MAUDE Adverse Event Report: SMITH & NEPHEW, INC. LGN XLPE PS INSERT SZ 5-6 9MM; PROSTH, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONST, CEMENTED, POLY/METAL/POLY

Model Number	71453252
Medical Device Problem Code	Manufacturing, Packaging or Shipping Problem (2975)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/10/2021
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that when the box of the lgn xlpe ps insert sz 5-6 9mm was being opened, dr realized there appeared to be an opening in the package.Dr wanted to switch to a different poly to avoid potential contamination.Due to inventory constraints a different insert was used.Surgical delay of less than or equal to 30 minutes due this event.
Additional Manufacturer Narrative
The device, used in treatment, was not returned for evaluation.Therefore, product analysis could not be performed at this time.So the reported event could not be confirmed.A medical investigation was conducted and confirms per complaint details, during the procedure the surgeon ¿realized there appeared to be an opening in the package¿; therefore, a backup poly was requested to avoid potential contamination.However, ¿due to inventory constraints a different insert was used¿.Reportedly, there was a surgical delay of less than or equal to 30 minutes with no patient injury/harm due to the event.The requested medical documentation/information was not provided for inclusion in the medical investigation; therefore, the root cause of the reported event could not be fully assessed.Patient impact beyond the reported modified procedure/implantation of an alternate, unplanned insert could not be determined.No further medical assessment could be rendered at this time.Should clinically relevant information/documentation become available, the clinical/medical task may be re-opened for further evaluation.A review of complaint history for the listed parts revealed no prior 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.A review of risk management files and instructions for use found that the reported failure was documented appropriately.Some potential probable causes for this event could include packaging damage in transit or storage.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.Without the actual product involved and/or device information, our investigation cannot proceed.If the device or new information is received in the future, this complaint can be re-opened.No further actions are being taken at this time.We consider this investigation closed.

• Brand Name: LGN XLPE PS INSERT SZ 5-6 9MM
• 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: 11449987
• Report Number: 1020279-2021-01953
• Device Sequence Number: 11641135
• Product Code: JWH
• UDI-Device Identifier: 00885556255858
• UDI-Public: 00885556255858
• Combination Product (Y/N): N
• Initial Reporter State: CT
• Initial Reporter Country: US
• PMA/510(K) Number: K071071
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 04/29/2021

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 Model Number: 71453252
• Device Catalogue Number: 71453252
• Device Lot Number: 20FM14903
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 02/10/2021
• Supplement Date Received by Manufacturer: 04/09/2021
• Initial Report FDA Received Date: 03/10/2021
• Supplement Report FDA Received Date: 04/29/2021
• 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; Other; Required Intervention