MAUDE Adverse Event Report: SMITH & NEPHEW, INC. GII C/R ART INS SZ 1-2 9MM; PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL

Catalog Number	71420480
Medical Device Problem Code	Material Erosion (1214)
Health Effect - Clinical Codes	Failure of Implant (1924); Subluxation (4525); Joint Impingement (4834)
Date of Event	04/01/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that, after tka surgery had been performed on an unknown date, the patient experienced an unspecified adverse event.This adverse event was solved by a revision surgery on (b)(6) 2025, in which it was found that the (1) gii c/r art ins sz 1-2 9mm was worn through completely on medial side.This resulted in the cocr femoral component articulating against the base plate.All implants were removed.Current patient's health status is unknown.
Additional Manufacturer Narrative
Internal complaint reference: (b)(4).This complaint was opened by smith+nephew to document a patient complication related to a product problem with a smith+nephew device.The reported issue(s) relate to known inherent device and/or procedural risks that are appropriately documented in our risk files.Smith+nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.Smith+nephew has no reason to suspect that the product failed to meet any specifications at the time of manufacture.Based on our review of all currently available information, we are unable to identify a definitive root cause.However, as the use of our product cannot be excluded as a potential cause or contributory factor to the reported issue, we are submitting this report in accordance with applicable regulations.If additional investigative findings or information becomes available that alters the conclusions of this report, a follow-up report will be submitted as required.
Additional Manufacturer Narrative
H3, h6: the devices were not returned for evaluation.However, the photographs were reviewed and revealed that the insert is extremely degraded with gouges.The tibial baseplate is also extremely degraded with scratches and gouges.Lastly, the femoral component shows signs of wear with scratches.The clinical/medical investigation concluded that the provided electronically photocopied pictures of explanted components appear to support the complaint of medial wear of the articulating insert as well as metallic component appearances consistent with the femoral component articulating directly against the left knee tibial baseplate, medially over a period of time.The discoloration of the articulating insert is also suggestive that the components had been in-vivo for some time.The knee systems instructions for use includes recommendations for long-term periodic follow-up to monitor position as well as bone and prosthetic component conditions and also cautions that patient should be warned that the device does not replace normal healthy bone and has a finite service life.The intraoperative finding of the articulating insert deformation/worn medially, along with photos supporting femoral articulation directly against the tibial baseplate is consistent with component-on-component impingement likely secondary to insert disassociation/subluxation due to trauma and/or joint laxity/ligament insufficiency, which can be a common finding after components have been in-vivo for years.However, a definitive clinical root cause cannot be concluded based on the photo images alone.The patient impact included the insert, tibial baseplate and femoral component deformation, medially, along with the subsequent revision.Although signs and symptoms were most likely present, no further information was provided, and the current patient status is unknown.A transient post-revision restoration phase would be anticipated.For the insert, 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 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.For the femoral component and the tibial baseplate, devices' specific identifiers were not provided.Therefore, an evaluation of the manufacturing records, complaint history review, risk management files and prior actions could not be performed.A review of the instructions for use documents for knee systems reveal in possible adverse effects that wear of the polyethylene articulating surfaces of knee replacement components has been reported following total knee replacement.Higher rates of wear may be initiated by particles of cement, metal, or other debris which can cause abrasion of the articulating surfaces.Higher rates of wear may shorten the useful life of the prosthesis, and lead to early revision surgery to replace the worn prosthetic components.At this time, we have no evidence to conclude that the products failed to meet any specifications at the time of manufacture.Based on this investigation, the need for corrective action is not indicated.Should the devices 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: h6 (health effect - clinical code).

• Brand Name: GII C/R ART INS SZ 1-2 9MM
• 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 ; 1450 brooks rd.; memphis, TN 38116 ; 5123913905
• MDR Report Key: 21884706
• Report Number: 1020279-2025-00682
• Device Sequence Number: 8146744
• Product Code: JWH
• UDI-Device Identifier: 03596010207845
• UDI-Public: 3596010207845
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K951987
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Explanted Year: 2025
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 06/13/2025

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 Expiration Date: 07/24/2023
• Device Catalogue Number: 71420480
• Device Lot Number: 13GT33199
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/01/2025
• Supplement Date Received by Manufacturer: 06/12/2025
• Initial Report FDA Received Date: 04/22/2025
• Supplement Report FDA Received Date: 06/13/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 07/24/2013
• 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 Sex: Unknown