MAUDE Adverse Event Report: SMITH & NEPHEW, INC. LGN PS HIGH FLEX XLPE SZ 7-8 10MM; PROSTHESIS,KNEE,PATELLOFEMOROTIBIAL,SEMICONSTRAINED,CEMENTED,POLYMERMETALPOLYMER

Model Number	71453177
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Loss of Range of Motion (2032); Scar Tissue (2060); Synovitis (2094)
Date of Event	11/04/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).
Event or Problem Description
It was reported that, after tkr surgery had been performed on (b)(6) 2019, the patient experienced a range of motion decreased from 30degree - to 80 degrees.This adverse event was solved by tkr revision surgery on (b)(6) 2021.Current health status of patient.Current health status is unknown.
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, per case details, approximately 2 years post tka, the patient required an insert revision/exchange (from 10mm to 9mm) with a radical open synovectomy due to recurrent limited range of motion secondary to ¿significant scar tissue¿.Reportedly, the patient had a significant history with a prior mua and arthroscopic synovectomy prior to a bowel cancer diagnosis.As of the date of this medical investigation, the requested clinical documentation has not been provided.Without the requested information, the reported event could not be fully assessed.However, it was reported that the patient had "significant scar tissue".The patient impact beyond that which was reported cannot be determined.Reportedly, ¿there is not any indication that the condition persists after the last procedure¿.No further medical investigation could be rendered at this time.If information is later provided to the medical investigation team, the clinical/medical task may be reassessed.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 12 months and for the batch number based on historical data of the device did not reveal similar events.A review of the risk management file revealed this failure mode was previously identified.The anticipated risk level is still adequate.The instructions for use documents revealed this failure mode was previously identified.An 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 are not limited to alignment, fit/size of device used or patient condition.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 tkr surgery had been performed on 02-dec-2019 to treat osteoarthritis, the patient experienced a decreased range of motion on an unspecified date despite of being compliant with post-op protocols.A manipulation under anesthetic was performed on an unspecified date, but it was not successful and the patient continued to have a limited range of motion.After that, on an unspecified date, the physician performed an arthroscopic synovectomy and the range of motion returned.Later on, the patient was diagnosed with bowel cancer soon after, and the range of motion decreased from 30 degree to 80 degrees.On 04-nov-2021 the physician performed a radical open synovectomy to decrease the insert thickness from 10 mm to 9 mm.Intraoperatively, it was noticed significant scare tissue.There is not any indication that the condition persists after the last procedure.
Event or Problem Description
It was reported that, after tkr surgery had been performed on (b)(6) 2019 to treat osteoarthritis, the patient experienced a decreased range of motion on an unspecified date despite of being compliant with post-op protocols.A manipulation under anesthetic was performed on an unspecified date, but it was not successful and the patient continued to have a limited range of motion.After that, on an unspecified date, the physician performed an arthroscopic synovectomy and the range of motion returned.Later on, the patient was diagnosed with bowel cancer soon after, and the range of motion decreased from 30 degree to 80 degrees.On 04-nov-2021 the physician performed a radical open synovectomy to decrease the insert thickness from 10 mm to 9 mm.Intraoperatively, it was noticed significant scare tissue.There is not any indication that the condition persists after the last procedure.
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, per case details, approximately 2 years post tka, the patient required an insert revision/exchange (from 10mm to 9mm) with a radical open synovectomy due to recurrent limited range of motion secondary to ¿significant scar tissue¿.Reportedly, the patient had a significant history with a prior mua and arthroscopic synovectomy prior to a bowel cancer diagnosis.As of the date of this medical investigation, the requested clinical documentation has not been provided.Without the requested information, the reported event could not be fully assessed.However, it was reported that the patient had "significant scar tissue".The patient impact beyond that which was reported cannot be determined.Reportedly, ¿there is not any indication that the condition persists after the last procedure¿.No further medical investigation could be rendered at this time.If information is later provided to the medical investigation team, the clinical/medical task may be reassessed.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 12 months and for the batch number based on historical data of the device did not reveal similar events.A review of the risk management file revealed this failure mode was previously identified.The anticipated risk level is still adequate.The instructions for use documents revealed this failure mode was previously identified.An 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 are not limited to alignment, fit/size of device used or patient condition.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.¿.

• Brand Name: LGN PS HIGH FLEX XLPE SZ 7-8 10MM
• Common Device Name: PROSTHESIS,KNEE,PATELLOFEMOROTIBIAL,SEMICONSTRAINED,CEMENTED,POLYMERMETALPOLYMER
• 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: 12857270
• Report Number: 1020279-2021-08313
• Device Sequence Number: 20079205
• Product Code: JWH
• UDI-Device Identifier: 00885556487143
• UDI-Public: 00885556487143
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K071071
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 03/01/2022

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: 71453177
• Device Catalogue Number: 71453177
• Device Lot Number: 19CM04678
• 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: 11/04/2021
• Supplement Date Received by Manufacturer: 02/25/2022; 02/25/2022
• Initial Report FDA Received Date: 11/22/2021
• Supplement Report FDA Received Date: 02/26/2022; 03/01/2022
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 03/06/2019
• 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: 71420172/GNS II CMT TIB SIZE 7 LEFT; 71420172/GNS II CMT TIB SIZE 7 LEFT; 71420628/GII LNG STEM 10MM X 100MM; 71420628/GII LNG STEM 10MM X 100MM; 71421017/GII OXIN P/S FEM LT SZ 7; 71421017/GII OXIN P/S FEM LT SZ 7
• Patient Sex: Unknown