MAUDE Adverse Event Report: SMITH & NEPHEW, INC. UNKNOWN GENESIS II REVISION KNEE IMPL; PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL

Catalog Number UNKNOWN

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

Patient Problem Nerve Damage (1979)

Event Date 07/07/2021

Event Type  Injury  

Manufacturer Narrative

Internal complaint reference: (b)(4).Hines, jeremy t.Md1; lewallen, david g.Md1; perry, kevin i.Md1; taunton, michael j.Md1; pagnano, mark w.Md1; abdel, matthew p.Md1,a.Biconvex patellar components: 96% durability at 10 years in 262 revision total knee arthroplasties.The journal of bone and joint surgery 103(13):p 1220-1228, july 7, 2021.| doi: 10.2106/jbjs.20.01064.This complaint was opened by smith+nephew to document a patient complication identified through a review of clinical evidence from literature sources that includes reference to the use of a smith+nephew product.The reported issue(s) relate to known inherent procedural risks that are appropriately documented in our risk files.Smith+nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.Smith+nephew has no reason to suspect that the product failed to meet any specifications at the time of manufacture.Based on our review of all currently available information, we are unable to confirm a relationship between the reported event and the device or identify a definitive root cause.However, as the use of our product cannot be excluded as a potential cause or contributory factor to the reported issue, we are conservatively submitting this report in accordance with applicable regulations.If additional information becomes available that alters the conclusions of this report, a follow-up report will be submitted as required.

Event Description

It was reported that on literature review "biconvex patellar components 96% durability at 10 years in 262 revision total knee arthroplasties", after a tka revision surgery using a genesis inset biconvex patellar component, 2 patients experienced peroneal nerve palsy with subsequent improvement.It is unknown how these complications were treated.No further information is available.

Manufacturer Narrative

The devices were not returned for evaluation; therefore, devices analysis could not be performed.The clinical/medical investigation concluded that, per the complaint details, 2 patients (sited from a retrospective cohort study/literature review) experienced peroneal nerve palsy with subsequent improvement.It is unknown if interventions were required or how these complications were treated.As of the date of this medical investigation, clinical documentation has not been received and the current status of the patients are unknown.The images provided in the article have been interpreted within the text by one non-independent author and do not provide insight into this reported event; therefore, no further analysis of the imaging is required.Without patient specific medical documentation, definitive contributing factors to the reported peroneal nerve palsy could not be concluded; however, this is a known potential procedural complication and a component malperformance was not supported.The impact to the patients beyond those which were reported cannot not be determined based on the information provided in the literature, although ¿subsequent improvement¿ was reported.No further medical assessment can be rendered at this time.Devices specific identifiers were not provided.Therefore, an evaluation of the manufacturing records, complaint history review, instructions for use, risk management file and prior actions review could not be performed.At this time, we have no reason to suspect that the products failed to meet any specifications at the time of manufacture.Factors that could contribute to the reported event include procedural/user error, traumatic injury or patient medical history.Based on this investigation, the need for corrective action is not indicated.Should the devices or additional information be received, the complaint will be reopened.No further investigation is warranted for this complaint; however, we will continue to monitor for future complaints and investigate as necessary.We consider this investigation closed.

• Brand Name: UNKNOWN GENESIS II REVISION KNEE IMPL
• Type of Device: PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks rd.; memphis TN 38116
• Manufacturer (Section G): SMITH & NEPHEW, INC.; 1450 brooks rd.; memphis TN 38116
• Manufacturer Contact: holly topping ; 7000 west william cannon drive; austin, TX 78735 ; 5123913905
• MDR Report Key: 16876548
• MDR Text Key: 314642663
• Report Number: 1020279-2023-00987
• Device Sequence Number: 1
• Product Code: JWH
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Literature,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 06/02/2023

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
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 05/02/2023
• Initial Date FDA Received: 05/05/2023
• Supplement Dates Manufacturer Received: 06/01/2023
• Supplement Dates FDA Received: 06/02/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention