MAUDE Adverse Event Report: SMITH & NEPHEW, INC. PRO METAPH TIB STEM 18MM; PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL

Catalog Number	71501010
Health Effect - Clinical Codes	Injury (2348); No Code Available (3191)
Date of Event	08/01/2018
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that a revision surgery for a product removal was performed.
Additional Manufacturer Narrative
The associated complaint device was not returned.A clinical evaluation was conducted and no clinically relevant documentation was provided, therefore, a thorough medical investigation could not be performed.The patient impact beyond the revision surgery and expected post-op convalescence period cannot be determined.No further medical assessment is warranted at this time.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: PRO METAPH TIB STEM 18MM
• 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: 7824702
• Report Number: 1020279-2018-01653
• Device Sequence Number: 1287033
• Product Code: JWH
• UDI-Device Identifier: 03596010218391
• UDI-Public: 03596010218391
• Combination Product (Y/N): N
• Initial Reporter Country: WZ
• PMA/510(K) Number: K933958
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Explanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 08/28/2018

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: 71501010
• Device Lot Number: ASKU
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 08/01/2018
• Supplement Date Received by Manufacturer: 08/01/2018
• Initial Report FDA Received Date: 08/28/2018
• Supplement Report FDA Received Date: 10/05/2018
• 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