MAUDE Adverse Event Report: SMITH & NEPHEW ORTHOPAEDICS AG UNKN. EP-FIT PLUS SHELL

Catalog Number UNKN1101002

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Joint Dislocation (2374)

Event Date 04/16/2021

Event Type  Injury  

Event Description

It was reported that on literature review ¿hip international 2013, the fate of sagittal alignment in tapered uncemented femoral components in total hip arthroplasty: 889 hips followed for a minimum of 10 years¿.Twenty-one adverse event were reported due to dislocation while using unkn ep-fit plus shell components.Six of them were treated via revision surgery.It is unknown if / how the other 15 dislocations were treated.

Manufacturer Narrative

The study of garcía-rey e.[1] reports surgeries on 889 hips.In 330 cases a sl stem was implanted in combination with an ep-fit cup.Twenty-one adverse event were reported due to dislocation while using unkn ep-fit plus shell components.Six of them were treated via revision surgery.It is unknown if / how the other 15 dislocations were treated.As this is a literature complaint, the parts used in treatment, were not returned for investigation, hence the product evaluation could not be conducted.A complaint history review was performed.The batch record review could not be performed as the batch number of the device is not known.The reported failure mode might occur in some cases, which is stated as a side effect in the ifu lit.No.12.23 ed.05/16.The severity and the failure mode are covered through our risk management.No patient information nor any other medication documentation was provided, therefore, a thorough medical investigation could not be performed.Based on the conducted investigation the failure mode could not be confirmed independently.A relationship between the reported event and the device cannot be confirmed.Due to insufficient information it is neither possible to investigate whether the reported device met manufacturing specifications upon release for distribution nor to speculate about factors which could have contributed to the reported event.The root cause of the problem stays undetermined.To date, no further actions will be taken.Smith and nephew will monitor the devices for further similar issues.This investigation is considered closed.[1]: garcía-rey e.The fate of sagittal alignment in tapered uncemented femoral components in total hip arthroplasty: 889 hips followed for a minimum of 10 years.Hip int.2020 jan 7:1120700019895983.Doi: 10.1177/1120700019895983.Epub ahead of print.Pmid: 31908180.

• Brand Name: UNKN. EP-FIT PLUS SHELL
• Type of Device: UNKN. EP-FIT PLUS SHELL
• Manufacturer (Section D): SMITH & NEPHEW ORTHOPAEDICS AG; schachenallee 29; aarau CH-50 00; SZ CH-5000
• MDR Report Key: 11794504
• MDR Text Key: 249664895
• Report Number: 9613369-2021-00192
• Device Sequence Number: 1
• Product Code: LWJ
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: literature
• Type of Report: Initial,Followup
• Report Date: 05/28/2021

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?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: UNKN1101002
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 04/16/2021
• Initial Date FDA Received: 05/07/2021
• Supplement Dates Manufacturer Received: 05/28/2021
• Supplement Dates FDA Received: 05/28/2021
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention