MAUDE Adverse Event Report: SMITH & NEPHEW, INC. GII OXIN P/S FEM LEFT SZ 5; PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL

Catalog Number	71421015
Medical Device Problem Code	Manufacturing, Packaging or Shipping Problem (2975)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/26/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Internal complaint reference number: (b)(4).S+n is conservatively reporting this event in association with a class ii recall pursuant to applicable regulations.
Event or Problem Description
It was reported that during tka surgery, while preparing to implant, the gii oxin p/s fem left sz 5 would not attach to the inserter.It was noticed that a size 5 right legion narrow ps femur had been packaged inside a genesis ii box.The procedure was completed without delay using a s+n back-up device.No injury was reported as a consequence of this issue.
Additional Manufacturer Narrative
H3, h6: the associated device was returned and evaluated.The visual inspection revealed that there was a legion narrow ps oxin sz 5n rt inside the package labeled gii oxin p/s fem left sz 5.A review of the production order did not reveal a manufacturing abnormality that could have caused or contributed to the reported incident.According with the packaging inspection procedure, the part number shall be checked.However, a review made by the quality engineering team revealed that the preliminary cause was a line clearance violation in which a different cleanroom operator processed multiple batches simultaneously.The root causes and contributing factors were defined as follows: there is no interconnectivity between the equipment in the work cell to prevent the operator from working on multiple orders at the same time, clear documentation for the importance of following these requirements with detail of potential patient impact has not been sufficiently implemented, the work cell allows for more than one order to be present, the action item description was not fully implemented per the defined plan, and only a portion of the action item (vision escalation process) was implemented, during implementation verification, the work instruction was verified to be released; however, the content of the revised work instruction was not verified against the action plan description, work standards and visual aids/management are not sufficient at the point of use.At this time, we do have evidence to conclude that the product failed to meet specifications at the time of manufacture.This issue was identified and is being addressed through quality process.Based on this investigation, the need for corrective action is indicated.Multiple action plans are being taken in regards to the root causes identified.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 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.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: GII OXIN P/S FEM LEFT SZ 5
• 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: 20446946
• Report Number: 1020279-2024-02101
• Device Sequence Number: 7045085
• Product Code: JWH
• UDI-Device Identifier: 03596010469212
• UDI-Public: 3596010469212
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K962557
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Company Representative
• Initial Reporter Occupation: Other
• Remedial Action: Recall
• Type of Report: Initial,Followup
• Report Date (Section B): 11/18/2024

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 Expiration Date: 11/06/2023
• Device Catalogue Number: 71421015
• Device Lot Number: 23LM02331
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/14/2024
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/02/2024
• Supplement Date Received by Manufacturer: 11/15/2024
• Initial Report FDA Received Date: 10/14/2024
• Supplement Report FDA Received Date: 11/18/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: A
• If action reported to FDA under 21 USC 360i(g), list FDA-assigned Recall Number or include a statement: Z-0281-2025
• Patient Sequence Number: 1
• Patient Sex: Unknown