MAUDE Adverse Event Report: SMITH & NEPHEW, INC. LEGION PS OXIN FEM SZ6 LT; PROSTH, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONST, CEMENTED, POLY/METAL/POLY

Catalog Number	71421216
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	Pain (1994)
Date of Event	08/28/2019
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the patient was recovering well post surgery.Had a physiotherapy session where the knee was pushed down to increase the extension and from there the patient experienced pain.A revision surgery was performed due to this incident.
Additional Manufacturer Narrative
The associated devices were not returned.A clinical analysis indicated that without the requested clinical information a thorough medical investigation cannot be rendered.Should any additional medical information be provided this complaint will be re-assessed.A review of the manufacturing records did not reveal a manufacturing abnormality that could have caused or contributed to the reported incident.A review of complaint history on the listed part revealed no prior complaints for the listed batch with the same failure mode.Without the actual products involved and/or device information, our investigation cannot proceed.

• Brand Name: LEGION PS OXIN FEM SZ6 LT
• 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: 9363686
• Report Number: 1020279-2019-04144
• Device Sequence Number: 2167261
• Product Code: JWH
• UDI-Device Identifier: 00885556030059
• UDI-Public: 00885556030059
• Combination Product (Y/N): N
• Initial Reporter Country: SF
• PMA/510(K) Number: K043440
• 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): 11/24/2019

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: 71421216
• Device Lot Number: 18AM21925
• Initial Date Received by Manufacturer: 08/28/2019
• Supplement Date Received by Manufacturer: 08/28/2019
• Initial Report FDA Received Date: 11/22/2019
• Supplement Report FDA Received Date: 11/24/2019
• 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