MAUDE Adverse Event Report: SMITH & NEPHEW, INC. CONTOUR ACET RING IMPL; PROSTHESIS, KNEE, FEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, METAL/POLYMER

Catalog Number UNKNOWN

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

Patient Problem Joint Laxity (4526)

Event Date 03/05/2019

Event Type  Injury  

Manufacturer Narrative

(b)(4).

Event Description

It was documented on the paper that the s&n orthopaedic reconstruction devices were applied to 56 patients, 1 of these patients presented aseptic loosening of the cage at 1 year, and revision surgery was recommended.Patient rejected the surgery and was lost to follow-up.All available information has been disclosed.If additional information should become available, a supplemental report will be submitted accordingly.

Manufacturer Narrative

The affected complaint device, used in treatment, was not returned for evaluation.Therefore, a product analysis could not be performed.As device information was not made available, device history record, risk management review and complaint history review cannot be completed.There is no information that would suggest the device failed to meet specifications.According to clinical/medical investigation, the data presented in the article refers to a patient who presented with aseptic loosening of the cage at 1 year; however, rejected the proposed revision surgery.Reportedly, the patient was lost to follow-up.Responses to the requested clinical documentation had not been received as of the date of this investigation, therefore further investigation could not be performed.The physician referenced in the abstract provided an analysis of all of the attached images; therefore, no further interpretation of the attached images are required.The root cause and/or patient outcome beyond that which was documented in the article could not be confirmed nor concluded.No further medical assessment is warranted at this time.A relationship, if any, between the device and the reported incident could not be corroborated.No medical documents were received for investigation.Therefore, no medical assessment can be performed at this time.Based on this investigation, the need for corrective action is not indicated.No further investigation is warranted for this complaint; however we will continue to monitor for future complaints and investigate as necessary.Should the device or additional information be received, the complaint will be reopened.

• Brand Name: CONTOUR ACET RING IMPL
• Type of Device: PROSTHESIS, KNEE, FEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, METAL/POLYMER
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks rd.; memphis TN 38116
• MDR Report Key: 11091264
• MDR Text Key: 224243933
• Report Number: 1020279-2020-07953
• Device Sequence Number: 1
• Product Code: HRY
• 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: 04/22/2021

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?: No
• Device Operator: Health Professional
• Device Catalogue Number: UNKNOWN
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 12/03/2020
• Initial Date FDA Received: 12/29/2020
• Supplement Dates Manufacturer Received: 03/24/2021
• Supplement Dates FDA Received: 04/22/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: ALL-POLY CUP
• Patient Outcome(s): Hospitalization; Required Intervention