MAUDE Adverse Event Report: SMITH & NEPHEW, INC. GNS II BICONVEX PAT 32MM; PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL

Catalog Number	71420572
Medical Device Problem Code	Device Dislodged or Dislocated (2923)
Health Effect - Clinical Code	Joint Dislocation (2374)
Date of Event	04/14/2018
Type of Reportable Event	Serious Injury
Event or Problem Description
Patient presented 4 years post tkr with patella implant broken off and lodged behind femoral prosthesis between posterior condyles.Revision surgery required to remove broken/loose patella, and tibial insert may need to be removed (exchanged) to facilitate removal.
Additional Manufacturer Narrative
The associated complaint device was not returned.The clinical/medical team concluded, based on the x-rays provided, the root cause of the "broken/loose patella" cannot be concluded.We did not receive the revision operative report nor and follow-up patient information.A review of the production documentation for the corresponding products did not reveal any deviation from the standard manufacturing processes.A review of complaint history for the listed part revealed no prior complaint for the listed batch.Without the actual product involved, our investigation cannot proceed.If the device or new information is received in the future, this complaint can be re-opened.We consider this investigation closed.

• Brand Name: GNS II BICONVEX PAT 32MM
• 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: 7489385
• Report Number: 1020279-2018-00866
• Device Sequence Number: 145094
• Product Code: JWH
• UDI-Device Identifier: 03596010208286
• UDI-Public: 03596010208286
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K951987
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 08/17/2018

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: Lay User/Patient
• Device Catalogue Number: 71420572
• Device Lot Number: 13GM21358
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 04/14/2018
• Supplement Date Received by Manufacturer: 04/14/2018
• Initial Report FDA Received Date: 05/05/2018
• Supplement Report FDA Received Date: 08/17/2018
• 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