MAUDE Adverse Event Report: SMITH & NEPHEW, INC. ZUK UNI TIB BASE SZ 3 RM/LL; PROSTHESIS, KNEE, FEMOROTIBIAL, NON-CONSTRAINED, CEMENTED, METAL/POLYMER

Catalog Number 00584200302

Device Problem Fracture (1260)

Patient Problems Failure of Implant (1924); Pain (1994); Foreign Body In Patient (2687)

Event Date 03/14/2023

Event Type  Injury  

Manufacturer Narrative

Internal complaint reference: (b)(4).

Event Description

It was reported that, after an unicompartmental knee arthroplasty performed approximately three years ago, the patient woke up and when attempted to get out of bed, the knee locked in a bent position.As he attempted to straighten his leg, he heard a pop and felt something break.The patient started to present pain and it was confirmed via x-rays that part of the tibial component fractured.A revision surgery was performed on (b)(6) 2023 to solve this adverse event.The patient is still recovering and using crutches.

Manufacturer Narrative

The device was not returned for evaluation.However, the photographs were reviewed, and revealed that one side of the tibial baseplate has fractured off.The clinical/medical investigation concluded that, based on the information provided, the clinical root cause of the reported, ¿tibial component fractured,¿ cannot be definitively concluded.Two x-rays show a linear radiodense object in/around the knee joint area; therefore, a potential foreign body cannot be ruled out.Explant photo images show the tibial baseplate component fracture: however, ¿no additional information is available,¿ including no written interpretation of the x-rays.A mixed knee system construct cannot be ruled out as a contributing factor to this event as the femoral component appears to be a stride femoral component which is manufactured by blue-belt technologies.Per the surgical technique, ¿the stride knee system is designed as a system and does not allow the substitution of components from other systems and manufacturers.¿ the patient¿s reported symptoms (¿knee locked in a bent position¿attempted to straighten¿heard a pop and felt something break¿ and pain) were likely caused by the tibial component fracture or either a result of the fracture.Per case details, ¿the patient is still recovering and using crutches.¿ regarding the side discrepancy, the (b)(6) 2023 radiographs appear to be of a left uni knee/medial replacement with a radiodense object in anterior of knee joint, while the (b)(6) 2023 x-ray (labeled right side, shows a left tka with a radiodense object posterior of knee joint, while the photo of an explanted tibial component is labeled "rt med/lt lat" (not left medial, as appears in the (b)(6) 2023 image).The patient impact includes revision with conversion to a total knee after a possible contralateral placement of the tibial baseplate component, tibial component breakage in the presence of a mixed manufacturer construct/knee systems, and the reported patient symptoms including pain as well as a possible retained foreign body.No further medical assessment can be rendered at this time.A review of the production order did not reveal a manufacturing abnormality that could have caused or contributed to the reported incident.A review of complaint history for the part number over the past 12 months and for the batch number based on historical data of the device did not reveal similar events for the listed device.A review of the instructions for use documents for zuk unicompartmental knee revealed that loosening or fracture/damage of the prosthetic knee components has been identified as an adverse effect.A review of the risk management file revealed this failure mode was previously identified.The anticipated risk level is still adequate.A historical review concluded that there are no prior actions related to this product and event.According with material specification, raw material requirements shall be met.A number of mechanical tests shall be performed in order to meet the required strength values.At this time, we have no reason to suspect that the product failed to meet any specifications at the time of manufacture.Factors that could contribute to the reported event include using a mixed knee system construct, patient anatomy, abnormal loading of limb, excessive forces and/or traumatic injury.Based on this investigation, the need for corrective action is not indicated.Should the device 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.

Manufacturer Narrative

Section h3, h6: the device was not returned for evaluation.However, the photographs were reviewed, and revealed that one side of the tibial baseplate has fractured off.The clinical/medical investigation concluded that the clinical root cause of the reported, ¿tibial component fractured,¿ cannot be definitively concluded; however, the mixed knee system construct cannot be ruled out as a contributing factor to this event as the femoral component is a stride femoral component which is manufactured by blue-belt technologies.Per the surgical technique, ¿the stride knee system is designed as a system and does not allow the substitution of components from other systems and manufacturers.¿ two x-rays show a linear radiodense object in/around the knee joint area and explant photo images show the tibial baseplate component fracture which correlates with the revision operative report.The patient¿s reported symptoms were likely caused by the tibial component fracture or either a result of the fracture.Per case details, ¿the patient is still recovering and using crutches.¿ regarding the side discrepancy, the (b)(6) 2023 radiographs appear to be of a left uni knee/medial replacement with a radiodense object in anterior of knee joint, while the (b)(6) 2023 x-ray (labeled right side, shows a left total knee arthroplasty with a radiodense object posterior of knee joint, which correlates with the left revision/conversion to total knee arthroplasty operative report.The photo of an explanted tibial component is labeled "rt med/lt lat" (not left medial, as appears in the (b)(6) 2023 image).The patient impact includes revision with conversion to a total knee after a possible contralateral placement of the tibial baseplate component, tibial component breakage in the presence of a mixed manufacturer construct/knee systems, prolonged operative time, and the reported patient symptoms including pain and the retained foreign body in the ¿posterolateral soft tissues¿ after capsule flushing and unsuccessful retrieval attempts.Unfortunately, further patient impact/additional intervention(s) cannot be ruled out due to the potential for the foreign body to migrate.A review of the production order did not reveal a manufacturing abnormality that could have caused or contributed to the reported incident.A review of complaint history for the part number over the past 12 months and for the batch number based on historical data of the device did not reveal similar events for the listed device.A review of the instructions for use documents for zuk unicompartmental knee revealed that loosening or fracture/damage of the prosthetic knee components has been identified as an adverse effect.A review of the risk management file revealed this failure mode was previously identified.The anticipated risk level is still adequate.A historical review concluded that there are no prior actions related to this product and event.According with material specification, raw material requirements shall be met.A number of mechanical tests shall be performed in order to meet the required strength values.At this time, we have no reason to suspect that the product failed to meet any specifications at the time of manufacture.Factors that could contribute to the reported event include using a mixed knee system construct, patient anatomy, abnormal loading of limb, excessive forces and/or traumatic injury.Based on this investigation, the need for corrective action is not indicated.Should the device 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.

Event Description

It was reported that, after an unicompartmental knee arthroplasty performed on (b)(6) 2020, the patient woke up and when attempted to get out of bed, the knee locked in a bent position.As he attempted to straighten his leg, he heard a pop and felt something break.The patient started to present pain and it was confirmed via x-rays that part of the tibial component fractured.A revision surgery was performed on (b)(6) 2023 to solve this adverse event.The patient is still recovering and using crutches.

• Brand Name: ZUK UNI TIB BASE SZ 3 RM/LL
• Type of Device: PROSTHESIS, KNEE, FEMOROTIBIAL, NON-CONSTRAINED, CEMENTED, METAL/POLYMER
• 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: 17597160
• MDR Text Key: 321667911
• Report Number: 1020279-2023-01638
• Device Sequence Number: 1
• Product Code: HSX
• UDI-Device Identifier: 00885556619766
• UDI-Public: 00885556619766
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K033363
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Consumer,Health Professional,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 12/19/2023
• 2 Devices were Involved in the Event: 1 2

1 Patient was Involved in the Event

• Date FDA Received: 08/22/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 00584200302
• Device Lot Number: 63828366
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 12/15/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/01/2017
• 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
• Patient Age: 54 YR
• Patient Sex: Male
• Patient Weight: 77 KG