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

Model Number	71343212
Medical Device Problem Codes	Delivered as Unsterile Product (1421); Device Contaminated During Manufacture or Shipping (2969)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/05/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Internal complaint reference:(b)(4).
Event or Problem Description
It was reported that, during a thr surgery, when the customer opened the package during procedure, it was found that there was white powder on the oxinium fem hd 12/14 32 mm +12 and pouch.The surgery was completed, without any delay, with a smith and nephew back-up device.No injuries were reported.
Additional Manufacturer Narrative
H10: additional information in d9.H3, h6.The associated device was returned and evaluated.The visual inspection revealed some type of white substances inside the packaging and on the device.A review of the production order did not reveal a manufacturing abnormality that could have caused or contributed to the reported incident.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.According with inspection procedure, the visual inspection includes the verification of parts are clean and free of debris and contamination.Also, material specification shall control the quality and manufacture of the alloy wrought bar.A review made by the quality engineering team revealed that the potential factor that could contribute to the reported event is that the inner tray may had a fracture that was missed during final inspections.As the part was shipped out of smith and nephew controls, the fracture grew and eventually broke causing a sharp edge on the inner tray.This caused laceration of the plastic bag.The "white powder residue" that was found in the part was the remnants of the plastic bag as it was being lacerated.A meeting with packaging/operations was conducted to spread awareness of inspecting the inner tray for any small fractures.At this time, we do have reason to suspect that the product failed to meet specifications at the time of manufacture.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.H11: corrected information in h6 (medical device problem code).

• Brand Name: OXINIUM FEM HD 12/14 32 MM +12
• 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: 16854321
• Report Number: 1020279-2023-00949
• Device Sequence Number: 15146451
• Product Code: LZO
• UDI-Device Identifier: 03596010516275
• UDI-Public: 03596010516275
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K021673
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 06/21/2023

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: 71343212
• Device Catalogue Number: 71343212
• Device Lot Number: 18LM05997
• 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: 04/05/2023
• Supplement Date Received by Manufacturer: 06/19/2023
• Initial Report FDA Received Date: 05/02/2023
• Supplement Report FDA Received Date: 06/21/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 08/08/2018
• 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: A
• Patient Sequence Number: 1
• Patient Sex: Unknown