MAUDE Adverse Event Report: SMITH & NEPHEW, INC. GNS II BICONVEX PAT 23MM; PROSTH, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONST, CEMENTED, POLY/METAL/POLY

Catalog Number	71420566
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Codes	No Consequences Or Impact To Patient (2199); Device Embedded In Tissue or Plaque (3165)
Date of Event	09/03/2019
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that after the implantation, a foreign particle was found, and it was picked up from the patient body.It was unknown if the particle was caused by the instruments or implants.
Additional Manufacturer Narrative
The associated complaint devices were not returned.The particle associated with this complaint was returned and evaluated.The material analysis concluded that the metallic particle was a titanium alloy, which is consistent with the material used to manufacture the tibial base.The origin of the particle could not be confirmed.A review of complaint history did not reveal additional complaints for the listed batches.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 devices involved our investigation cannot proceed.If the devices or new information is received in the future, the complaints can be re-opened.No further actions are being taken at this time.

• Brand Name: GNS II BICONVEX PAT 23MM
• 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: 9158544
• Report Number: 1020279-2019-03557
• Device Sequence Number: 16588452
• Product Code: JWH
• UDI-Device Identifier: 03596010208255
• UDI-Public: 03596010208255
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K951987
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,health professional,u
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 12/06/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: 71420566
• Device Lot Number: 19EM01705
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 09/04/2019
• Supplement Date Received by Manufacturer: 12/04/2019
• Initial Report FDA Received Date: 10/04/2019
• Supplement Report FDA Received Date: 12/06/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1