MAUDE Adverse Event Report: SMITH & NEPHEW, INC. LGN CR HIGH FLEX XLPE SZ 3-4 11MM; PROSTH, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONST, CEMENTED, POLY/METAL/POLY

Model Number 71453112

Device Problem Unsealed Device Packaging (1444)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 06/07/2021

Event Type  malfunction  

Event Description

It was reported that, during knee surgery, it was found that a legion cr high flex xlpe size 3-4 11mm package was not sealed.This happened before use in patient.Surgery was performed (delay unknown) with a back-up device instead.Patient was not injured as consequence of this problem.

Manufacturer Narrative

H3, h6: the associated device, intended for use in treatment, was returned and evaluated.A visual inspection of the returned device confirmed the stated failure mode.The inner sterile pouch of the device packaging is unsealed at one end.A review of complaint history did not reveal additional complaints for the listed batch.A review of the manufacturing records did not reveal a manufacturing abnormality that could have caused or contributed to the reported incident.This issue has the same failure as the investigation started for capa-299 for contamination.The actions taken in capa-299 will address this issue; therefore, this nc investigation will be closed in reference to capa-299.At this time, we have reason to suspect that the product failed to meet product specifications at the time of manufacture.Some potential probable causes for this event could include packaging damage in transit or storage.Based on this investigation, the need for corrective action is indicated.Should additional information be received, the complaint will be reopened.This is an isolated event that is currently being monitored.No further investigation is warranted for this complaint; however, we will continue to monitor future complaints and investigate as necessary.We consider this investigation closed.

• Brand Name: LGN CR HIGH FLEX XLPE SZ 3-4 11MM
• Type of Device: PROSTH, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONST, CEMENTED, POLY/METAL/POLY
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks rd.; memphis TN 38116
• MDR Report Key: 12042918
• MDR Text Key: 257492943
• Report Number: 1020279-2021-05328
• Device Sequence Number: 1
• Product Code: JWH
• UDI-Device Identifier: 00885556034323
• UDI-Public: 00885556034323
• Combination Product (y/n): N
• PMA/PMN Number: K071071
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 10/22/2021

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: 71453112
• Device Catalogue Number: 71453112
• Device Lot Number: 20JM06814
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/22/2021
• Initial Date Manufacturer Received: 06/07/2021
• Initial Date FDA Received: 06/22/2021
• Supplement Dates Manufacturer Received: 10/21/2021
• Supplement Dates FDA Received: 10/22/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1