MAUDE Adverse Event Report: SMITH & NEPHEW, INC. LGN REV TIBIA BASE SZ 4 RT; PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL

Catalog Number	71424014
Medical Device Problem Code	Connection Problem (2900)
Health Effect - Clinical Code	Joint Dislocation (2374)
Date of Event	02/16/2018
Type of Reportable Event	Serious Injury
Event or Problem Description
Patient had a legion revision done on friday (b)(6) and it dislocated on saturday (b)(6).All implants were removed on tuesday (b)(6) and replaced with a biomet 5 cm segmental knee.
Additional Manufacturer Narrative
The associated complaint device was not returned for evaluation.A clinical investigation concluded that no relevant documentation was provided to perform a medical investigation; therefore, no further medical assessment is warranted at this time.A review of the manufacturing records for the listed batch did not reveal any deviation from the standard manufacturing processes.Without the return of the actual product involved, our investigation of this report is inconclusive.No further actions are being taken at this time.Should additional information be received, the complaint will be reopened.We consider this investigation closed.

• Brand Name: LGN REV TIBIA BASE SZ 4 RT
• Common Device Name: PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks road; memphis TN 38116
• MDR Report Key: 7329712
• Report Number: 1020279-2018-00296
• Device Sequence Number: 11126088
• Product Code: JWH
• UDI-Device Identifier: 03596010546166
• UDI-Public: 03596010546166
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K043440
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Device Explanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 05/22/2018

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: No Information
• Device Catalogue Number: 71424014
• Device Lot Number: 16EM21461
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 02/17/2018
• Supplement Date Received by Manufacturer: 02/17/2018
• Initial Report FDA Received Date: 03/11/2018
• Supplement Report FDA Received Date: 05/22/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Weight: 136