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
Medical Device Problem Code	Unsealed Device Packaging (1444)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/07/2021
Type of Reportable Event	Malfunction
Event or Problem 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.
Additional 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
• Common Device Name: 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
• Report Number: 1020279-2021-05328
• Device Sequence Number: 3323284
• Product Code: JWH
• UDI-Device Identifier: 00885556034323
• UDI-Public: 00885556034323
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K071071
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 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
• Operator of Device: 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 Received by Manufacturer: 06/07/2021
• Supplement Date Received by Manufacturer: 10/21/2021
• Initial Report FDA Received Date: 06/22/2021
• Supplement Report FDA Received Date: 10/22/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1