• MDR Report Key: 10153828
• MDR Text Key: 195122601
• Report Number: 9613369-2020-00118
• 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: company representative,foreig
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 11/24/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/15/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Lot Number: 0508.02.4155
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 09/10/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: 75004171
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Weight: 68