MAUDE Adverse Event Report: SMITH AND NEPHEW, INC. GEN II CEMENTED TIBIAL B/PLATE SZ 2 LEFT; PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL

Catalog Number	71420162
Health Effect - Clinical Codes	Pain (1994); No Information (3190)
Date of Event	05/14/2018
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that revision surgery was performed.
Additional Manufacturer Narrative
The associated complaint devices were not returned.A clinical evaluation was conducted and based on the available information, the root causes for the ¿lateral instability of the left patella, or the subsequent full revision surgery cannot be concluded.There has been no cause or reason revealed or speculated in any of the documents provided except the osteophytes and the possibility of osgood-schlatter¿s disease.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 product involved and/or device information, our investigation cannot proceed.If the device or new information is received in the future, this complaint can be re-opened.No further actions are being taken at this time.We consider this investigation closed.
Event or Problem Description
It was reported that a revision surgery was performed.Several treatments were done such as analgesics and scan tests, which ended up in a revision surgery on (b)(6) 2018.Femoral, insert and tibial were removed.

• Brand Name: GEN II CEMENTED TIBIAL B/PLATE SZ 2 LEFT
• Common Device Name: PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL
• Manufacturer (Section D): SMITH AND NEPHEW, INC.; 1450 brooks road; memphis, tennessee; memphis 38116
• MDR Report Key: 7924190
• Report Number: 1020279-2018-02051
• Device Sequence Number: 1913924
• Product Code: JWH
• UDI-Device Identifier: 03596010206244
• UDI-Public: 03596010206244
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K951987
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2012
• Device Explanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: other
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 12/04/2018

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: Health Professional
• Device Catalogue Number: 71420162
• Device Lot Number: 12KM16721
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 09/05/2018
• Supplement Date Received by Manufacturer: 09/14/2018; 09/14/2018
• Initial Report FDA Received Date: 10/01/2018
• Supplement Report FDA Received Date: 10/03/2018; 12/04/2018
• 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