MAUDE Adverse Event Report: SMITH & NEPHEW ORTHOPAEDICS AG RT-PLUS MOD FEMORAL COMP. RIGHT 8 CEM; PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL

Catalog Number 75005552

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

Patient Problems Loss of Range of Motion (2032); Fibrosis (3167)

Event Date 02/28/2024

Event Type  Injury  

Event Description

It was reported that, after a tka revision surgery performed on (b)(6) 2013, the patient has progressive arthrofibrosis and experienced a profoundly stiff knee.A second revision surgery was performed on (b)(6) 2024 to address this adverse event.Among the explanted devices was a ten year old plus hinge was that was virtually fused.Patient's current health status is unknown.

Manufacturer Narrative

Internal complaint reference: (b)(4).

Event Description

It was reported that, after a tka revision surgery was performed on (b)(6) 2013, the patient presented progressive arthrofibrosis and experienced a profoundly stiff knee.A second revision surgery was performed on (b)(6) 2024 to address this adverse event.Among the explanted devices, there was a ten-year-old plus hinge was that was virtually fused.Patient's current health status is unknown.

Manufacturer Narrative

H3, h6: the device was not returned for investigation.A product evaluation was not possible.A review of the production documentation did not detect any deviation that could have contributed to the reported failure mode.The complaint history review for the complaint device revealed no additional complaints for the affected batch nor additional complaints for the same product number over the past 12 months with similar failure mode.A review of past corrective actions was performed.No further escalation is required.A review of the risk management documentation verifies the failure mode, occurrence and severity of the reported issue.The instructions for use (lit.No.12.24, ed 03/21) states arthritis, discomfort, failure of implant, fibrosis / adhesion(s), loss of range of motion, muscular rigidity, scar tissue resulting from a knee arthroplasty.No clinically sufficient data was provided to perform a medical investigation.The performed investigation does not lead to an accurately determined cause.There is no evidence that the reported devices failed to meet manufacturing specifications upon release for distribution.Due to insufficient information, it is not possible to indicate factors which could have contributed to the reported event.Nevertheless, smith + nephew will continue to monitor this device for similar issues.This complaint will be reopened should additional information or the device be received.H11- corrected data.B5- describe event or problem.D8- device available for evaluation.

Manufacturer Narrative

Corrected data: d9 & h3 (sample returned for analysis), h6 (type of investigation, type of investigation).Updated results of investigation: it was reported that, after a total knee arthroplasty revision surgery, the patient has progressive arthrofibrosis and experienced a profoundly stiff knee.A second revision surgery was performed to address this adverse event.Among the explanted devices was a ten year old plus hinge was that was virtually fused.The complaint rt-plus mod femoral comp.Right 8 cem, and the tibia base plate have been returned for evaluation.The inlay between the femoral and tibial implant has not been returned.Upon visual inspection, indentation marks, scratches, deformations and residues of probably cement and/or body fluid have been observed on the complaint device.Matt material can be seen inside the hinge canal, which is likely leftover cement.It is suspected, that the deformations and residues of cement prevents the hinge from a smooth movement.A review of the production documentation did not detect any deviation that could have contributed to the reported failure mode.The complaint history review for the complaint device revealed no additional complaints for the affected batch nor additional complaints for the same product number over the past 12 months with similar failure mode.A review of past corrective actions was performed.No further escalation is required.A review of the risk management documentation verifies the failure mode, occurrence and severity of the reported issue.The anticipated risk level is still adequate.The instructions for use (lit.No.12.24, ed 03/21) states arthritis, discomfort, failure of implant, fibrosis / adhesion(s), loss of range of motion, muscular rigidity, scar tissue resulting from a knee arthroplasty.As of the date of this medical investigation, the requested clinical documentation has not been provided; therefore, definitive contributing factors could not be concluded.However, arthrofibrosis and/or scar tissue formation is a known post-surgical occurrence and is not indicative of a device malperformance.Although the revision was reportedly due to the progressive arthrofibrosis/profoundly stiffness, the clinical root cause of the progression cannot be determined based on the limited information provided.The patient impact beyond the reported stiffness secondary to progressive arthrofibrosis with a ¿virtually fused¿, profoundly stiff knee/stiff bearing construct and subsequent revision cannot be determined.The performed investigation does not lead to an accurately determined cause.However, the returned femoral explant shows a large collection of cement and some indentations.The arthrofibrosis and/or scar tissue formation, the cement excess, the indentations marks as deformities of the plastic part of the hinge, as well as any other mechanical damage from high load activities, could result as a multiple set of factors which can contribute to the alleged fault.There is no evidence that the reported devices failed to meet manufacturing specifications upon release for distribution.The need for further actions is not indicated.Nevertheless, smith+nephew will continue to monitor this device for similar issues.The returned devices will be retained.

• Brand Name: RT-PLUS MOD FEMORAL COMP. RIGHT 8 CEM
• Type of Device: PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL
• Manufacturer (Section D): SMITH & NEPHEW ORTHOPAEDICS AG; schachenallee 29; aarau CH-50 00; SZ CH-5000
• Manufacturer (Section G): SMITH & NEPHEW ORTHOPAEDICS AG; schachenallee 29; aarau CH-50 00; SZ CH-5000
• Manufacturer Contact: holly topping ; 7000 west william cannon drive; austin, TX 78735 ; 5123913905
• MDR Report Key: 18951205
• MDR Text Key: 338258959
• Report Number: 9613369-2024-00027
• Device Sequence Number: 1
• Product Code: JWH
• UDI-Device Identifier: 07611996042832
• UDI-Public: 7611996042832
• Combination Product (y/n): N
• Reporter Country Code: AS
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 04/11/2024

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 Expiration Date: 02/07/2020
• Device Catalogue Number: 75005552
• Device Lot Number: H1300958
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 02/28/2024
• Initial Date FDA Received: 03/21/2024
• Supplement Dates Manufacturer Received: 04/09/2024
• Supplement Dates FDA Received: 04/11/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/07/2013
• 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
• Treatment: 75005486/0609134891/RT-PLUS TIBIAL INSERT 6/11MM; 75005515/G1207444/RT-PLUS MODULAR STEM CONICAL 95M; 75005522/G1022031/RT-PLUS MOD STEM STRAIGHT 16/120; 75005561/H1300754/RT-PLUS MOD TIBIAL COMPONENT 6 C
• Patient Outcome(s): Required Intervention
• Patient Sex: Male