MAUDE Adverse Event Report: SMITH & NEPHEW, INC. LGN HK FEM ASSEMBLY SZ 7 LT; PROSTHESIS, KNEE, FEMOROTIBIAL, CONSTRAINED, CEMENTED, METAL/POLYMER

Model Number	71421377
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Anemia (1706)
Date of Event	08/04/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).
Event or Problem Description
It was reported that after the patient underwent a 2-stage revision surgery to address a deep infection, the patient suffered from post-operative bleeding anemia.The adverse event was treated with transfusion of 2 erythrocyte concentrates with no further complications.
Additional Manufacturer Narrative
Internal reference number: (b)(4).
Additional Manufacturer Narrative
H3, h6: the device was not available for evaluation.The pictures provided were reviewed and could not confirm the stated failure mode.The clinical/medical investigation concluded that, the root cause of the first revision (2-stage) was due to a deep infection with s.Epidermidis and related symptoms; however, the mechanism of contamination which led to the deep infection could not be definitively concluded.The post-op ¿bleeding anemia¿ and subsequent transfusion was most likely due to the surgical procedure itself and does not reflect a component mal-performance.The assessed patient impact was the pain, swelling, infection, synovitis, aspirate, 2-stage revision, antibiotic therapy, blood loss anemia, and prbc transfusion.Further patient impact could not be assessed.No further medical assessment can be rendered at this time.A review of the manufacturing records did not reveal a manufacturing abnormality that could have caused or contributed to the reported incident.A review of complaint history for the part number over the past 12 months and for the batch number based on historical data of the device did not reveal similar events for the listed device.A review of the risk management file revealed this failure mode was previously identified.A review of the ifu document for knee systems provides complete guidelines of indications, contraindications, warnings and precautions and possible adverse effects that may occur preoperative, during surgery or post operative.The anticipated risk level is still adequate.A review of the sterilization records revealed the batch was sterilized within normal parameters.A historical review concluded that there are no prior actions related to this product and event.At this time, we have no reason to suspect that the product failed to meet any product specifications at the time of manufacture.Some potential probable causes for this event could include but not limited to surgical procedure, surgical complication or patient medical history.The contribution of the device to the reported event could not be corroborated.Based on this investigation, the need for corrective action is not indicated.Without the return of the actual product involved, our investigation could not proceed.Should the device or 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 HK FEM ASSEMBLY SZ 7 LT
• Common Device Name: PROSTHESIS, KNEE, FEMOROTIBIAL, CONSTRAINED, CEMENTED, METAL/POLYMER
• 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: 13343730
• Report Number: 1020279-2022-00310
• Device Sequence Number: 3919307
• Product Code: KRO
• UDI-Device Identifier: 00885556414880
• UDI-Public: 00885556414880
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: K081111
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Device Explanted Year: 2021
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 05/24/2022

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?: Yes
• Operator of Device: Health Professional
• Device Model Number: 71421377
• Device Catalogue Number: 71421377
• Device Lot Number: 20GM14423
• 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: 01/06/2022
• Supplement Date Received by Manufacturer: 03/02/2022; 04/29/2022
• Initial Report FDA Received Date: 01/25/2022
• Supplement Report FDA Received Date: 03/02/2022; 05/24/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 08/13/2020
• 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: 71420578 / GNS II RESURF PAT 35MM; 71421385 / LEGION HK 11MM BOLT - SLEEVE; 71422167 / LGN HK DIS FEM WDG SZ7 10MM; 71423352 / LEGION HK GD MOTION ISRT 11MM SZ 4-5 LT; 71424051 / LGN PRESSFIT STEM 18MM X 160MM; 71424055 / LGN PRESSFIT STEM 22MM X 160MM
• Outcome Attributed to Adverse Event: Other
• Patient Age: 77 YR
• Patient Sex: Male