MAUDE Adverse Event Report: SMITH & NEPHEW, INC. GII DISHED INS SZ 7-8 9MM; PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL

Catalog Number	71420790
Medical Device Problem Code	Material Deformation (2976)
Health Effect - Clinical Codes	Failure of Implant (1924); Aseptic loosening (4883)
Date of Event	11/06/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Internal complaint reference: (b)(6).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 conservatively submitting this report in accordance with applicable regulations.If additional information becomes available that alters the conclusions of this report, a follow-up report will be submitted as required.Note: a separated report under internal complaint reference case (b)(6) is being sent to cover the issue with the patellar implant.
Event or Problem Description
It was reported that, after tka surgery had been performed on (b)(6) 2017, the patient experienced the gns ii resurf pat 35mm patella component had loosened from the cement implant interface and the gii dished ins sz 7-8 9mm poly was slightly deformed on the anterior edge, but no significant signs of wear.This adverse event was solved by revision surgery on (b)(6) 2024, in which the gii dished ins sz 7-8 9mm and the gns ii resurf pat 35mm were explanted.Current health status of patient is unknown.No further complications were reported.
Additional Manufacturer Narrative
Additional information: d10, h6 (type of investigation and investigation findings), h10 (roi) h3, h6: given the nature of the alleged incident, the device could not be returned for evaluation.However, the photographs were reviewed and revealed that the dished insert is deformed.The clinical/medical investigation concluded that the provided electronic photocopied x-rays appear to support the complaint; however, do not provide further insight into the reported event.It is unknown what symptoms, if any, the patient experienced or if suffered any trauma to the knee prior to seeking medical attention.The reported patella loosening appears to have led to the revision; however, the clinical root cause of the ¿component has loosened from the cement implant interface¿ cannot be determined based on the limited information provided.It is unknown if the patient experienced trauma prior to the event; however, it is suspect as the reported ¿slight¿ deformation of the anterior edge of the insert could have also potentially resulted secondary to trauma, but this cannot be definitively concluded.The patient impact is determined to be the patellar component loosening along with ¿slight¿ deformation of the anterior edge of the insert resulting in revision of both patella and insert components.A transient restorative phase would be anticipated.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 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 and deformed prosthetic components.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 evidence to conclude that the product failed to meet any specifications at the time of manufacture.Factors that could contribute to the reported event include friction or joint tightness.Based on this investigation, the need for corrective action is not indicated.Should 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 DISHED INS SZ 7-8 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 ; 7000 west william cannon drive; austin, TX 78735 ; 5123913905
• MDR Report Key: 20774289
• Report Number: 1020279-2024-02472
• Device Sequence Number: 8088558
• Product Code: JWH
• UDI-Device Identifier: 03596010209443
• UDI-Public: 3596010209443
• 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 Implanted Year: 2017
• Device Explanted Year: 2024
• 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): 12/27/2024

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: 01/26/2026
• Device Catalogue Number: 71420790
• Device Lot Number: 16AM20034
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/06/2024
• Supplement Date Received by Manufacturer: 12/24/2024
• Initial Report FDA Received Date: 11/25/2024
• Supplement Report FDA Received Date: 12/27/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 01/29/2016
• 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
• Concomitant Medical Products and Therapy/Usage Dates: 71421228/LEGION CR OXIN FEM SZ8 RT.; 71931716/GII CMT GRV TIB BSPL SZ9 RT.; V0100013/VIS CUT GUIDE GII KIT RT.
• Outcome Attributed to Adverse Event: Other; Required Intervention
• Patient Sex: Unknown