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

Device Problem Wrong Label (4073)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 03/07/2024

Event Type  malfunction  

Event 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.

Manufacturer Narrative

Internal complaint reference number: (b)(4).

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.

• Brand Name: OXINIUM FEM HD 12/14 32MM +4
• Type of Device: 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
• MDR Text Key: 341293321
• Report Number: 1020279-2024-00834
• Device Sequence Number: 1
• Product Code: LZO
• Combination Product (y/n): N
• Reporter Country Code: AS
• PMA/PMN Number: K021673
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,User Facility,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 05/28/2024

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
• Device Operator: Health Professional
• Device Catalogue Number: 71343204
• Device Lot Number: 23FM03219
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 04/19/2024
• Initial Date FDA Received: 04/25/2024
• Supplement Dates Manufacturer Received: 05/24/2024
• Supplement Dates FDA Received: 05/28/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/06/2023
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1