MAUDE Adverse Event Report: SMITH & NEPHEW, INC. LGN XLPE PS INSERT SZ 1-2 9MM; PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL

Model Number	71453241
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Pain (1994); Loss of Range of Motion (2032)
Date of Event	11/17/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).
Event or Problem Description
It was reported that physician wants to take the lgn xlpe ps insert sz 1-2 9mm out since the knee has no range of motion.It is unknown if it has been solved or not.Patient outcome is unknown.
Additional Manufacturer Narrative
Internal complaint reference number: (b)(4).
Event or Problem Description
It was reported that physician wants to take the lgn xlpe ps insert sz 1-2 9mm out since the knee has no range of motion.Patient had to have blood drained and baker cyst removed after implantation.Patient is using splints and a cane to move.It also appear to have a walking limp.Patient is experiencing throbbing pain and its taking medication to help with this, but is not working.
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, physician desires to explant device due to patient experiencing, ¿no range of motion¿, cyst requiring drainage, and ¿using splints and a cane to move.¿ reportedly, patient ¿appears to have a walking limp,¿ and pain unrelieved by medication.The patient¿s current health status and all additional requested information was not provided.Without clinically relevant information for evaluation, the root cause of the reported symptoms cannot be definitively concluded.Further patient impact beyond the reported symptoms and events could not be assessed.No further medical assessment could be rendered at this time.A review of complaint history 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.The instructions for use documents revealed this failure mode was previously identified.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, overuse or excessive pressure on the joint, injury, infection and/or patient condition/reaction.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.

• Brand Name: LGN XLPE PS INSERT SZ 1-2 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: 12953777
• Report Number: 1020279-2021-08552
• Device Sequence Number: 19906460
• Product Code: JWH
• UDI-Device Identifier: 00885556255957
• UDI-Public: 00885556255957
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K071071
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Consumer,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 02/09/2022

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: 71453241
• Device Catalogue Number: 71453241
• 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: 11/17/2021
• Supplement Date Received by Manufacturer: 11/17/2021; 02/08/2022
• Initial Report FDA Received Date: 12/07/2021
• Supplement Report FDA Received Date: 12/30/2021; 02/09/2022
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Female