MAUDE Adverse Event Report: SMITH & NEPHEW, INC. LGN PS HIGH FLEX XLPE SZ 1-2 9MM; PROSTH, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONST, CEMENTED, POLY/METAL/POLY

Model Number	71453201
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	Injury (2348)
Date of Event	10/07/2019
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the patient received total knee 4 years ago.A procedure was performed to remove what was thought to be a large bone spur.It was found to be large amounts of tissue damaged due to metastasis.Metastasis reported being because of poly dislocation.The surgeon decided to leave the metal components in place and perform a poly swap but the original size appeared loose during trialing larger size implanted.Original poly was kept by the facility.
Additional Manufacturer Narrative
The associated complaint device, used in treatment, was not returned for evaluation.A product analysis could not be performed.A relationship between the device and the reported event could not be corroborated.No material or manufacturing deviations could be observed in this investigation because no product batch information was provided.A device history review could not be performed because no batch information was provided.A complaint history review found related failures; this failure mode will be trended by post market surveillance to assess for any necessary corrective actions.Please refer to the instructions for use for recommendations on proper use of the device to prevent future reoccurrence of the reported event.The medical investigation concluded that the reported ¿metastasis¿ was likely meant to be ¿metallosis¿ based on ¿metastasis¿ reported being because of poly dislocation¿; however, this could not be definitively determined.The patient impact beyond the reported poly exchange (upsized) secondary to the reported poly dislocation and subsequent ¿metastasis¿ (believed to mean ¿metallosis¿) could not be concluded.No further medical assessment is warranted at this time.Should clinically relevant documentation be provided in the future, the clinical/medical task may be re-evaluated.Without the actual product involved and/ or product information, our investigation cannot proceed.If the device or new information is received in the future, the complaint can be re-opened.No further actions are being taken at this time.

• Brand Name: LGN PS HIGH FLEX XLPE SZ 1-2 9MM
• Common Device Name: PROSTH, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONST, CEMENTED, POLY/METAL/POLY
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks road; memphis TN 38116
• MDR Report Key: 9280064
• Report Number: 1020279-2019-03878
• Device Sequence Number: 2524369
• Product Code: JWH
• UDI-Device Identifier: 00885556033784
• UDI-Public: 00885556033784
• 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: company representative,health
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 01/20/2020

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: 71453201
• Device Catalogue Number: 71453201
• Device Lot Number: UNKNOWN/UNREADABLE
• Initial Date Received by Manufacturer: 10/07/2019
• Supplement Date Received by Manufacturer: 01/15/2020
• Initial Report FDA Received Date: 11/05/2019
• Supplement Report FDA Received Date: 01/20/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1