MAUDE Adverse Event Report: SMITH & NEPHEW, INC. LGN OFFSET COUPLER 4MM; PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL

Model Number	71424225
Medical Device Problem Code	Delivered as Unsterile Product (1421)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/26/2021
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that, during set up for a tka surgery, the package of a lgn offset coupler 4mm was noticed to be damaged, compromising the sterility of the device.No significant surgical delay was reported, as a smith and nephew backup device was available.Neither patient injury nor other complications were reported.
Additional Manufacturer Narrative
Results of investigation: the associated device was not returned for evaluation.The images provided were reviewed and they confirm the package is damaged.A review of the manufacturing records did not reveal a manufacturing abnormality that could have caused or contributed to the reported incident.A complaint history review found related failures for the listed batch, however, a manufacturing deficiency was not detected.This failure mode will be monitored for future complaints for any necessary corrective actions.An historical review concluded that there are no prior actions related to this product and event.A review of the packaging sequence revealed that the package should be sealed and sterile.A review of the risk management file revealed this failure mode was previously identified.The anticipated risk level is still adequate.Damage during shipping, mishandling or excessive exposure to high temperature environmental/climatic condition could be probable causes of the reported event.The contribution of the device to the reported event was corroborated due to the compromise of sterility.At this time, we have no evidence to suspect that the product failed to meet any product specifications at the time of manufacture, therefore, based on this investigation, the need for corrective action is not indicated.Should the device or additional information be received, the complaint will be reopened.No further investigation is warranted for this complaint; however, we will continue to monitor for future complaints and investigate as necessary.We consider this investigation closed.
Additional Manufacturer Narrative
The associated device was not returned for evaluation.The images provided were reviewed and they confirm the package is damaged.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 complaint history for the part number over the past 24 months and for the batch number based on historical data of the device did not reveal similar events for the listed device.An historical review concluded that there are no prior actions related to this product and event.A review of the packaging sequence revealed that the package should be sealed and sterile.A review of the risk management file revealed this failure mode was previously identified.The anticipated risk level is still adequate.Damage during shipping, mishandling or excessive exposure to high temperature environmental/climatic condition could be probable causes of the reported event.The contribution of the device to the reported event was corroborated due to the compromise of sterility.At this time, we have no evidence to suspect that the product failed to meet any product specifications at the time of manufacture, therefore, based on this investigation, the need for corrective action is not indicated.Should the device or additional information be received, the complaint will be reopened.No further investigation is warranted for this complaint; however, we will continue to monitor for future complaints and investigate as necessary.We consider this investigation closed.

• Brand Name: LGN OFFSET COUPLER 4MM
• Common Device Name: PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks rd.; memphis TN 38116
• Manufacturer (Section G): SMITH & NEPHEW, INC.; 1450 brooks rd.; memphis TN 38116
• Manufacturer Contact: holly topping ; 7000 west william cannon drive; austin, TX 78735 ; 5123913905
• MDR Report Key: 11977576
• Report Number: 1020279-2021-05112
• Device Sequence Number: 19680268
• Product Code: JWH
• UDI-Device Identifier: 03596010547132
• UDI-Public: 03596010547132
• Combination Product (Y/N): N
• Initial Reporter Country: NL
• PMA/510(K) Number: K043440
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 05/24/2022

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: 71424225
• Device Catalogue Number: 71424225
• Device Lot Number: 20ESM0083
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/26/2021
• Supplement Date Received by Manufacturer: 02/24/2022; 05/03/2022
• Initial Report FDA Received Date: 06/10/2021
• Supplement Report FDA Received Date: 02/24/2022; 05/24/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 10/16/2020
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: A
• Patient Sequence Number: 1
• Patient Sex: Unknown