MAUDE Adverse Event Report: SMITH & NEPHEW, INC. LGN REV TIBIA BASE SZ 4 LT; PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL

Model Number	71424004
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Joint Laxity (4526)
Date of Event	01/01/2009
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that, the patient underwent a left tka two-stage revision due to an unspecified infection as primary diagnosis.Approximately six (6) months after this procedure, the patient experienced instability in the revised knee and required a second revision.The dates in which the index surgery, first 2-stage revision and second revision took place are not known.It is also unknown which devices were explanted and/or exchanged during the second revision.This incident was identified in a retrospective post-market clinical follow up activity (pmcf) where anonymized data summarizing tka revision outcomes were gathered; therefore, additional information is not known.
Additional Manufacturer Narrative
Internal complaint reference: (b)(4).This complaint was opened by smith+nephew to document a patient complication identified through the review of clinical evidence from post market clinical data collection activities that includes reference to the use of a smith+nephew product.The reported issue(s) relate 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, the patient underwent a left tka two-stage revision due to an unspecified infection as primary diagnosis.Approximately six (6) months after this procedure, the patient experienced instability in the revised knee and required a second revision.It is unknown which devices were explanted and/or exchanged during the second revision.This incident was identified in a retrospective post-market clinical follow up activity (pmcf) where anonymized data summarizing tka revision outcomes were gathered; therefore, additional information is not known.
Additional Manufacturer Narrative
H3, h6: given the nature of the alleged incident, the devices could not be returned for evaluation.The clinical/medical investigation concluded that, as the date of this medical investigation the requested supporting documentation has not been provided.Without the patient specific documentation, no contributing clinical factors could be definitively concluded.The patient impact beyond the reported instability and subsequent revision cannot be determined.No further medical assessment could be rendered at this time.A review of the production orders did not reveal a manufacturing abnormality that could have caused or contributed to the reported incident.For the gns ii con ins sz3-4 21mm and legion scw lwdg s5 10d x 10p, a review of complaint history for the part number over the past 33 months and for the batch number based on historical data of the device did not reveal similar events for the listed device.For the rest of the devices, a review of complaint history revealed similar events for the listed part numbers over the previous 33 months, but no similar events for the batches 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 postoperative patient care and directions and warnings to patients by physicians are extremely important.Protected weight bearing with external support is recommended for a period of time to allow healing.Normal daily activity may be resumed at the physician¿s direction.Also, warnings and precautions states that the patient should be warned of surgical risks, and made aware of possible adverse effects.The patient should be warned that that the implant can become damaged as a result of strenuous activity or trauma.Besides, possible adverse effects section states that temporary or permanent nerve damage can result in pain or numbness of the affected limb.A review of the risk management files 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 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 size selected, joint laxity or patient condition.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: LGN REV TIBIA BASE SZ 4 LT
• 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: 16211220
• Report Number: 1020279-2023-00147
• Device Sequence Number: 19915289
• Product Code: JWH
• UDI-Device Identifier: 03596010546081
• UDI-Public: 03596010546081
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K043440
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Study,User Facility,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 11/20/2024

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?: No
• Operator of Device: Health Professional
• Device Expiration Date: 02/01/2019
• Device Model Number: 71424004
• Device Catalogue Number: 71424004
• Device Lot Number: 09BM02172
• 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: 01/19/2023
• Supplement Date Received by Manufacturer: 09/26/2024; 11/13/2024
• Initial Report FDA Received Date: 01/19/2023
• Supplement Report FDA Received Date: 09/27/2024; 11/20/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 02/03/2009
• 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: 71420532 / LOT: 02JM08712; PN: 71421664 / LOT: 08LM06917; PN: 71421744 / LOT: 07HM19736; PN: 71424031 / LOT: 07EAB0065A; PN: 71424043 / LOT: 08GAB0025C
• Outcome Attributed to Adverse Event: Required Intervention; Hospitalization
• Patient Age: 74 YR
• Patient Sex: Female
• Patient Weight: 81 KG