MAUDE Adverse Event Report: SMITH & NEPHEW, INC. GII OVAL PATELLA 5 PT. SZ GDE; PROSTHESIS, KNEE, FEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, METAL/POLYMER

Model Number 71440842

Device Problem Material Fragmentation (1261)

Patient Problem No Patient Involvement (2645)

Event Date 05/26/2020

Event Type  malfunction  

Manufacturer Narrative

Preliminary analysis of the product shows that it is broken, which is a reportable malfunction.

Event Description

It was initially reported that the genesis ii oval patella 5 pt.Size gde was found to be worn and torn from use.This was found during set up / inspection.No surgery or patient involvement.After evaluation by the manufacturing site, it was found that the device has a broken piece, which is considered a reportable malfunction.

Manufacturer Narrative

The device, intended for use in treatment, was returned for evaluation.A visual inspection was conducted and confirms one of the sizing guides is broken off.The broken piece was not returned with the device.A crack may have initiated during use or due to the heating and cooling associated with autoclaving.Plastics are vulnerable to brittle fractures due to over loading in a bending manner.The device was manufactured in 2011.This device shows significant signs of wear/usage.A review of complaint history on the listed part revealed no prior complaints for the listed batch with the same failure mode.A review of the manufacturing records did not reveal a manufacturing abnormality that could have caused or contributed to the reported incident.The device is a reusable instrument that can be exposed to numerous surgeries and cleaning cycles.As plastics are vulnerable and crack may have initiated during use and possible causes could be due to the heating and cooling associated with autoclaving or prolonged use.We recommend that all reusable instruments be routinely inspected for wear and damage and replaced as necessary.At this time, we have no reason to suspect that the product failed to meet any product specifications at the time of manufacture.Based on this investigation, the need for corrective action is not indicated.Should additional information be received, the complaint will be reopened.No further investigation warranted for this complaint; however we will continue to monitor for future complaints and investigate as necessary.We consider this investigation closed.

• Brand Name: GII OVAL PATELLA 5 PT. SZ GDE
• Type of Device: PROSTHESIS, KNEE, FEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, METAL/POLYMER
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks rd.; memphis TN 38116
• MDR Report Key: 10332157
• MDR Text Key: 200602828
• Report Number: 1020279-2020-03535
• Device Sequence Number: 1
• Product Code: HRY
• UDI-Device Identifier: 03596010485045
• UDI-Public: 03596010485045
• Combination Product (y/n): N
• PMA/PMN Number: K121393
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Type of Report: Initial,Followup
• Report Date: 09/21/2020

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 Model Number: 71440842
• Device Catalogue Number: 71440842
• Device Lot Number: 11FM09798
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/08/2020
• Initial Date Manufacturer Received: 07/06/2020
• Initial Date FDA Received: 07/28/2020
• Supplement Dates Manufacturer Received: 09/15/2020
• Supplement Dates FDA Received: 09/21/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1