MAUDE Adverse Event Report: SMITH & NEPHEW, INC. GII TIBIAL BASE IMPACTOR; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, CEMENTED

Catalog Number 71440192

Device Problem Break (1069)

Patient Problem Device Embedded In Tissue or Plaque (3165)

Event Date 10/01/2019

Event Type  malfunction  

Event Description

It was reported that during surgery the bumper portion of impactor was flaking off into surgical incision.S&n backup was used.No delay to procedure, no injury to patient.

Manufacturer Narrative

It was reported that during surgery the bumper portion of impactor was flaking off into surgical incision.It is unknown if the flakes were removed.The associated femoral tibial implant impactor was not returned for evaluation.Therefore a product analysis could not be performed.However, our investigation noted the device failure in this complaint has been previously identified.Corrective actions have been implemented by the supplier in september of 2013 to prevent recurrence of this failure mode.The device in this complaint was manufactured prior to the implementation of those corrective actions.The tibial impactor bumper is made of acetal copolymer.A clinical analysis noted that acetal copolymer has good biocompatibility for limited contact (up to 24 hours), and non-clinical data from manufactures support prolonged contact (up to a month).Since no patient harm is being alleged and no further harm is anticipated, no further assessment is warranted at this time.The reported device was manufactured in 2004, which suggests it has been in use for some time.The impactor is a reusable device that can be exposed to numerous surgeries; damage from repeated use can occur.To avoid compromised performance or damage, it is recommended the device be inspected prior to/after each use and cleaning.Without the return of the actual product involved, our investigation of this report is inconclusive.No additional actions are being taken at this time; however we will continue to monitor for future complaints and investigate further as necessary.

• Brand Name: GII TIBIAL BASE IMPACTOR
• Type of Device: PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, CEMENTED
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks road; memphis TN 38116
• MDR Report Key: 9247967
• MDR Text Key: 164278166
• Report Number: 1020279-2019-03753
• Device Sequence Number: 1
• Product Code: JDI
• UDI-Device Identifier: 03596010214386
• UDI-Public: 03596010214386
• Combination Product (y/n): N
• PMA/PMN Number: K123598
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup
• Report Date: 12/02/2019

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
• Device Operator: Health Professional
• Device Expiration Date: 12/29/2014
• Device Catalogue Number: 71440192
• Device Lot Number: 04MM08201
• Initial Date Manufacturer Received: 10/01/2019
• Initial Date FDA Received: 10/28/2019
• Supplement Dates Manufacturer Received: 10/01/2019
• Supplement Dates FDA Received: 12/02/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1