MAUDE Adverse Event Report: SMITH & NEPHEW, INC. OXINIUM FEM HD 12/14 32MM +4; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/CERAMIC/POLYMER, CEMENTED OR NON-POROUS

Catalog Number	71343204
Medical Device Problem Code	Wrong Label (4073)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/07/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that, during a thr surgery, upon opening the box labeled for one (1) oxinium fem hd 12/14 32mm +4, it was noticed that it contained an oxinium fem hd 12/14 36mm +4 instead.Both the packaging and the stickers inside indicated that the implant was an oxinium fem hd 12/14 32mm +4.The procedure was resumed without any delay, using an s+n back-up device.No injuries were reported as a consequence of this issue.
Additional Manufacturer Narrative
Internal complaint reference number: (b)(4).
Additional Manufacturer Narrative
H3, h6: the devices were not returned for evaluation; therefore, a device analysis could not be performed.However, the photographs were reviewed and revealed the label for oxinium fem hd 12/14 32mm +4, however the implant is an oxinium femoral head 12/14 taper 36 mm.According with the label specifications, all labels should include the correct part number, batch number and product name.A review of the production orders did not reveal a manufacturing abnormality that could have caused or contributed to the reported incident.However, a historical review concluded that a similar event was identified and it was determined that the root causes of this event were sharing of the vision system, unclear procedures around the vision system process and line clearance versus perceived order segregation.The following corrective actions are being taken: determine vision system capability needs and, based on those needs, determine how many machines need software upgrades, service agreements or replacement.Based on that determination, develop a proposal for capital expenditure and create a plan for implementation of these upgrades or replacements, from initial purchase to all vision systems operational, programmed and in production.As additional complaints were received for this failure mode, the event was re-evaluated by the quality engineering team.However, as there were previous escalated actions that still cover this issue, no further escalation was required.A review of complaint history for the part numbers over the past 12 months and for the batch numbers 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.At this time, we do have evidence to conclude that the product failed to meet specifications at the time of manufacture.Should the devices 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
H3, h6: the devices were not returned for evaluation.However, the photographs were reviewed and revealed the label for oxinium fem hd 12/14 32mm +4, but the implant is an oxinium femoral head 12/14 taper 36 mm.According with the label specifications, all labels should include the correct part number, batch number and product name.A review of the production orders did not reveal a manufacturing abnormality that could have caused or contributed to the reported incident.However, a historical review concluded that a similar event was identified and it was determined that the root causes of this event were sharing of the vision system, unclear procedures around the vision system process and line clearance versus perceived order segregation.As a part of the actions taken, the event was re-evaluated by the quality engineering team and other product families were reviewed for the implementation of preventive actions.The updated layout that was implemented as a part of the preventive action plans now has label printing, part vision inspection, and heat seal all within individual work cells.This encourages single piece flow through label print, part vision inspection and heat seal instead of batching.The following corrective actions are being implemented for the oxinium femoral heads product family: replace older implant inspection system model, create a workstation for the supervisor where they can complete day-to-day responsibilities while still having a more dedicated presence, remove or replace posted documents that are no longer legible or needed, labeling and cleanup where necessary and move the label printers into the work cell and perform print label in-cell.A review of complaint history for the part numbers over the past 12 months and for the batch numbers 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.At this time, we do have evidence to conclude that the product failed to meet specifications at the time of manufacture.Should the devices 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: OXINIUM FEM HD 12/14 32MM +4
• Common Device Name: PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/CERAMIC/POLYMER, CEMENTED OR NON-POROUS
• 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: 19187783
• Report Number: 1020279-2024-00834
• Device Sequence Number: 12549740
• Product Code: LZO
• UDI-Device Identifier: 03596010474223
• UDI-Public: 03596010474223
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K021673
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 08/12/2024

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 Catalogue Number: 71343204
• Device Lot Number: 23FM03219
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/19/2024
• Supplement Date Received by Manufacturer: 05/24/2024; 08/09/2024
• Initial Report FDA Received Date: 04/25/2024
• Supplement Report FDA Received Date: 05/28/2024; 08/12/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 06/06/2023
• 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
• Patient Sex: Unknown