MAUDE Adverse Event Report: SMITH & NEPHEW, INC. GNS II NON-POR TIB SZ 7 RIGHT; PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL

Model Number	71420190
Medical Device Problem Code	Loosening of Implant Not Related to Bone-Ingrowth (4002)
Health Effect - Clinical Codes	Pain (1994); Arthralgia (2355); Inadequate Osseointegration (2646); Joint Laxity (4526)
Date of Event	09/22/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Internal complaint reference: (b)(4).
Event or Problem Description
It was reported that, after a tka surgery had been performed on (b)(6) 2019, the patient experienced pain and the bia was loose.This adverse event was solved by a revision surgery on (b)(6) 2022.Current health status of patient is unknown.
Additional Manufacturer Narrative
The device was not returned for evaluation.The clinical medical team reviewed the single undated/unidentified ap x-ray image provided appears to show a right cemented tka with a reduced lateral tibia fracture inferior to the baseplate, however, no comparison images were provided.The clinical/medical investigation concluded that, based on the limited documentation provided, definitive clinical factors could not be concluded to have contributed to the reported event.The patient impact beyond the reported pain, ¿tibia loose¿, the noted lateral tibial fracture on x-ray and the revision could not be determined.No further medical assessment can be rendered at this time.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 revealed similar events for the listed device over the previous 12 months, but no similar events for the batch based on the historical data, 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 pain and looseness of components have been identified in possible adverse effects section.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 product specifications at the time of manufacture.Factors that could contribute to the reported event include abnormal motion over time, bone degeneration, size selected, inadequate integration between the cement and bone/implant, osteolysis, patient condition, postoperative care and/or traumatic injury.The contribution of the device to the reported event could not be corroborated.Based on this investigation, the need for corrective action is not indicated.Without the return of the actual product involved, our investigation could not proceed.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.
Event or Problem Description
It was reported that, after a tka surgery had been performed on (b)(6) 2019, the patient experienced pain and the tibia was loose.This adverse event was solved by a revision surgery on (b)(6) 2022.Current health status of patient is unknown.
Additional Manufacturer Narrative
Section h3, h6: the device was not returned for evaluation.The clinical medical team reviewed the x-ray image provided appears to show a right cemented tka with a reduced lateral tibia fracture inferior to the baseplate, however, no comparison images were provided.The clinical/medical investigation concluded that, based on the limited documentation provided, definitive clinical factors could not be concluded to have contributed to the reported event.The patient impact beyond the reported pain, ¿tibia loose¿, the noted lateral tibial fracture on x-ray and the revision could not be determined.No further medical assessment can be rendered at this time.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 revealed similar events for the listed device over the previous 12 months, but no similar events for the batch based on the historical data, 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 pain and looseness of components have been identified in possible adverse effects section.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 product specifications at the time of manufacture.Factors that could contribute to the reported event include abnormal motion over time, bone degeneration, size selected, inadequate integration between the cement and bone/implant, osteolysis, patient condition, postoperative care and/or traumatic injury.The contribution of the device to the reported event could not be corroborated.Based on this investigation, the need for corrective action is not indicated.Without the return of the actual product involved, our investigation could not proceed.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.B5: describe event or problem.

• Brand Name: GNS II NON-POR TIB SZ 7 RIGHT
• 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: 15626637
• Report Number: 1020279-2022-04454
• Device Sequence Number: 5979284
• Product Code: JWH
• UDI-Device Identifier: 03596010206374
• UDI-Public: 03596010206374
• Combination Product (Y/N): N
• Initial Reporter Country: NZ
• PMA/510(K) Number: K951987
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Device Explanted Year: 2022
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 11/29/2022

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: 08/01/2026
• Device Model Number: 71420190
• Device Catalogue Number: 71420190
• Device Lot Number: 16HM02438
• 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: 09/22/2022
• Supplement Date Received by Manufacturer: 09/22/2022; 11/25/2022
• Initial Report FDA Received Date: 10/18/2022
• Supplement Report FDA Received Date: 11/17/2022; 11/29/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 08/03/2016
• 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: LGN PS HIGH FLEX XLPE SZ 7-8 12MM, LOT#:16KM10492.
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Sex: Unknown