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
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Medical device site infection (4845)
Date of Event	10/22/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Given the nature of the alleged incident, the device was not returned for evaluation; therefore, a device analysis could not be performed.The clinical/medical investigation concluded that, a review of the documents provided did give any insight into the root cause of the reported suspected infection.The provided documents did not confirm infection following the reported biopsy.Although requested, the operative and laboratory data were not provided for review.Based on the limited information provided a thorough medical assessment could not be performed.The patient impact beyond the reported biopsy could not be determined.Should additional information be provided, the clinical/medical investigation task will be reopened.At this time, we have no evidence to conclude that the product failed to meet any specifications at the time of manufacture.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, after a left tka surgery was performed on (b)(6) 2023, a sterile joint puncture was performed on (b)(6) 2024 due to a suspected infection on the left knee.The infection was diagnosed on (b)(6) 2024, and an open biopsy was performed on (b)(6) 2024.Finally, on (b)(6) 2024, the patient required a total revision surgery and long-term antibiotics to address the adverse event.The patient is still recovering.

• Brand Name: LGN POR CR HA FEM SZ 7 LT
• 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: 21434536
• Report Number: 1020279-2025-00314
• Device Sequence Number: 4541313
• Product Code: MBH
• UDI-Device Identifier: 00885556108550
• UDI-Public: 885556108550
• Combination Product (Y/N): N
• Initial Reporter Country: SW
• PMA/510(K) Number: K091543
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2023
• Device Explanted Year: 2024
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 02/21/2025

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: 71425207
• Device Lot Number: 20HHA0015
• 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: 02/06/2025
• Initial Report FDA Received Date: 02/21/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 09/06/2022
• 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: GNS II RESURF PAT 35MM: 71420578, 22LM17227; LGN CRHF INS JRNY LCK SZ7-8 10:71425355,21MM16432; PRS TIBIA BSPLT JRNY LCK SZ7 LT:71425327,22DM13409
• Outcome Attributed to Adverse Event: Required Intervention; Hospitalization
• Patient Age: 64 YR
• Patient Sex: Male
• Patient Weight: 104 KG