MAUDE Adverse Event Report: SMITH & NEPHEW, INC. PRO CONF PL TB ISRT RT S2 10; PROSTHESIS, TOE, CONSTRAINED, POLYMER

Catalog Number 71508121

Device Problem Component or Accessory Incompatibility (2897)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 06/14/2018

Event Type  Injury  

Event Description

I was informed by dr (b)(6) to provide implants for the above case.Requested profix inserts.Intra-operatively we realized that the implants insitu was not a profix knee and was an advantum knee instead due to the profix insert not fitting properly.I advised the surgeon that this was the case but due to surgery in progress, he decided to still use the profix insert as the advantum one wasn't available.I advised the surgeon that the articulation will be affected and this was acknowledged.

Manufacturer Narrative

The associated complaint device was not returned for evaluation.A clinical evaluation noted that several attempts have been made to obtain clinical/medical documents to no avail.Without supporting clinical/medical documents a thorough investigation cannot be performed.Should information become available this complaint can be re-assessed.Our investigation including a review of the manufacturing records for the listed batch 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 failure mode with the same batch number.Without the return of the actual product involved, our investigation of this report is inconclusive.No further investigation is warranted for this complaint; however we will continue to monitor for future complaints and investigate as necessary.We consider this investigation closed.Should additional information be received, the complaint will be reopened.Credit cannot be issued for this device.

• Brand Name: PRO CONF PL TB ISRT RT S2 10
• Type of Device: PROSTHESIS, TOE, CONSTRAINED, POLYMER
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks road; memphis TN 38116
• Manufacturer (Section G): SMITH & NEPHEW, INC.; 1450 brooks road; memphis TN 38116
• Manufacturer Contact: sarah freestone ; 101 hessle road; hull hu3 2bn; UK
• MDR Report Key: 7653906
• MDR Text Key: 112840055
• Report Number: 1020279-2018-01251
• Device Sequence Number: 1
• Product Code: KWH
• UDI-Device Identifier: 03596010220653
• UDI-Public: 03596010220653
• Combination Product (y/n): N
• PMA/PMN Number: K946236
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 10/25/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/30/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Physician
• Device Catalogue Number: 71508121
• Device Lot Number: 10LM03501
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/14/2018
• Was Device Evaluated by Manufacturer?: No
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Congenital Anomaly