MAUDE Adverse Event Report: SMITH & NEPHEW, INC. GNS II RESURF PAT 35MM; PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL

Catalog Number	71420578
Medical Device Problem Codes	Fracture (1260); Material Deformation (2976)
Health Effect - Clinical Codes	Discomfort (2330); Aseptic loosening (4883)
Date of Event	03/27/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Internal complaint reference: (b)(4).This complaint was opened by smith+nephew to document a reported patient complication that includes reference to the use of a smith+nephew product without evidence of a specific product problem.The reported complication relates to known inherent 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 confirm a relationship between the reported event and the device or 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.
Event or Problem Description
It was reported that, after a tka surgery was performed on (b)(6) 2020, the patient had a motorcycle accident.The patella's peg part broke off, causing a feeling of discomfort, and loosening of the patella.This adverse event was addressed by a revision surgery on (b)(6) 2025, in which the gns ii resurf pat 35mm and the jrny ii bcs xlpe art isrt sz 5-6 rt 9mm were replaced with new s+n implants.The current health status of the patient is unknown.
Additional Manufacturer Narrative
Internal complaint reference number: (b)(4).The device was returned and evaluated.The fields b1, d9, h3, h6 and h11 were updated.H3, h6: results of investigation: although the involvement of all the devices was reported, the relationship with the investigated failure was directly associated to the patella.The visual inspection revealed that the device returned significantly worn and discolored.The posts are deformed with significant material loss the surfaces are severely degraded.A lab analysis performed on the device revealed that the patellar component exhibited multiple signs of damage.Scratches were visible on both the anterior and posterior surfaces, while two of the three pegs were bent and showed partial shear.Bone cement was identified within the anterior cement cavity, and the peripheral region of the implant demonstrated material deformation along with surface damage.Device batch number was not provided, thus, an evaluation of the manufacturing records could not be performed.A review of complaint history for the previous 12 months did not reveal similar events for the listed device.A review of the instructions for use documents for knee systems revealed in warnings and precautions that the implant can break or become damaged as a result of strenuous activity or trauma.Additionally, patella fractures have been identified in possible adverse effects.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 to the material specification, the quality and manufacture of ultra-high-molecular-weight polyethylene (uhmwpe) as ram-extruded gur 1050 rod and compression-molded gur 1020 rod and plate shall be controlled.This material is used in the manufacture of surgical implants and instruments and can be considered a surgical grade of uhmwpe.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 excessive forces and/or traumatic injury.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.

• Brand Name: GNS II RESURF PAT 35MM
• 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: 21851519
• Report Number: 1020279-2025-00659
• Device Sequence Number: 15628168
• Product Code: JWH
• UDI-Device Identifier: 03596010208316
• UDI-Public: 3596010208316
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K951987
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• 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): 05/14/2026

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: 71420578
• Device Lot Number: UNKNOWN
• 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: 03/28/2025
• Supplement Date Received by Manufacturer: 05/12/2026
• Initial Report FDA Received Date: 04/16/2025
• Supplement Report FDA Received Date: 05/14/2026
• 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
• Concomitant Medical Products and Therapy/Usage Dates: JOURNEY TIBIA BASE NP RT SZ 6: 74022216, UNKNOWN; JRNY II BCS FEMORAL OXIN RT SZ8: 74022118, UNKNOWN; JRNY II BCS XLPE ISRT SZ 5-6 RT 9MM: 74027251, UNK
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Sex: Unknown