MAUDE Adverse Event Report: SMITH & NEPHEW, INC. LGN CR HIGH FLEX XLPE SZ 5-6 9MM; PROSTH, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONST, CEMENTED, POLY/METAL/POLY

Catalog Number	71453121
Medical Device Problem Code	Connection Problem (2900)
Health Effect - Clinical Code	Injury (2348)
Date of Event	07/30/2019
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that surgeon noticed fixed flexion of about 10-15 degs, patient apparently complaining that post and cam "clicking" on ambulation, possible mal rotation of femur/tibia prosthesis.Cr trial reduction performed intra operatively.Stability of the knee was achieved and that its the best option for the moment instead of doing a full femoral and tibial revision.Cr insert used (instead of ps).
Additional Manufacturer Narrative
The associated complaint device was not returned.A review of complaint history did not reveal additional complaints for the listed batch.A review of the manufacturing records did not reveal a manufacturing abnormality that could have caused or contributed to the reported incident.Without the actual device involved our investigation cannot proceed.If the device or new information is received in the future, the complaint can be re-opened.The medical investigation concluded that, based on the limited documentation provided, we are currently unable to rule out the reported possible malrotation of the primary implants as a contributing factor to the events.The patient impact beyond the insert revision itself could not be concluded given the current prosthetic combination.

• Brand Name: LGN CR HIGH FLEX XLPE SZ 5-6 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: 8920299
• Report Number: 1020279-2019-03116
• Device Sequence Number: 290372
• Product Code: JWH
• UDI-Device Identifier: 00885556033982
• UDI-Public: 00885556033982
• 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: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 11/18/2019

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 Catalogue Number: 71453121
• Device Lot Number: 19BM04606
• Initial Date Received by Manufacturer: 07/30/2019
• Supplement Date Received by Manufacturer: 11/12/2019
• Initial Report FDA Received Date: 08/22/2019
• Supplement Report FDA Received Date: 11/18/2019
• 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