MAUDE Adverse Event Report: SMITH & NEPHEW, INC. LGN PS HIGH FLEX XLPE SZ 3-4 9MM; PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL

Model Number	71420576
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Arthralgia (2355); Ambulation or Postural Difficulties (2544); Unequal Limb Length (4534); Swelling/ Edema (4577)
Date of Event	07/26/2021
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 replacement on the left knee had been performed on (b)(6) 2021, the patient never stopped having pain and swelling; difficulty walking and sitting for a long time; problems going up and down stairs, kneeling and remaining stood up for periods of one hour.The pain is constant and difficulting daily activities.The patient also walks with a limp as the right leg is shorter than the left.Patient has continued physical therapy, but there has not been any change and the knee is not improving.Patient also had manipulation under anesthesia at some point after the knee replacement.The situation is ongoing.The patient is bilateral: the right prosthetic knee was implanted on 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 no supporting medical documentation has been provided as there was reportedly no contact information provided.Based on the limited information provided, definitive contributing clinical factors could not be concluded.The current patient status is unknown.The patient impact beyond that which was reported cannot be determined.No further medical assessment is warranted 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 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 instructions for use documents for knee systems revealed that a decreased range of motion, pain and shortening of the leg has been identified in possible adverse events.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 traumatic injury, joint tightness, patient condition or postoperative care.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 replacement on the left knee had been performed on (b)(6) 2021 with a legion system, the patient never stopped having pain and swelling; difficulty walking and sitting for a long time; problems going up and down stairs, kneeling and remaining stood up for periods of one hour.The pain is constant and difficulting daily activities.The patient also walks with a limp as the right leg is shorter than the left.Patient has continued physical therapy, but there has not been any change and the knee is not improving.Patient also had manipulation under anesthesia at some point after the knee replacement.The situation is ongoing.The patient is bilateral: the right prosthetic knee was implanted on 2022.

• Brand Name: LGN PS HIGH FLEX XLPE SZ 3-4 9MM
• 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: 15591238
• Report Number: 1020279-2022-04397
• Device Sequence Number: 16694416
• Product Code: JWH
• UDI-Device Identifier: 00885556035252
• UDI-Public: 00885556035252
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K071071
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 11/07/2022

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?: No
• Operator of Device: Health Professional
• Device Model Number: 71420576
• Device Catalogue Number: 71453211
• Device Lot Number: 20CM14381
• 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: 09/19/2022
• Supplement Date Received by Manufacturer: 09/19/2022; 11/03/2022
• Initial Report FDA Received Date: 10/12/2022
• Supplement Report FDA Received Date: 10/19/2022; 11/07/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 03/17/2020
• 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: GNS II RESURF PAT 32MM (PART NUMBER: 71420576)
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown