MAUDE Adverse Event Report: SMITH & NEPHEW, INC. LGN POR CR HA FEM SZ 5 RT; PROSTHESIS, KNEE, PATELLO/FEMOROTIBIAL, SEMI-CONSTRAINED, UNCEMENTED, POROUS, CO

Catalog Number 71425215

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Loss of Range of Motion (2032)

Event Date 02/27/2024

Event Type  Injury  

Manufacturer Narrative

H10: internal complaint reference case (b)(4).

Event Description

It was reported that, after tka surgery had been performed on (b)(6) 2023, the patient experienced knee stiffness.This adverse event was solved by performing manipulation under anesthesia.Patient's current health status is recovered.No further complications were reported.

Manufacturer Narrative

Section h3, h6: given the nature of the alleged incident, the devices could not be returned for evaluation; therefore, a device analysis could not be performed.The clinical/medical investigation concluded that, per complaint details, the study patient experienced knee stiffness within 14 weeks of primary implantation.The case report form documented the mild severity adverse event onset date as (b)(6) 2024 as non-serious, not related to the study device but probably related to the procedure with a recovered/resolved outcome as of end date(b)(6) 2024 after concomitant procedure/surgery.The case report form show the patient mobilized post-op day 0 with 1 crutch as the primary ambulatory support at discharge and was prescribed post-op physical therapy/therapist-led home physical therapy.The case report form concomitant procedure sheet documented the procedure start and end date as (b)(6) 2024.Post-surgical adhesions/scar tissue and/or arthrofibrosis are known potential post-surgical complications and would not support a component malperformance.The impact to the patient beyond the reported knee stiffness and subsequent manipulation under anesthesia cannot not be determined based on 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.For the femoral component, a review of complaint history based on the historical data revealed similar events for the listed batch.For the patellar component and tibial baseplate, the review revealed similar events for the listed devices over the previous 12 months, but no similar events for the batches based on the historical data.For the insert, no similar events were revealed for the part number over the past 12 months nor for the batch number based on 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 decreased range of motion 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 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 this products and event.At this time, we have no evidence to conclude that the products failed to meet any specifications at the time of manufacture.Factors that could contribute to the reported event include alignment, size selected or wear.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.H6: health effect - impact code.

• Brand Name: LGN POR CR HA FEM SZ 5 RT
• Type of Device: 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: 18983947
• MDR Text Key: 338659929
• Report Number: 1020279-2024-00622
• Device Sequence Number: 1
• Product Code: MBH
• UDI-Device Identifier: 00885556108505
• UDI-Public: 00885556108505
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K091543
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 04/24/2024

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
• Device Operator: Health Professional
• Device Catalogue Number: 71425215
• Device Lot Number: 20LHA0031
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 03/26/2024
• Supplement Dates Manufacturer Received: 04/22/2024
• Supplement Dates FDA Received: 04/24/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/20/2022
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: LGN XLP INS SZ 3-4 9MM(PN:71425338,LN:21DM13440); PRS RND PAT SZ 32MM(PN:74025464,LN:22GM06622A); PRS TIB BSPT SZ3 RT(PN:71425303,LN:23GM04886)
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 69 YR
• Patient Sex: Female
• Patient Weight: 60 KG