MAUDE Adverse Event Report: SMITH & NEPHEW ORTHOPAEDICS AG UNKN. EP-FIT PLUS INSERT (UNKN. MATERIAL); PROSTHESIS, HIP, HEMI-, FEMORAL, METAL/POLYMER, CEMENTED OR UNCEMENTED

Catalog Number UNKN1101003

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

Patient Problem Unspecified Infection (1930)

Event Date 08/29/2019

Event Type  Injury  

Event Description

On the literature article named "titanium acetabular cementless cups combined with highly crosslinked polyethylene liner have very low rates of aseptic loosening", it was reported that, a third revision surgery was performed in patient number 3 due to a secondary infection after 10 months of the last revision.The liner and the cup were explanted.The outcome of the patient is unknown.

Manufacturer Narrative

The study of klasan et.Al.[1] reports a retrospective follow-up study on 67 hip cups in 64 patients.As this is a literature complaint, the parts, used in treatment, were not returned for investigation.It is reported, that in one case the patient received a third revision due to a secondary infection after 10 months of the last revision.The liner and the cup were explanted.The outcome of the patient is unknown.The outcome of the patient is unknown.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.A complaint history review was conducted.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]: klasan a, neri t, sen a, el-zayat bf, efe t, lahner m, heyse tj.Titanium acetabular cementless cups combined with highly crosslinked polyethylene liner have very low rates of aseptic loosening.Technol health care.2020;28(4):415-423.Doi: 10.3233/thc-191896.Pmid: 31796715.

• Brand Name: UNKN. EP-FIT PLUS INSERT (UNKN. MATERIAL)
• Type of Device: PROSTHESIS, HIP, HEMI-, FEMORAL, METAL/POLYMER, CEMENTED OR UNCEMENTED
• Manufacturer (Section D): SMITH & NEPHEW ORTHOPAEDICS AG; schachenallee 29; aarau CH-50 00; SZ CH-5000
• MDR Report Key: 11995530
• MDR Text Key: 256186764
• Report Number: 9613369-2021-00305
• Device Sequence Number: 1
• Product Code: KWY
• 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: 07/22/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/14/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: UNKN1101003
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 07/19/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention