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 Problems Bone Fracture(s) (1870); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 04/16/2021

Event Type  Injury  

Manufacturer Narrative

Smith & nephew, inc.Is submitting this report pursuant to the provisions of 21 cfr, part 803.This report may be based upon information which smith & nephew, inc.Has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, smith & nephew, inc., or its employees, that the report constitutes an admission that the device, smith & nephew, inc., or its employees caused or contributed to the potential event described in this report.

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¿.One adverse event was reported due to an intraoperative crack while using unkn ep-fit plus shell.

Manufacturer Narrative

H3, h6: 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.It is reported, that in one case the patient suffered from an intraoperative crack while using unkn ep-fit plus shell.The part and the batch number of this device are not known.Therefore, it is not possible to investigate whether the reported device met manufacturing specification upon release for distribution.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.As no device was received for investigation, a visual inspection could not be performed.No patient information nor any other medical documentation was provided, therefore, a thorough medical investigation could not be performed.Based on our investigations the failure mode and the relationship between the device and the reported event cannot be confirmed.Due to insufficient information it is not possible to speculate about factors which could have contributed to the reported event.To date, no further actions will be taken.Should additional information become available, this complaint will be reassessed.Smith and nephew will monitor the devices for further similar issues.[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.

• Brand Name: UNKN. EP-FIT PLUS SHELL
• Type of Device: EP-FIT PLUS SHELL
• Manufacturer (Section D): SMITH & NEPHEW ORTHOPAEDICS AG; schachenallee 29; aarau CH-50 00; SZ CH-5000
• MDR Report Key: 11793822
• MDR Text Key: 249665409
• Report Number: 9613369-2021-00184
• 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: literature
• Type of Report: Initial,Followup
• Report Date: 05/31/2021

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: 05/31/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention