MAUDE Adverse Event Report: SMITH & NEPHEW, INC. LEGION CR NP FEM SZ 4 RT; PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/LYMER

Model Number	71423214
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Anemia (1706); Constipation (3274)
Date of Event	11/28/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Internal complaint reference: (b)(4).
Event or Problem Description
It was reported that, after a tka surgery performed on (b)(6) 2022, the patient experienced constipation and post-operative anemia.The anemia was treated with 1 unit of rbc and the constipation with docusate sodium 50 mg + sennoside b 8 mg tablet.The patient recovered.
Additional Manufacturer Narrative
Given the nature of the alleged incident, the devices were not returned for evaluation but the reported event could be confirmed with the clinical/medical findings.The clinical/medical investigation concluded that, per complaint details, the study patient experienced constipation and post-operative anemia after a right cori-assisted total knee arthroplasty and was treated with docusate/sennoside b and 1 unit of red blood cell (rbc).The provided electronic case report forms (ecrfs) documented the anticipated, mild, and serious adverse event (ae)(#1) was unrelated to the study device but possibly related to the study procedure and required in-patient or prolonged hospitalization with start date as (b)(6) 2022.The ae summary/ecrf showed patient developed abdominal pain and imaging showed fecal loading throughout the colon/gas in rectum with bid docusate/sennoside started on (b)(6) 2022 per the medication ecrf.The pre-op hgb was 12 per operative data and the 1 unit of rbc was administered several days following the procedure ((b)(6) 2022).The patient outcome/ae(#1) was documented as recovered/resolved with an end date of (b)(6) 2022.Post-operative blood loss anemia and constipation are known possible risks with any surgical procedure and are not indicative of a malperformance of the component(s).The patient impact was the reported constipation with pain, post-op anemia, medication and blood product administration, and in-patient or prolonged hospitalization.No further medical assessment is warranted at this time.A review of the production orders for legion cruciate retaining nonporous femoral size 4 right, legion cruciate retaining high flexion cross linked polyethylene size, genesis ii non-porous tibial baseplate size 3 right and genesis ii oval resurfacing patellar 32mm 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 each device did not reveal similar events for the listed devices.A review of the instructions for use documents 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.Post-operative blood loss anemia and constipation are known possible risks with any surgical procedure and are not indicative of a malperformance of the component(s).A review of the risk management file is not applicable because no information was provided that relates the failure mode to the devices.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 patient condition and/or medical history.Based on this investigation, the need for corrective action is not indicated.Should the devices 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: LEGION CR NP FEM SZ 4 RT
• Common Device Name: PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/LYMER
• 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: 16400982
• Report Number: 1020279-2023-00365
• Device Sequence Number: 14854265
• Product Code: JWH
• UDI-Device Identifier: 00885556029930
• UDI-Public: 00885556029930
• Combination Product (Y/N): N
• Initial Reporter Country: NZ
• PMA/510(K) Number: K060742
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 04/12/2023

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 Model Number: 71423214
• Device Catalogue Number: 71423214
• Device Lot Number: 21HM06443
• 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: 01/24/2023
• Supplement Date Received by Manufacturer: 04/05/2023
• Initial Report FDA Received Date: 02/17/2023
• Supplement Report FDA Received Date: 04/12/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 08/09/2021
• 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: A
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: PN: 71420182 / LOT: 21GB00677.; PN: 71421032 / LOT: 21GB01791.; PN: 71453183 / LOT: 21JM20508.
• Outcome Attributed to Adverse Event: Required Intervention; Hospitalization
• Patient Sex: Female
• Patient Weight: 88 KG
• Patient Race: White