MAUDE Adverse Event Report: SMITH & NEPHEW, INC. LGN PS HIGH FLEX XLPE SZ 3-4 9MM; PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL

Model Number	71453211
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Hyperextension (4523); Subluxation (4525); Joint Laxity (4526)
Date of Event	03/27/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the patient underwent a second revision surgery of the right knee on (b)(6)2023 due to instability (hyperextension).During the procedure the 9mm insert and explanted and replaced with an 11mm insert.The patient kept experiencing instability even after this intervention.The primary right knee surgery was performed on (b)(6) 2022; and the first revision surgery of the knee was performed on (b)(6)2022 due to an infection (covered under case-(b)(4).
Additional Manufacturer Narrative
Internal complaint reference: case(b)(4).
Event or Problem Description
It was reported that the patient underwent a second revision surgery of the right knee on (b)(6) 2023 due to instability (hyperextension).During the procedure the 9mm insert and explanted and replaced with an 11mm insert.The patient kept experiencing instability even after this intervention.The primary right knee surgery was performed on (b)(6) 2022; and the first revision surgery of the knee was performed on (b)(6) 2022 due to an infection (covered under (b)(4)).
Additional Manufacturer Narrative
Section b5 and h6 were updated.Section h10: the explanted device was not returned for evaluation; therefore, a device analysis could not be performed.The clinical/medical investigation concluded that, although a date discrepancy is noted on the provided translated surgical report (¿dated (b)(6) 2023¿ vs ¿surgery dated: (b)(6) 2022¿), a second revision was performed due to instability/band insufficiency (believed to be approximately 9 months after the first revision) with the surgical indication: ¿¿ increasing hyperflexion had developed a few days ago with complex instability and a tendency to subluxate¿.¿clear mediodorsal instability and extensibility, with the integrity of the inner band still appearing intact¿ per the second revision note; therefore, the insert was changed to a condylar constrained and upsized to an 11mm insert (from 9mm) which provided ¿sufficient stable guidance of the knee joint with continued full extension and 140° flexion¿.The provided x-rays dated (b)(6) 2023 also appear non-congruent to the surgical report (dated 28-03-2023), as there are no obvious radiological signs of a recent surgical procedure.In conclusion, based on the revision surgical report, the mediodorsal instability/band insufficiency allowed for hyperflexion with a tendency to subluxate therefore leading to the second revision which included changing to a condylar constrained insert with an upsized thickness of 11mm (replacing the 9mm).The patient¿s extensive surgical history cannot be ruled out as a contributing factor to the reported event.Patient impact beyond that which was reported cannot be determined.No further medical assessment can be rendered at this time.Based on the information provided, the unsatisfactory experience could be confirmed.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 a similar event 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 in possible adverse effects that subluxation and unusual stress concentrations can result from trauma, improper implant selection, improper implant positioning, improper fixation, and/or migration of the components.Muscle and fibrous tissue laxity can also contribute to these conditions 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 specifications at the time of manufacture.Factors that could contribute to the reported event include size selected, joint laxity, patient condition or postoperative care.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.Internal complaint reference number: (b)(4).

• Brand Name: LGN PS HIGH FLEX XLPE SZ 3-4 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: 17163898
• Report Number: 1020279-2023-01340
• Device Sequence Number: 17585430
• Product Code: JWH
• UDI-Device Identifier: 00885556035252
• UDI-Public: 00885556035252
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: K071071
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• Device Explanted Year: 2023
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Consumer,Health Professional,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 08/01/2023

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?: No
• Operator of Device: Health Professional
• Device Model Number: 71453211
• Device Catalogue Number: 71453211
• Device Lot Number: 22BT60436
• 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: 06/06/2023
• Supplement Date Received by Manufacturer: 07/28/2023
• Initial Report FDA Received Date: 06/20/2023
• Supplement Report FDA Received Date: 08/01/2023
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 02/28/2022
• 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: 71420184/G2200777/LGN PS HIGH FLEX XLPE SZ 3-4 9MM.; 71420574/22AM14908/GNS II RESURF PAT 29MM.; 71423235/21GM17603/LEGION PS NP FEM SZ 5 RT.
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 31 YR
• Patient Sex: Female