MAUDE Adverse Event Report: SMITH & NEPHEW, INC. LEGION NARROW PS OXIN SZ 6N RT; PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL

Model Number	71421276
Medical Device Problem Code	Manufacturing, Packaging or Shipping Problem (2975)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/18/2022
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that, during tka revision surgery, the legion narrow ps oxin sz 6n rt did not fit onto the bone.After the case, it was discovered that a journey ii femur was in the implant box.A smith and nephew backup device from another lot was used.Surgery was delayed 15 min as a consequence of this problem.The patient was not harmed.
Additional Manufacturer Narrative
Internal complaint reference: case(b)(4).Fab number/revision: (b)(4).
Additional Manufacturer Narrative
H3, h6: the associated device was returned and evaluated.A visual inspection of the returned device confirmed the stated failure mode.The device found in the packaging was not the correct product.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 manufacturing records did not reveal a manufacturing abnormality that could have caused or contributed to the reported incident.At this time, we do have reason to suspect that the product failed to meet any product specifications at the time of manufacture.A review of the risk management file revealed this failure mode was previously identified.The anticipated risk level is still adequate.According to production order and packaging sequence, the correct product should be in the package.Assessment of historical escalated cases concluded that there are no prior actions related to this device and failure mode.A contribution of the device to the reported event could be corroborated as the device and packaging did not match.The probable cause is a device mix-up.This issue is being evaluated through our internal process for any corrective actions.In addition, containment and preventive actions are being taken.Should additional information be received, the complaint will be reopened.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.
Additional Manufacturer Narrative
Section h3, h6: the associated device was returned and evaluated.A visual inspection of the returned device confirmed the stated failure mode.The device found in the packaging was not the correct product.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 manufacturing records did not reveal a manufacturing abnormality that could have caused or contributed to the reported incident.A review of the risk management file revealed this failure mode was previously identified.The anticipated risk level is still adequate.Assessment of historical escalated cases concluded that there are no prior actions related to this device and failure mode.At this time, we do have reason to suspect that the product failed to meet product specifications at the time of manufacture.According to production order and packaging sequence, the correct product should be in the package.A contribution of the device to the reported event could be corroborated as the device and packaging did not match.The potential probable cause for this event is likely a manufacturing process error caused by not following proper line clearance by batching multiple orders at the same workstation.As a result of the investigation, several process improvements are being implemented related to process monitoring and in process inspection.In addition, this event was addressed through a market removal of the product.Containment and remedial actions were performed for the impacted finished product.Should additional information be received, the complaint will be reopened.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: LEGION NARROW PS OXIN SZ 6N RT
• 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: 14149717
• Report Number: 1020279-2022-01869
• Device Sequence Number: 12211347
• Product Code: JWH
• UDI-Device Identifier: 00885556234259
• UDI-Public: 00885556234259
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K112941
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Physician
• Remedial Action: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 09/28/2022

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: 71421276
• Device Catalogue Number: 71421276
• Device Lot Number: 21JM17389
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/26/2022
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/04/2022
• Supplement Date Received by Manufacturer: 06/17/2022; 09/27/2022
• Initial Report FDA Received Date: 04/19/2022
• Supplement Report FDA Received Date: 06/20/2022; 09/29/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 09/27/2021
• 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
• Concomitant Medical Products and Therapy/Usage Dates: LEGION NARROW PS OXIN SZ 6N RT-21DM14774
• Patient Sex: Unknown