MAUDE Adverse Event Report: SMITH & NEPHEW, INC. LEGION NARROW PS OXIN SZ 4N RT; PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL

Catalog Number	71421274
Medical Device Problem Code	Biocompatibility (2886)
Health Effect - Clinical Codes	Erythema (1840); Inflammation (1932); Implant Pain (4561); Swelling/ Edema (4577)
Date of Event	01/10/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Internal complaint reference: (b)(4).
Event or Problem Description
It was reported that a patient had a right tka surgery performed on (b)(6) 2024, in which a s+n oxinium femur 4, a tibia 3 and a long non slotted stem of size 16x100 mm were implanted.The same day weight bearing, mobilization, stair case and commode training were achieved before discharge on pod5.A follow-up was scheduled 10 days post-operative, in which the patient's wound was inspected and found healthy, the patient was also pain free and mentioned that she has been doing some exercises.After 6 weeks of surgery, in the next follow-up the patient complaint of pain and swelling on the right knee.The patient was comfortable only for 1 month after the surgery.On examination it was noticed that there was local rise of temperature and redness of the right knee.After 3 months post-surgery the symptoms get better only when taking short coarse tapering doses of medrol, but as soon as she stops the medication, the symptoms reappear.All investigations-mr, infection markers, ct scans for malrotation are clear.The ige is raised as marker for allergies.Surgeon is potentially considering revision of the oxinium implants.
Additional Manufacturer Narrative
Additional information: d4 (catalog number, lot number, expiration date, unique identifier (udi) #), e1 (facility name and address), g4 (pma/510(k)number).
Event or Problem Description
It was reported that, after a right tka surgery had been performed on (b)(6) 2024, after the 6-week post-operative follow-up the patient complained of pain and swelling on the right knee.Patient reported being comfortable for 1 month after surgery.No history of fever was reported at the moment.On the examination during this follow-up, it was noticed a local rise of temperature and redness of the right knee.Patient was treated with tapering dose of medrol.After the 3-month follow-up the patient reported being symptomatically better by 50% while taking the medication, as soon as the medication is stopped the symptoms reappeared.Patient still complaint of pain, swelling and redness on her right knee.On examination, it was noticed a local rise of temperature and redness of the right knee.Range of motion was reported to 0-100 degrees.It was ruled out all the possible intrinsic and extrinsic causes of pain post tka (patellar maltracking, sepsis, obscure infection, deep vein thrombosis).Blood report showed that a raised ige was the only notable abnormality.Also, pet showed a synovial thickening that suggests a local inflammation.Healthwise, patient's current health status is ok.Surgeon is potentially considering revision of the oxinium implants.
Additional Manufacturer Narrative
H3, h6: the devices were not returned for evaluation; therefore, a device analysis could not be performed.The clinical/medical investigation concluded that, based on the documentation provided, the clinical root cause of the suspected reaction to zirconium could not be definitively concluded.However, consistent findings from provided chartstiks from all of the cases involved use of competitor biomaterial (bone cement), same surgeon, and facility, although smith and nephew implant choice selection/combinations vary.Therefore, an undiagnosed immunodeficiency or hypersensitivity and/or allergy to one of the materials in the cement and/or prosthetic components cannot be ruled out as a possible contributing factor.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 based on the historical data revealed similar events for the listed batch, this failure mode will be monitored for future complaints for any necessary corrective actions.A review of the instructions for use documents for knee system provides complete guidelines of indications, contraindications, warnings and precautions and possible adverse effects that may occur preoperative, during surgery or post operative.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 these 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 traumatic injury, patient condition, postoperative care, size selected or abnormal loading of limb.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 NARROW PS OXIN SZ 4N RT
• Common Device Name: PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL
• 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: 19393330
• Report Number: 1020279-2024-00998
• Device Sequence Number: 15396661
• Product Code: JWH
• UDI-Device Identifier: 00885556234150
• UDI-Public: 00885556234150
• Combination Product (Y/N): N
• Initial Reporter Country: IN
• PMA/510(K) Number: K112941
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted 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,Followup,Followup
• Report Date (Section B): 07/15/2024

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 Catalogue Number: 71421274
• Device Lot Number: 23GM06089
• 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: 05/02/2024
• Supplement Date Received by Manufacturer: 06/01/2024; 07/09/2024
• Initial Report FDA Received Date: 05/24/2024
• Supplement Report FDA Received Date: 06/17/2024; 07/15/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 07/13/2023
• 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: 71420182/23FB00770/GNS II CMT TIB SIZE 3 {} RIGHT; 71420578/22JB00983/GNS II RESURF PAT 35MM; 71420634/22GSM0185/GII LNG STEM 16MM X 100MM; 71453246/22HM13102/LGN XLPE PS INSERT SZ 3-4 9MM
• Patient Age: 77 YR
• Patient Sex: Female