MAUDE Adverse Event Report: SMITH & NEPHEW, INC. GEN II 7.5MM RESUR PAT 32MM; PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL

Catalog Number	71932636
Medical Device Problem Code	Migration (4003)
Health Effect - Clinical Code	Osteolysis (2377)
Date of Event	12/19/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
H3, h6: the devices were not returned for evaluation; therefore, a device analysis could not be performed.The clinical/medical investigation concluded that the provided images confirm the reported osteolysis and patellar collapse.Based on the limited information provided, the clinical root cause for the osteolysis cannot be confirmed.The patient¿s age cannot be ruled out as a possible contributing factor to the reported osteolysis.The patellar collapse can be a result of osteolysis; however, this cannot be confirmed with the information provided.Devices batch numbers were 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 devices.A review of the instructions for use documents for knee systems revealed in possible adverse effects that, with all joint replacements, asymptomatic, localized, progressive bone resorption (osteolysis) may occur around the prosthetic components as a consequence of foreign-body reaction to particulate wear debris.Particles are generated by interaction between components, as well as between the components and bone, primarily through wear mechanisms of adhesion, abrasion, and fatigue.Secondarily, particles may also be generated by third-body wear.Osteolysis can lead to future complications necessitating the removal and replacement of prosthetic components.A review of the risk management files revealed this failure mode was previously identified.The anticipated risk levels are still adequate.A historical review concluded that there are no prior actions related to these products 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 abnormal loading of limb, alignment, patient anatomy/medical history, adverse reaction and/or bone quality.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.
Additional Manufacturer Narrative
Internal complaint reference: (b)(4).
Event or Problem Description
It was reported that, after the tka primary surgery had been performed on (b)(6) 2022, the patient experienced osteolysis, thinning, and collapse of the gen ii 7.5mm resur pat 32mm revealed by x-ray images.A revision surgery has been scheduled to exchange the patella component and the insert on (b)(6) 2026.Current health status of patient is unknown.
Additional Manufacturer Narrative
The devices were not returned for evaluation; therefore, a device analysis could not be performed.The clinical/medical investigation concluded that, the provided images confirm the reported osteolysis and patellar collapse.No further information is available.The clinical root cause for the osteolysis cannot be confirmed.The patient¿s age cannot be ruled out as a possible contributing factor to the reported osteolysis.The patellar collapse can be a result of osteolysis; however, this cannot be confirmed with the information provided.A review of the production orders did not reveal a manufacturing abnormality that could have caused or contributed to the reported incident.A review of complaint history for the part numbers over the past 12 months and for the batch numbers based on historical data of the devices did not reveal similar events for the listed devices.A review of the instructions for use documents for knee systems revealed in possible adverse effects that, with all joint replacements, asymptomatic, localized, progressive bone resorption (osteolysis) may occur around the prosthetic components as a consequence of foreign-body reaction to particulate wear debris.Particles are generated by interaction between components, as well as between the components and bone, primarily through wear mechanisms of adhesion, abrasion, and fatigue.Secondarily, particles may also be generated by third-body wear.Osteolysis can lead to future complications necessitating the removal and replacement of prosthetic components.A review of the risk management files revealed this failure mode was previously identified.The anticipated risk levels are still adequate.A historical review concluded that there are no prior actions related to this products 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 injury, patient medical history, adverse reaction and/or bone quality.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.
Additional Manufacturer Narrative
Internal complaint reference: (b)(4).

• Brand Name: GEN II 7.5MM RESUR PAT 32MM
• 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: 24132931
• Report Number: 1020279-2026-00085
• Device Sequence Number: 18728059
• Product Code: JWH
• UDI-Device Identifier: 00885556056721
• UDI-Public: 885556056721
• 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: 2022
• Device Explanted Year: 2026
• 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,Followup,Followup
• Report Date (Section B): 03/10/2026

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: 71932636
• Device Lot Number: 22GM11676
• 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: 12/24/2025
• Supplement Date Received by Manufacturer: 02/12/2026; 02/12/2026; 03/06/2026
• Initial Report FDA Received Date: 01/21/2026
• Supplement Report FDA Received Date: 02/13/2026; 02/26/2026; 03/10/2026
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 07/19/2022
• 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: PN: 74022126/ LN: 20AM12296; PN: 74022126/ LN: UNKNOWN
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Age: 84 YR
• Patient Sex: Male