MAUDE Adverse Event Report: SMITH & NEPHEW, INC. GNS II CON INS SZ7-8 18MM; PRSTHSS, KNEE, PTLLFMRTBIAL, SM-CNSTRND, CMNTD, POLYMER/METAL/POLYMER

Catalog Number	71420558
Medical Device Problem Code	Loose or Intermittent Connection (1371)
Health Effect - Clinical Code	Fibrosis (3167)
Date of Event	03/06/2018
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that revision surgery was performed due to severe arthrofibrosis, limitation of motion, failure of anterior locking component of the tibial insert.
Additional Manufacturer Narrative
The associated complaint device was not returned.The clinical/medical team concluded, based on the information provided, the only product failure, noted in the long list of unfortunate events, was for the 2nd revision on (b)(6) 2018.The procedure notes documented ¿mechanical complications of device with failure of fixation mechanism ¿ arthrofibrosis with severe range of motion limitation ¿ failure of the anterior locking component of the tibial poly insert and tibial base plate.The root cause of this failure cannot be concluded, however the documented arthrofibrosis cannot be excluded as a contributing factor.No current or updated information regarding the patient¿s current status has been provided at this time.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 complaints 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 CON INS SZ7-8 18MM
• Common Device Name: PRSTHSS, KNEE, PTLLFMRTBIAL, SM-CNSTRND, CMNTD, POLYMER/METAL/POLYMER
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks road; memphis TN 38116
• MDR Report Key: 7929016
• Report Number: 1020279-2018-02023
• Device Sequence Number: 19316846
• Product Code: JWH
• UDI-Device Identifier: 03596010208217
• UDI-Public: 03596010208217
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K951987
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Device Explanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 12/04/2018

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: 71420558
• Device Lot Number: 15JM10602
• Initial Date Received by Manufacturer: 09/05/2018
• Supplement Date Received by Manufacturer: 09/05/2018
• Initial Report FDA Received Date: 10/02/2018
• Supplement Report FDA Received Date: 12/04/2018
• 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