MAUDE Adverse Event Report: SMITH & NEPHEW, INC. LGN POROUS CR FEM SZ 6L; PROSTHESIS, KNEE, PATELLO/FEMOROTIBIAL, SEMI-CONSTRAINED, UNCEMENTED, POROUS, CO

Catalog Number	71423246
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Bone Fracture(s) (1870); Damage to Ligament(s) (1952)
Date of Event	09/28/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that, during a clinical study, after a left tka surgery was performed on (b)(6)2023, the patient experienced a medial partial medical collateral ligament avulsion.This adverse event was solved with a small fragment screw.Health status of the patient is unknown.
Additional Manufacturer Narrative
Internal complaint number: (b)(4).
Additional Manufacturer Narrative
H3, h6: given the nature of the alleged incident, the devices were not returned for evaluation.The clinical/medical investigation concluded that, per complaint details, the porous total knee arthroplasty study patient required a small fragment screw fixation due to a left medial partial mcl (medial collateral ligament) avulsion.Reportedly, the avulsion occurred during the implantation procedure and was related to the use of trial size.Per the case report forms (crfs), the anticipated adverse event with a start date (implant date) of (b)(6) 2023 was documented as a serious adverse device event not related to the study device but possibly related to the study procedure with a recovering/resolving outcome after screw fixation.Reportedly, the trial size resulted in the ligament injury; however, limited details are provided in the crfs.The patient impact beyond that which was reported cannot be determined, although a post-operative restorative phase would be anticipated.The current patient status is unknown.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 that collateral ligament insufficiency is a contraindication for total knee replacement.Additionally, the possible adverse effects section revealed that 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 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 reason to suspect that the products failed to meet any specifications at the time of manufacture.Factors that could contribute to the reported event include procedural/user error, surgical complication or patient medical history.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.
Event or Problem Description
It was reported that, during a left tka surgery, the patient experienced a medial partial medical collateral ligament avulsion intraoperatively.This adverse event was solved with a small fragment screw.Patient is currently recovering.

• Brand Name: LGN POROUS CR FEM SZ 6L
• Common Device Name: PROSTHESIS, KNEE, PATELLO/FEMOROTIBIAL, SEMI-CONSTRAINED, UNCEMENTED, POROUS, CO
• 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: 18357872
• Report Number: 1020279-2023-02525
• Device Sequence Number: 17836519
• Product Code: MBH
• UDI-Device Identifier: 00885556032343
• UDI-Public: 00885556032343
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K073325
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2023
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 01/18/2024

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 Catalogue Number: 71423246
• Device Lot Number: 20JHA0010A
• 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: 11/27/2023
• Supplement Date Received by Manufacturer: 01/17/2024
• Initial Report FDA Received Date: 12/19/2023
• Supplement Report FDA Received Date: 01/18/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 08/17/2022
• 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: 71425324/22EM08447/POROUS TIBIA BSEPLATE W/JRNY LO; 71425344/21FM07060/LGN CRHF XLPE INS W/JRNY LCK SZ; 74025464/21DM17112/POROUS ROUND PATELLA SZ 32MM
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 73 YR
• Patient Sex: Female
• Patient Weight: 86 KG