MAUDE Adverse Event Report: SMITH & NEPHEW, INC. GII HA POR TIBIAL SZ 4 RT; PROSTH, KNEE, PATE/FEMOROTIBIAL, SEMI-CONST, UNCEM, PORO, COAT, POLY/METAL/POLY

Catalog Number	71422066
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Injury (2348)
Date of Event	02/27/2019
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported a failure of the tibial component.No injuries reported.No more information available.
Additional Manufacturer Narrative
The associated complaint device was not returned.A clinical evaluation was conducted and only chart sticks were provided.Without the requested supporting clinical documents a thorough medical investigation cannot be rendered.Should information become available this complaint can 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.This included a review of sterilization documents which indicated that the product was sterilized according to sterilization release documentation.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.

• Brand Name: GII HA POR TIBIAL SZ 4 RT
• Common Device Name: PROSTH, KNEE, PATE/FEMOROTIBIAL, SEMI-CONST, UNCEM, PORO, COAT, POLY/METAL/POLY
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks road; memphis TN 38116
• MDR Report Key: 8438598
• Report Number: 1020279-2019-01137
• Device Sequence Number: 10832205
• Product Code: MBH
• UDI-Device Identifier: 03596010496355
• UDI-Public: 03596010496355
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K030612
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,health professional,u
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 06/20/2019

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: 71422066
• Device Lot Number: 10MM06282
• Initial Date Received by Manufacturer: 02/27/2019
• Supplement Date Received by Manufacturer: 02/27/2019
• Initial Report FDA Received Date: 03/20/2019
• Supplement Report FDA Received Date: 06/20/2019
• 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