MAUDE Adverse Event Report: SMITH & NEPHEW, INC. GII NON-MOD CEM C/R FEM SZ5 LT; PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL

Catalog Number	71420072
Medical Device Problem Code	Loosening of Implant Not Related to Bone-Ingrowth (4002)
Health Effect - Clinical Codes	Inadequate Osseointegration (2646); Joint effusion (4849)
Date of Event	06/19/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that, after a left tka surgery performed on (b)(6) 2015, the patient experienced instability, knee effusion and loosening of femoral component.A revision surgery was performed on (b)(6) 2023 to address this adverse event.During the surgery it was noticed that the cement had not adhered to the gii non-mod cem c/r fem sz5 lt, as it could be lifted from the femur bone with the bare hand.Current health status of the patient is unknown.
Additional Manufacturer Narrative
Internal complaint reference: (b)(4).
Additional Manufacturer Narrative
Additional information: h6 (component code, type of investigation, investigation findings, investigation conclusions).Results of investigation: the device was not returned for evaluation; therefore, a device analysis could not be performed.The clinical/medical investigation concluded that due to the lack of supporting clinical documentation, the definitive clinical root cause of the reported adverse event could not be determined.Of note, the implants were in situ for approximately eight years prior to the onset of symptoms.A revision surgery was performed to address this issue and the patient health status is good.The patient impact was the reported instability, knee effusion, loosening of femoral component, the subsequent revision, and the expected post-operative convalescence period.Should any additional relevant patient information be provided, this cause would be re-assessed.As the part and batch number information provided did not match into the system, a device history record review could not be performed.A review of complaint history did not reveal similar events for the listed device over the previous 12 months.As mentioned, the part and batch number information provided did not match into the system, however the review was performed and did not reveal similar events for the part number.This failure mode will be monitored for future complaints for any necessary corrective actions.A review of the instructions for use documents for knee systems revealed that looseness of components can occur as a 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.This has been identified as a possible 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.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 abnormal motion over time, inadequate integration between the cement and bone/implant, 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.Corrected data: b1 (type of event), b5 (narrative), h3 (device not received for analysis), d8 (device available for evaluation?).
Event or Problem Description
It was reported that, after a left tka surgery performed on (b)(6) 2015, the patient experienced instability, knee effusion and loosening of femoral component.A revision surgery was performed on (b)(6) 2023 to address this adverse event.During the surgery it was noticed that the cement had not adhered to the gii non-mod cem c/r fem sz5 lt, as it could be lifted from the femur bone with the bare hand.Patients' current health status is reported as good.

• Brand Name: GII NON-MOD CEM C/R FEM SZ5 LT
• Common Device Name: 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: 17262250
• Report Number: 1020279-2023-01409
• Device Sequence Number: 5910767
• Product Code: JWH
• UDI-Device Identifier: 03596010205803
• UDI-Public: 3596010205803
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: K951987
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2015
• Device Explanted Year: 2023
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 08/22/2023

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?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: 71420072
• Device Lot Number: 15RM19551
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/20/2023
• Supplement Date Received by Manufacturer: 08/01/2023
• Initial Report FDA Received Date: 07/05/2023
• Supplement Report FDA Received Date: 08/22/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 57 YR
• Patient Sex: Male
• Patient Weight: 83 KG