MAUDE Adverse Event Report: SMITH & NEPHEW, INC. LGN REV TIBIA BASE SZ 3 LT; PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL

Model Number	71424003
Medical Device Problem Code	Inaccurate Information (4051)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/04/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that during tka, the surgeon selected a lgn rev tibia base sz 3 lt however, inside its external packing there was a package with a lgn rev tibia base sz 3 rt (71424013 lot: 18hm04753).When the internal package was opened it was verified that the implant had the description of the lgn rev tibia base sz 3 rt engraved and not the lgn rev tibia base sz 3 lt that was meant for use.A smith and nephew left tibial base size 4 was used to complete the surgery without significant delays.The patient was not harmed beyond the reported problem.
Additional Manufacturer Narrative
Internal complaint reference: (b)(4).
Additional Manufacturer Narrative
H3, h6: given the nature of the alleged incident, the device was not returned for evaluation, the pictures were reviewed, and could not confirm a product mix up.A review of the production order did not reveal a manufacturing abnormality that could have caused or contributed to the reported incident.This revealed that both products were created almost one year apart from each other, therefore, the product mix could not have occurred within smith & nephew's control of the identified batches.The clinical/medical investigation concluded that, based on the documentation provided, human error was a contributing factor; however, no clinical factors were identified which would have contributed to the reported event.The patient impact beyond the reported implantation of a larger-than-planned back-up tibial baseplate (sz 4 instead of the planned sz 3) and the reported 30 minute surgical extension could not be determined.It was documented on the complaint form that the patient was stable.No further medical assessment can be rendered at this time.A review of complaint history for the part number over the past 12 months and for the batch number based on historical data of the device did not reveal similar events for the listed device.A review of the label specification was performed and reveal that the external and internal package should include the same information for part number, lot number and part name.According to the sterile packaging inspection procedure it should be verify that laser etching of material and batch number on part matches material and batch on label and production order.A review of the risk management file revealed this failure mode was previously identified.The anticipated risk level is still adequate.A historical review concluded that there are no prior actions related to this product and event.At this time, we have no reason to suspect that the product failed to meet any product specifications at the time of manufacture.Factors that could contribute to the reported event include user error, mishandling or storage conditions.The contribution of the device to the reported event could not be corroborated.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 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 REV TIBIA BASE SZ 3 LT
• 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: 15104701
• Report Number: 1020279-2022-03471
• Device Sequence Number: 14766278
• Product Code: JWH
• UDI-Device Identifier: 03596010546074
• UDI-Public: 03596010546074
• Combination Product (Y/N): N
• Initial Reporter Country: CI
• PMA/510(K) Number: K043440
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 10/18/2022

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?: Yes
• Operator of Device: Health Professional
• Device Model Number: 71424003
• Device Catalogue Number: 71424003
• Device Lot Number: 17LM07832
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/04/2022
• Supplement Date Received by Manufacturer: 10/14/2022
• Initial Report FDA Received Date: 07/26/2022
• Supplement Report FDA Received Date: 10/18/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 11/10/2017
• 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: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown