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

Model Number	71421264
Medical Device Problem Codes	Adverse Event Without Identified Device or Use Problem (2993); Loosening of Implant Not Related to Bone-Ingrowth (4002)
Health Effect - Clinical Codes	Failure of Implant (1924); Pain (1994); Deformity/ Disfigurement (2360); Inadequate Pain Relief (2388); Ambulation or Postural Difficulties (2544); Subluxation (4525); Joint Laxity (4526); Implant Pain (4561)
Date of Event	12/17/2017
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that, after a total knee arthroplasty had been performed on (b)(6) 2017 using oxinim technology by smith & nephew, the patient has had pain and has been limping for over a year.It was noticed on a bone scan that the joint is loose as the cement did not stick and a revision surgery need to be performed, but it has not been scheduled as of today.
Additional Manufacturer Narrative
The affected complaint device, used in treatment, was not returned for evaluation.Therefore, a product analysis could not be performed.According to clinical/medical investigation, based on the review of the limited records provided, a definitive root cause for the patient¿s continued pain cannot be concluded.However, the surgeon indicated that he would diagnose loosening as the cause of her pain, although not to rule out infection.The device remains in-situ at this time.Therefore, this complaint can be reassessed if a revision occurs or if additional relevant supporting documentation becomes available.No further clinical assessment is warranted at this time.A review of the manufacturing records did not reveal any manufacturing or material abnormalities that could have caused or contributed to the reported incident.A review of complaint history for the listed part revealed no prior complaints for part, lot combination.There is no information that would suggest the device failed to meet specifications.A relationship, if any, between the device and the reported incident could not be corroborated.Based on this investigation, the need for corrective action is not indicated.Per the senior author, none of the complications were implant related and were as the article implied, procedure related.No further investigation is warranted for this complaint; however we will continue to monitor for future complaints and investigate as necessary.A review of risk management files and the instructions for use found that the reported failure was documented appropriately.Should the device or additional information be received, the complaint will be reopened.We consider this investigation closed.
Event or Problem Description
It was reported that, after a total knee arthroplasty had been performed on (b)(6) 2017 using oxinim technology by smith & nephew, the patient has had pain and has been limping for over a year.It was noticed on a bone scan that the joint is loose as the cement did not stick.Revision surgery will be performed on (b)(6) 2022.
Additional Manufacturer Narrative
H10: the device was not returned for evaluation and the reported event could not be confirmed.The clinical/medical investigation concluded that, based on the review of the limited records provided, a definitive root cause for the patient¿s continued pain cannot be concluded.However, the surgeon indicated that he would diagnose loosening as the cause of her pain, although not to rule out infection.The device remains in-situ at this time.Therefore, this complaint can be reassessed if a revision occurs or if additional relevant supporting documentation becomes available.No further clinical assessment is warranted 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 24 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.The anticipated risk level is still adequate.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.Possible causes could include but not limited to traumatic injury, joint tightness, material in use, patient reaction or loss of sterility.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.Internal complaint reference number: case-2020-00028621-1.
Event or Problem Description
It was reported that, after a total knee arthroplasty had been performed on (b)(6) 2017 using oxinium technology by smith & nephew, the patient has had pain and has been limping for over a year.It was noticed on a bone scan that the joint is loose as the cement did not stick.A revision surgery was conducted on (b)(6) 2022 to treat this adverse event.The intraoperative findings, diagnoses and the prosthesis explanted during this procedure remains unknown.The patient has started physical therapy for three times a week.
Additional Manufacturer Narrative
Corrected data: b4, h6 (health effect - impact code).
Event or Problem Description
It was reported that, after a total knee arthroplasty had been performed on (b)(6) 2017 using oxinium technology by smith & nephew, the patient has had pain and has been limping for over a year.It was noticed on a bone scan that the joint is loose as the cement did not stick.A revision surgery was conducted on (b)(6) 2022 to treat this adverse event.During this procedure, the articular insert was replaced with a 15 mm insert.Intraoperatively, a significant amount of scar tissue in the lateral gutter was removed and there was evidence of patellar maltracking.A lateral release was performed which did improve alignment.The femoral and tibial components were noted to be well fixed.The patient tolerated wee the procedure and has started physical therapy three times a week.
Additional Manufacturer Narrative
H11: further information received by the manufacturer has revealed that both the tibial and femoral knee components involved in the revision that took place on (b)(6) 2022 were found well fixed to the bone without evidence of loosening.Our investigation will be reassessed and its respective findings will be duly communicated through mdr report 1020279-2022-01900 (internal reference number (b)(4)).We consider all current investigations on mdr report 1020279-2020-07283 closed (internal reference number (b)(4)).

• Brand Name: LEGION NARROW PS OXIN SZ 4N LT
• 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: 10976883
• Report Number: 1020279-2020-07283
• Device Sequence Number: 19437856
• Product Code: JWH
• UDI-Device Identifier: 00885556233955
• UDI-Public: 00885556233955
• Combination Product (Y/N): N
• Initial Reporter State: KS
• Initial Reporter Country: US
• PMA/510(K) Number: K112941
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Consumer
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date (Section B): 03/23/2023

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?: Yes
• Operator of Device: Health Professional
• Device Model Number: 71421264
• Device Catalogue Number: UNKN01000000
• Device Lot Number: 17KM17886
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Received by Manufacturer: 11/11/2020
• Supplement Date Received by Manufacturer: 03/01/2021; 04/02/2022; 05/12/2022; 08/12/2022; 10/06/2022; 03/23/2023
• Initial Report FDA Received Date: 12/09/2020
• Supplement Report FDA Received Date: 03/03/2021; 04/21/2022; 05/13/2022; 08/17/2022; 10/07/2022; 03/23/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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: GII OVAL RESURFACING PAT 32MM-17KM02208; LGN PS HIGH FLEX XLPE SZ 3-4 11MM-17KT93549
• Outcome Attributed to Adverse Event: Other
• Patient Age: 57 YR
• Patient Sex: Female