MAUDE Adverse Event Report: SMITH & NEPHEW, INC. GII HA POR TIBIAL {} SZ 7 LT; PROSTHESIS, KNEE, PATELLO/FEMOROTIBIAL, SEMI-CONSTRAINED, UNCEMENTED, POROUS, CO

Model Number 71422088

Device Problems Improper or Incorrect Procedure or Method (2017); Loosening of Implant Not Related to Bone-Ingrowth (4002)

Patient Problems Failure of Implant (1924); Pain (1994); Synovitis (2094); Osteolysis (2377); Inadequate Osseointegration (2646); Swelling/ Edema (4577)

Event Date 02/27/2018

Event Type  Injury  

Manufacturer Narrative

Internal complaint reference: (b)(4).

Event Description

It was reported that, after an initial left tka had been performed on (b)(6) 2012 due to severe post-traumatic arthritis, the patient experienced the tibial prosthesis loosening, synovitis and osteolytic erosion under the medial tibial plateau.The patient underwent a left revision surgery on (b)(6) 2018.During this procedure, only the patella component was retained.The patient's outcome is unknown.

Manufacturer Narrative

Section h6 was updated.Section b4 was corrected.

Event Description

Bilateral patient.It was reported that, after an initial left tka on (b)(6) 2012, due to degenerative joint disease, genu varum malalignment with mild flexion contracture of the left knee.Plaintiff experiences tibial loosening and polyethylene wear, synovitis and osteolytic erosion under the medial tibial plateau.Plaintiff underwent a left revision surgery on (b)(6) 2018.Patient status is unknown.

Manufacturer Narrative

H3, h6: the device was not returned for evaluation but according to the clinical/medical findings the tibial loosening and the lack of fixation screws can be confirmed.The clinical/medical investigation concluded that, based on the documentation provided, it was suspected that the metallic morse taper as well as the polyethylene wear were contributing factors to the intraop findings with ¿significant osteolytic erosion under the medial tibial plateau¿; however, it is noted that the primary porous construct was implanted without tibial baseplate fixation screws as described by the genesis ii tks porous surgical technique which notes that appropriately sized screws are to be used in conjunction with the tibial baseplate and finned fixation peg.It is unknown to what extent the lack of fixation screws contributed to the mechanical instability with significant osteolysis, poly-wear, loosening, extensive synovitis and pain during the approximate 6 years in-vivo; however, the risk for micromotion and/or macromotion of the tibial construct would have been increased.The assessed patient impact was the noted mechanical loosening, osteolysis, accompanying symptoms, and intraoperative findings, as well as an anticipated transient rehabilitation phase.Further patient impact could not be determined as the current patient status is unknown.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 knee systems revealed that looseness of components, can result from trauma, improper implant selection, improper implant positioning, improper fixation, and/or migration of the components.Muscle and fibrous tissue laxity can also contribute to these conditions.Besides, surgical information is available upon request.The surgeon should be familiar with the technique, this has been identified as preoperative warnings and precautions.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.At this time, we have no reason to suspect that the product failed to meet any product specifications at the time of manufacture.Factors that could contribute to the reported event include abnormal motion over time, bone degeneration, size selected, loss of ingrowth, osteolysis and/or traumatic injury.The contribution of the device to the reported event could be corroborated since the tibia was loose and a revision surgery was required.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.

• Brand Name: GII HA POR TIBIAL {} SZ 7 LT
• Type of Device: PROSTHESIS, KNEE, PATELLO/FEMOROTIBIAL, SEMI-CONSTRAINED, UNCEMENTED, POROUS, CO
• 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: 15123037
• MDR Text Key: 296793465
• Report Number: 1020279-2022-03516
• Device Sequence Number: 1
• Product Code: MBH
• UDI-Device Identifier: 03596010496447
• UDI-Public: 03596010496447
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K030612
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 11/02/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/28/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 06/22/2019
• Device Model Number: 71422088
• Device Catalogue Number: 71422088
• Device Lot Number: 09EM06323
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 11/01/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/24/2009
• 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: (B)(4) / LOT: 09CHA0008A; PN: (B)(4) / LOT: 10GM00870; PN: (B)(4) / LOT: 12AM17245
• Patient Outcome(s): Required Intervention; Hospitalization
• Patient Age: 72 YR
• Patient Sex: Male