MAUDE Adverse Event Report: SMITH & NEPHEW, INC. GEN II CEMENTED TIBIAL B/PLATE SZ 7 LEFT; PROSTH, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONST, CEMENTED, POLY/METAL/POLY

Catalog Number	71420172
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Codes	Pain (1994); Injury (2348)
Date of Event	01/22/2019
Type of Reportable Event	Serious Injury
Event or Problem Description
A revision surgery was performed due to tibial component mal-aligned causing pain.Surgeon removed a size 7 left tibial baseplate and size 7-8 13mm pshf insert.Surgeon implanted a size 7-8 legion revision tibial baseplate with 2 each 5mm tibial step wedges and a size 7-8 15mm pshf insert.
Additional Manufacturer Narrative
The associated complaint devices were not returned.Without the actual devices involved and/or device information, our investigation cannot proceed.If the device or new information is received in the future, the complaints can be re-opened.The clinical / medical evaluation concluded that since no relevant clinical medical information was provided a thorough medical assessment could not be performed.No further actions are being taken at this time.We consider this investigation closed.

• Brand Name: GEN II CEMENTED TIBIAL B/PLATE SZ 7 LEFT
• 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: 8334169
• Report Number: 1020279-2019-00554
• Device Sequence Number: 11343249
• Product Code: JWH
• UDI-Device Identifier: 03596010206299
• UDI-Public: 03596010206299
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K951987
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Explanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 06/12/2019

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: 71420172
• Initial Date Received by Manufacturer: 01/22/2019
• Supplement Date Received by Manufacturer: 01/22/2019
• Initial Report FDA Received Date: 02/12/2019
• Supplement Report FDA Received Date: 06/12/2019
• 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
• Patient Age: 52 YR