MAUDE Adverse Event Report: SMITH & NEPHEW, INC. LGN PS HIGH FLEX XLPE SZ 5-6 10MM; PROST, KNEE, PATFEMTIB SEMI-CONSTRAINED, CEMENTED, POLY/MET/POLY

Model Number	71453175
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Loss of Range of Motion (2032); Insufficient Information (4580)
Date of Event	08/08/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Internal complaint reference: (b)(4).
Event or Problem Description
It was reported that a revision surgery of a left legion knee revision was scheduled for (b)(6) 2022.The reason for the revision surgery is unknown.No other information is available at this moment.
Event or Problem Description
It was reported that, after a left legion tka surgery was performed on an unknown date, the patient experienced stiffness.This adverse event was treated by a revision surgery on (b)(6) 2022, in which a legion ps xlpe size 5-6 9mm was exchanged and a debridement was also performed.Patient's current health status is unknown.
Additional Manufacturer Narrative
Additional information: d8, g4 (510k).Results of investigation: the device was not returned for evaluation and the reported event could not be confirmed.The clinical/medical investigation concluded that, as of the date of this medical investigation, the supporting clinical documentation has not been provided.Per the updated anz product complaint form, the revision consisted of a "poly change and debridement¿ implanting a lgn ps xlpe size 5-6 9mm to replace the explanted lgn ps xlpe size 5-6 10mm, reportedly due to stiffness.Further information and/or the device is not available per report.Therefore, no definitive clinical factors could be assessed which would have contributed to the event.With the limited information provided, the patient impact beyond the reported stiffness and subsequent revision cannot be determined.A review of complaint history for the previous 12 months did not reveal similar events for the listed device.A review of the instructions for use documents for knee systems revealed in possible adverse effects that decreased range of motion and unusual stress concentrations can result from trauma, improper implant selection, improper implant positioning, improper fixation, and/or migration of the components.Muscle and fibrous tissue laxity can also contribute to these conditions.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.Some potential probable causes could be alignment, traumatic injury, fit/size of the device used or migration of components.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.Corrected data: b5, d1, d4 (catalog number & udi number).

• Brand Name: LGN PS HIGH FLEX XLPE SZ 5-6 10MM
• Common Device Name: PROST, KNEE, PATFEMTIB SEMI-CONSTRAINED, CEMENTED, POLY/MET/POLY
• 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: 15307377
• Report Number: 1020279-2022-03851
• Device Sequence Number: 15026130
• Product Code: JWH
• UDI-Device Identifier: 00885556487044
• UDI-Public: 00885556487044
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K071071
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 09/29/2022

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: 71453175
• Device Catalogue Number: 71453175
• Device Lot Number: UNKNOWN
• 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: 08/08/2022
• Supplement Date Received by Manufacturer: 09/28/2022
• Initial Report FDA Received Date: 08/26/2022
• Supplement Report FDA Received Date: 09/30/2022
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown