MAUDE Adverse Event Report: SMITH & NEPHEW ORTHOPAEDICS AG TC PRIM/TC REV TIB INSERT TC PS 4/19; PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAIN, CEMENT, POLY/MET/POLY

Model Number 75005186

Device Problems Fracture (1260); Material Twisted/Bent (2981)

Patient Problems Fall (1848); Failure of Implant (1924); Pain (1994); Synovitis (2094); Arthralgia (2355); Joint Laxity (4526)

Event Date 03/07/2022

Event Type  Injury  

Event Description

It was reported that, after a tka had been performed on an unspecified date, a high-thickness tc-plus insert dissociated from the tibial baseplate as the fixation screw fractured.A revision surgery was required to address this event.Further details are unknown.All available information has been disclosed.If additional information should become available, a supplemental report will be submitted accordingly.

Manufacturer Narrative

Smith & nephew is submitting this report pursuant to the provisions of 21 c.F.R.Part 803.This report may be based upon information which smith & nephew has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, smith & nephew, or its employees, that the report constitutes an admission that the device, smith & nephew or its employees caused or contributed to the potential event described in this report.(b)(4).

Event Description

It was reported that, after a right tka second revision had been performed on (b)(6) 2010, the patient sustained a fall (around on (b)(6) 2021) on her right knee and started experiencing pain (especially with heave loads and climbing stairs), as well as gross instability of the knee.An x-ray examination carried out on (b)(6) 2022 revealed a high-thickness tc-plus insert that dissociated from the tibial baseplate as the fixation screw fractured.A third revision surgery was performed on (b)(6) 2022 to address this incident.During this procedure, the prosthesis was replaced with a cemented modular right knee with a 11mm inlay.The explanted insert has a high wear backside; and according to a preliminary analysis conducted by a third surgeon, it looks like it was not properly engaged.The patient current health status is unknown.

Manufacturer Narrative

Additional information: g4 (510k).Corrected data: d4 (catalog number, lot number, expiration date, udi number), e4 (submitter did not send report to fda), h6 (health effect - clinical code).

Manufacturer Narrative

Section h10: it was reported that, after a right tka second revision had been performed on (b)(6) 2010, the patient sustained a fall (around on (b)(6) 2021) on her right knee and started experiencing pain (especially with heave loads and climbing stairs), as well as gross instability of the knee.An x-ray examination carried out on (b)(6) 2022 revealed a high-thickness tc-plus insert that dissociated from the tibial baseplate as the fixation screw fractured.A third revision surgery was performed on (b)(6) 2022 to address this incident.During this procedure, the prosthesis was replaced with a cemented modular right knee with a 11mm inlay.The explanted insert has a high wear backside; and according to a preliminary analysis conducted by a third surgeon, it looks like it was not properly engaged.The device use in treatment 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.A complaint history review was performed, there are no similar incidents, therefore this is an isolated event.The occurrence of the reported failure mode is anticipated with a low risk level as per risk management.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 states history of falls as a risk factor influences the success of the operation, joint instability as a potential adverse device effect and fracture, breakage and detachment of device or device component as a potential medical device problem in combination with the implantation of a knee prosthesis.Based on the information provided, the clinical root cause of the reported right knee pain, gross instability, inlay dissociation from tibia baseplate with reported screw fracture is possibly related to the reported ¿fall on the right knee,¿ which is fourteen months prior the revision and subsequent ¿loosening of the screw in the area of the inlay fixation.¿, but cannot confirm if the loosening led to the fall.The patient impact beyond the reported fall, symptoms and revision cannot determined.The performed investigation do 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 speculate about factors which could have contributed to the reported event.The need for corrective action is not indicated.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.Section h6 (health effect - clinical code) was updated.Internal complaint reference number: (b)(4).

Manufacturer Narrative

Section h10: it was reported that, after a right total knee arthroplasty second revision had been performed on (b)(6) 2010, the patient sustained a fall (around (b)(6) 2021) on her right knee and started experiencing pain (especially with heave loads and climbing stairs), as well as gross instability of the knee.An x-ray examination carried out on (b)(6)2022 revealed a high-thickness tc-plus insert that dissociated from the tibial baseplate as the fixation screw fractured.A third revision surgery was performed on (b)(6) 2022 to address this incident.During this procedure, the prosthesis was replaced with a cemented modular right knee with a 11mm inlay.The explanted insert has a high wear backside; and according to a preliminary analysis conducted by a third surgeon, it looks like it was not properly engaged.The complaint device used in treatment was returned for investigation.A visual evaluation of the device was conducted, and it was concluded that the complaint device returned with the screw inside the insert.The femur implant from smith and nephew, and the tibia component which is not from smith and nephew returned, too.There is no fracture at the screw, but the thread is damaged.It is further investigation necessary to check if the thread of the tibia component is compatible with the screw from the insert.Therefore, a material analysis of the tibia thread was performed, and it was concluded that the debris in the screw hole in fact comes from the screw and that there is evidence that the two components were in fact joined at one point.The screw metal is softer than alloy of the tibial plate, which explains why the thread on screw is worn, whereas the thread in screw hole is still intact.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.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 history of falls as a risk factor that influences the success of the operation, joint instability as a potential adverse device effect and fracture, breakage and detachment of device or device component as a potential medical device problem in combination with the implantation of a knee prosthesis.Smith&nephew implants and implant components must not be combined with other manufacturer implants and should always be implanted using smith&nephew surgical instruments.All liability is excluded for the unauthorized use of third-party products.Based on the medical information provided, the clinical root cause of the reported right knee pain, gross instability, inlay dissociation from tibia baseplate with reported screw fracture is possibly related to the reported ¿fall on the right knee,¿ which is fourteen months prior the revision and subsequent ¿loosening of the screw in the area of the inlay fixation.¿ but cannot confirm if the loosening led to the fall.The patient impact beyond the reported fall, symptoms and revision cannot determined.The patient current health status is unknown.There is no indication that the reported device failed to meet manufacturing specifications upon release for distribution.The root cause of the event can be attributed to an off-label, unapproved and contraindicated use of the device by using it with other other manufacturer implants.Specific factors known to contribute to the alleged fault are excessive physical activity levels, unreasonable stress on replacement system, excessive patient weight, trauma to the joint replacement, excessive force, misuse and general wear and tear.The need for further actions is not indicated.Nevertheless, smith+nephew will continue to monitor this device for similar issues.The returned device will be retained.Internal complaint reference number: (b)(4).

• Brand Name: TC PRIM/TC REV TIB INSERT TC PS 4/19
• Type of Device: PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAIN, CEMENT, POLY/MET/POLY
• 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: 16189316
• MDR Text Key: 307560325
• Report Number: 9613369-2023-00007
• Device Sequence Number: 1
• Product Code: JWH
• UDI-Device Identifier: 07611996073614
• UDI-Public: 07611996073614
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: K000666
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Health Professional,User Facility
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 06/02/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/17/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 08/30/2012
• Device Model Number: 75005186
• Device Catalogue Number: 75005186
• Device Lot Number: 0507133112
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer 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
• Treatment: PN: 75004792 / LOT: G0911669.
• Patient Outcome(s): Other
• Patient Age: 68 YR