MAUDE Adverse Event Report: SMITH & NEPHEW, INC. GII PATELLAR DEPTH STOP; PROSTH, KNEE, PATE/FEMOROTIBIAL, SEMI-CONST, UNCEM, PORO, COAT, POLY/METAL/POLY

Catalog Number 71440326

Device Problem Connection Problem (2900)

Patient Problem Injury (2348)

Event Date 03/13/2019

Event Type  Injury  

Event Description

It was reported that during surgery performing inlay patella reaming and the depth stop slipped.This caused over reaming of the patella.He was able to bone graft the defect and then cement the implant.The procedure was delayed by approximately 20 minutes to prepare and graft the defect.We need to wait to see if any issue occurred as the patient recuperates.

Manufacturer Narrative

The associated genesis ii patellar reamer shaft and genesis ii patellar depth stop were returned and evaluated.A visual inspection of the devices noted they showed signs of significant wear/use.A functional evaluation by our quality control group found that the gold button on the patellar depth stop is assembled incorrectly which may cause the device to malfunction.A review of the complaint history for the listed parts revealed no prior complaints for the listed failure mode with the same batch number.This issue was also evaluated by our internal quality hold process and was found to be isolated.Based on this investigation, the need for corrective action is not indicated.This device was manufactured nearly 15 years ago.No further investigation is warranted for this complaint; however smith and nephew will continue to monitor for future complaints and investigate as necessary.Should additional information be received, the complaint will be reopened.

Manufacturer Narrative

The associated genesis ii patellar depth stop and genesis ii patellar reamer shaft were not returned for evaluation.After repeated requests, smith and nephew has been unable to obtain the batch information.Smith and nephew has an outstanding request with the reporter for the related lot data.As device details were not made available, a review of device history record cannot be performed.However, part numbers were provided.As batch number was not provided a complaint history review could not be performed with any accuracy due lack of lot information.A relationship, if any, between the devices and the reported incident or adverse event could not be corroborated.Without the return of the actual product involved, our investigation of this report is inconclusive.No further investigation is warranted for this complaint; however, smith and nephew will continue to monitor for future complaints and investigate as necessary.Should the device or additional information be received, this complaint will be reopened and reevaluated.

• Brand Name: GII PATELLAR DEPTH STOP
• Type of Device: PROSTH, KNEE, PATE/FEMOROTIBIAL, SEMI-CONST, UNCEM, PORO, COAT, POLY/METAL/POLY
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks road; memphis TN 38116
• MDR Report Key: 8475971
• MDR Text Key: 140691212
• Report Number: 1020279-2019-01333
• Device Sequence Number: 1
• Product Code: MBH
• UDI-Device Identifier: 03596010215000
• UDI-Public: 03596010215000
• Combination Product (y/n): N
• PMA/PMN Number: K121393
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,u
• Type of Report: Initial,Followup,Followup
• Report Date: 09/23/2019

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
• Device Operator: Health Professional
• Device Expiration Date: 02/18/2015
• Device Catalogue Number: 71440326
• Device Lot Number: 05BM10913
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/30/2019
• Initial Date Manufacturer Received: 03/13/2019
• Initial Date FDA Received: 04/02/2019
• Supplement Dates Manufacturer Received: 03/13/2019; 03/13/2019
• Supplement Dates FDA Received: 04/23/2019; 09/23/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention