MAUDE Adverse Event Report: SMITH & NEPHEW, INC. LGN POR CR HA FEM SZ 7 LT; PROSTHESIS, KNEE, PATELLO/FEMOROTIBIAL, SEMI-CONSTRAINED, UNCEMENTED, POROUS, CO

Catalog Number 71425207

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

Patient Problems Arthralgia (2355); Implant Pain (4561)

Event Date 12/08/2023

Event Type  Injury  

Event Description

It was reported that, after a porous tka system had been performed on (b)(6) 2023, the patient experienced severe left knee pain.The patient required two (2) additional, unplanned days in the hospital and received treatment in the form of medication (morfine, midozolam).The issue has been resolved.

Manufacturer Narrative

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

Manufacturer Narrative

Additional information: h6 (component code, type of investigation, investigation findings, investigation conclusions).Results of investigation: 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 stated that patient-specific clinical documentation had not been provided; therefore, the definitive clinical root cause for the adverse event could not be determined.The case report forms provided were used for this investigation.According to the report, the patient was treated with morphine and midazolam.Post-operative pain is a known common occurrence, as part of the healing process in the immediate post-operative period.The impact to the patient was the reported left knee pain and the medications.Since it was reported that the adverse event was resolved, no further clinical/medical assessment is warranted at this time.Should any additional relevant medical information be provided, this case would be re-assessed.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 femoral component and tibial baseplate part numbers over the past 12 months and for their batch numbers based on historical data of the devices did not reveal similar events for the listed devices.A review of complaint history based on the historical data revealed a similar event for the insert's batch.A review of complaint history revealed similar events for the patella 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 temporary or permanent nerve damage can result in pain or numbness of the affected limb.This has been identified as a possible adverse effect.A review of the risk management file revealed this failure mode was previously identified.The anticipated risk level is still adequate.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 traumatic injury, joint tightness, patient condition or postoperative care.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.Corrected data: h6 (health effect - clinical code).

• Brand Name: LGN POR CR HA FEM SZ 7 LT
• 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: 18466290
• MDR Text Key: 332330403
• Report Number: 1020279-2024-00051
• Device Sequence Number: 1
• Product Code: MBH
• Combination Product (y/n): N
• Reporter Country Code: NL
• PMA/PMN Number: K091543
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 02/21/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/08/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 71425207
• Device Lot Number: 20HHA0015
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/16/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/06/2022
• 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 CR XLP INS SZ5-6 9MM(PN:71425346,LN:21LM04251); PRS OV PATELLA SZ 32MM(PN:74027432,LN:22BM19430); PRS TIB BSPLT SZ6 LT(PN:71425326,LN:22EM05861)
• Patient Outcome(s): Required Intervention; Hospitalization
• Patient Age: 63 YR
• Patient Sex: Male