MAUDE Adverse Event Report: SMITH & NEPHEW, INC. LGN CR HIGH FLEX XLPE SZ 5-6 11MM; PROSTH, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONST, CEMENTED, POLY/METAL/POLY

Model Number	71453122
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	Hypersensitivity/Allergic reaction (1907)
Date of Event	01/01/1901
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that after surgery the patient apparently shows some allergic reaction to the system implanted.
Additional Manufacturer Narrative
It was reported that after surgery the patient apparently shows some allergic reaction to the system implanted.The affected legion cr oxinium femoral component, legion cr high flexion insert, genesis ii cmt tibial baseplate and genesis ii resurfacing patellar component, used in treatment, were not returned for evaluation.Therefore a product analysis could not be performed.Our investigation including a review of the manufacturing records for the listed batches did not reveal any deviation from the standard manufacturing processes.A review of the complaint history for the listed parts revealed no prior complaints for the listed failure mode with the same batch number.At this time, we have no reason to suspect that the products failed to meet any product specifications at the time of manufacture.A relationship, if any, between the devices and the reported incident could not be corroborated.A review of instructions for use revealed the alleged failure is previously identified in the possible adverse events.Probable causes could include but not limited to patient allergy or material in use.No medical documents were received for investigation.Although it has been communicated that the patient had a patch test performed determine the possibility of an allergic reaction to zirconium or titanium, no results were provided for review.Therefore no medical assessment can be performed at this time.Based on this investigation, the need for corrective action is not indicated.Without the return of the actual products involved and no patient medical records available, our investigation of this report is inconclusive.No further investigation is warranted for this complaint; however smith and nephew will continue to monitor for future complaints and investigate as necessary.Should the device or additional information be received, the complaint will be reopened.

• Brand Name: LGN CR HIGH FLEX XLPE SZ 5-6 11MM
• 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: 9211445
• Report Number: 1020279-2019-03679
• Device Sequence Number: 16930551
• Product Code: JWH
• UDI-Device Identifier: 00885556035139
• UDI-Public: 00885556035139
• 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: health professional,user faci
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 02/13/2020

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: 71453122
• Device Catalogue Number: 71453122
• Device Lot Number: 18MM08186
• Initial Date Received by Manufacturer: 09/19/2019
• Supplement Date Received by Manufacturer: 02/09/2020
• Initial Report FDA Received Date: 10/18/2019
• Supplement Report FDA Received Date: 02/13/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention