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

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

Patient Problem Pain (1994)

Event Date 05/22/2020

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: tyusuf erdem, md, gulhane training and research hospital.It was reported that patient underwent a revision surgery due pain after 5 years of implantation.

Manufacturer Narrative

Results of investigation: the study of yusuf erdem [1] reported that patient underwent a revision surgery due pain after 5 years of implantation.Various screws, sl plus and ep-fit plus implants are mentioned.None of the claimed article, which are intended to be used in treatment, weren't sent back for investigation.Since there is no explicit naming of batch numbers in the science reports no batch record review can be performed.A complaint history review could not be performed due to missing information about the explicit article.No article number or batch number is available.In the corresponding risk management file, the reported risk of a dislocation is mentioned and remains as anticipated.The risk of the sudek's atrohpy or post-operative condition will be added to the corresponding risk file.In our current instruction for use for hip implants 12.23 ed.05/16 delayed wound healing or morphological postoperative changes and dislocation of the implanted parts are mentioned as possible side effect and risk of an total hip arthroplasty.S+n will monitor the devices for similar issues.At the moment no further action is necessary.[1] yusuf erdem; total hip arthroplasty with rectangular stems and subtrochanteric transverse shortening osteotomy in crowe type iv hips: a restrospective study; (b)(6) hospital; (b)(6) 2019; https://doi.Org/10.1016/j.Artd.2019.03.002.

• Brand Name: UNKNOWN ORTHOPAEDIC RECONSTRUCTION DEV
• 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: 10293394
• MDR Text Key: 199452682
• Report Number: 9613369-2020-00147
• 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: 11/23/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/18/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 11/06/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention