MAUDE Adverse Event Report: SMITH & NEPHEW, INC. GII OVAL RESURFACING PAT 32MM; PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CMNTD, POLY/MTL/POLY

Catalog Number	71421032
Medical Device Problem Code	Loose or Intermittent Connection (1371)
Health Effect - Clinical Codes	Pain (1994); Injury (2348)
Date of Event	06/21/2016
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that a patient underwent a revision surgery on the left knee due to pain and stiffness.Properative films revealed a possible loosening of the patellar implant and significant heterotopic ossification, both were confirmed during revision.Only the patellar component was revised.
Additional Manufacturer Narrative
The associated complaint device was not returned.A clinical evaluation was conducted and based on the limited information provided, the root cause of the patient's reported pain and mua cannot be concluded; however, the loose patella was likely a contributing factor for the pain as well as the left tka revision.The impact to the patient beyond the expected pain from the revision procedure itself cannot be concluded.No further medical assessment is warranted at this time.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 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 OVAL RESURFACING PAT 32MM
• Common Device Name: PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CMNTD, POLY/MTL/POLY
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks road; memphis TN 38116
• MDR Report Key: 7555300
• Report Number: 1020279-2018-01018
• Device Sequence Number: 16473286
• Product Code: JWH
• UDI-Device Identifier: 03596010485069
• UDI-Public: 03596010485069
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K951987
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2014
• Device Explanted Year: 2016
• Reporter Type: Manufacturer
• Report Source: company representative,other
• Initial Reporter Occupation: Attorney
• Type of Report: Initial,Followup
• Report Date (Section B): 08/09/2018

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?: No
• Operator of Device: Health Professional
• Device Expiration Date: 06/16/2024
• Device Catalogue Number: 71421032
• Device Lot Number: 14FM13479
• Initial Date Received by Manufacturer: 05/29/2018
• Supplement Date Received by Manufacturer: 05/29/2018
• Initial Report FDA Received Date: 05/30/2018
• Supplement Report FDA Received Date: 08/09/2018
• 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
• Patient Age: 65 YR