MAUDE Adverse Event Report: SMITH & NEPHEW, INC. LGN PS HIGH FLEX XLPE SZ 3-4 11MM; PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL

Model Number	71420164
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	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
Additional Manufacturer Narrative
Internal complaint reference: (b)(4).
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
H3, h6: 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 revealed similar events for the listed device over the previous 12 months, but no similar events for the batch based on the historical data, this failure mode will be monitored for future complaints for any necessary corrective actions.A review of the risk management file revealed this failure mode was previously identified.The anticipated risk level is still adequate.A review of the instructions for use for this device reveal that improper fixation, and/or migration of the components could cause possible adverse effects.Also, the warnings and precautions section establish that the implant can become damaged as a result of strenuous activity or trauma.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.Factors and/or some potential probable causes that could contribute to the reported event have been identified as abnormal motion over time, bone degeneration, fit/sizing issue, lack of ingrowth, lifetime of device, and/or traumatic injury.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.
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).
Additional Manufacturer Narrative
Section h3, h6: the device was not returned for evaluation and the reported event could not be confirmed.The clinical/medical investigation concluded that, based on the documentation provided, the reported approximate 10-degrees of recurvatum of left knee with gross laxity and significant scar tissue were contributing factors to the chronic pain, mal-tracking patella and the multiple localized symptoms (tenderness, crepitus, sensations of grinding and instability).It is unknown to what extent the 10-degrees of recurvatum instability contributed to the patient¿s symptoms, however, it is a known, albeit less common, post-total knee arthroplasty complication.Although pre-revision imaging reportedly showed lucency and increased uptake, intra-op findings were ¿well-fixed¿ implants, otherwise.Without imaging, no assessment or comparison of the implant fixation is possible and a malperformance of the implants cannot be concluded.The assessed patient impact included the reported chronic pain, ¿failed knee with (gross) instability¿, scar tissue, laterally/maltracking patella and multiple localized symptoms.Further patient impact cannot be determined.No further medical assessment can be rendered at this time.A review of the production order did not reveal a manufacturing abnormality that could have caused or contributed to the reported incident.A review of complaint history revealed similar events for the listed device over the previous 24 months, but no similar events for the batch based on the historical data, 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 revealed that improper fixation, and/or migration of the components could cause possible adverse effects.Besides, the implant can become damaged as a result of strenuous activity or trauma.The patient should be warned of surgical risks, and made aware of possible adverse effects, this has been identified as warnings and precautions.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.Factors that could contribute to the reported event include gross laxity, significant scar tissue, abnormal motion over time, bone degeneration, size selected, lack of ingrowth, osteolysis and/or traumatic injury.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.B5: describe event or problem.D1: brand name.D4: catalog#, unique identifier (udi) #, expiration date , d11: concomitant medical products and therapy dates and h4: device manufacture date.H6: health effect - clinical code and health effect - impact code.G5: pma/510(k)#.
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 well the procedure and has started physical therapy three times a week.

• Brand Name: LGN PS HIGH FLEX XLPE SZ 3-4 11MM
• 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: 14176241
• Report Number: 1020279-2022-01900
• Device Sequence Number: 6291514
• Product Code: JWH
• UDI-Device Identifier: 00885556034170
• UDI-Public: 00885556034170
• Combination Product (Y/N): N
• Initial Reporter State: KS
• Initial Reporter Country: US
• PMA/510(K) Number: K071071
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Reporter Type: Manufacturer
• Report Source: Consumer
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 05/16/2023

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: 71420164
• Device Catalogue Number: 71453212
• Device Lot Number: 17KT93549
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/15/2020
• Supplement Date Received by Manufacturer: 05/12/2022; 08/12/2022; 05/10/2023
• Initial Report FDA Received Date: 04/21/2022
• Supplement Report FDA Received Date: 05/13/2022; 08/17/2022; 05/16/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 10/05/2017
• 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.; GNS II CMT TIB SIZE 3 LEFT, LOT#:H1711058.; LGN PS HIGH FLEX XLPE SZ 3-4 11MM-17KT93549.
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Age: 57 YR
• Patient Sex: Female