MAUDE Adverse Event Report: SMITH & NEPHEW ORTHOPAEDICS AG UNKN. EP-FIT PLUS PLASTIC INSERT; PROSTHESIS,HIP,HEMI-,TRUNNION-BEARING,FEMORAL,METAL/POLYACETAL

Device Problem Degraded (1153)

Patient Problem Injury (2348)

Event Date 12/01/2018

Event Type  Injury  

Event Description

"total hip arthroplasty with rectangular stems and subtrochanteric transverse shortening osteotomy in crowe type iv hips: a retrospective study".Author: yusuf erdem, md , gulhane training and research hospital.It was reported that a patient underwent a revision surgery due to wear of the acetabular liner after 7 years of implantation.

Manufacturer Narrative

Results of investigation: the study of yusuf erdem et.Al.[1] reports surgeries on 26 hips, in 26 ep fit rexpol inserts, used in treatment, were implanted.It is reported, that in one case the patient suffered from wear of the insert.The part and the batch number of this device are not known.Therefore, the batch record review and a complaint history review could not be performed.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 medication documentation was provided, therefore, a thorough medical investigation could not be performed.Based on our investigations the failure mode cannot be confirmed and the root cause of the problem stays undetermined due to insufficient information.To date, no further actions will be taken.Smith and nephew will monitor the devices for further similar issues.[1]: erdem, y., bek, d., atbasi, z., neyisci, c., yildiz, c., & basbozkurt, m.(2019).Total hip arthroplasty with rectangular stems and subtrochanteric transverse shortening osteotomy in crowe type iv hips: a retrospective study.Arthroplasty today, 5(2), 234¿242.Https://doi.Org/10.1016/j.Artd.2019.03.002.

• Brand Name: UNKN. EP-FIT PLUS PLASTIC INSERT
• 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: 10317903
• MDR Text Key: 200225663
• Report Number: 9613369-2020-00151
• 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
• Report Date: 11/11/2020

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
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 06/29/2020
• Initial Date FDA Received: 07/23/2020
• Supplement Dates Manufacturer Received: 10/26/2020
• Supplement Dates FDA Received: 11/11/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention