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

Catalog Number	71440324
Medical Device Problem Code	Defective Component (2292)
Health Effect - Clinical Code	Injury (2348)
Date of Event	03/13/2019
Type of Reportable Event	Serious Injury
Event or Problem 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.
Additional 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.
Additional 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.

• Brand Name: GII PATELLAR REAMER SHAFT
• Common Device Name: 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: 8489942
• Report Number: 1020279-2019-01408
• Device Sequence Number: 1633619
• Product Code: MBH
• UDI-Device Identifier: 03596010214997
• UDI-Public: 03596010214997
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• PMA/510(K) Number: K121393
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,health professional,u
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 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
• Operator of Device: Health Professional
• Device Catalogue Number: 71440324
• Device Lot Number: 07BM14815
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/30/2019
• Initial Date Received by Manufacturer: 03/13/2019
• Supplement Date Received by Manufacturer: 03/13/2019; 03/13/2019
• Initial Report FDA Received Date: 04/07/2019
• Supplement Report FDA Received Date: 04/23/2019; 09/23/2019
• 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