MAUDE Adverse Event Report: SMITH & NEPHEW, INC. OXINIUM FEM HD 12/14 36 MM L/+8; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, CEMENTED

Model Number	71343608
Medical Device Problem Code	Connection Problem (2900)
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	04/20/2021
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that, after a recon surgery had been performed, x-ray appeared that the oxinium fem hd 12/14 36 mm l/+8 wasn¿t properly engaging the trunnion of the polarstem implant.The adverse event was addressed with a revision surgery to replace the head.The condition of the patient is unknown.
Additional Manufacturer Narrative
H6: the associated device, used in treatment, was returned and evaluated.A visual inspection of the returned device could not confirm the stated failure mode.The device has scratches along its flat face.A dimensional inspection could not confirm the stated failure mode.The device taper was found to be within specification.The clinical/medical evaluation concluded that based on the information provided, the clinical root cause could not be definitively concluded, although a user technique and/or variance could not be ruled out.The product evaluation could not render a definitive conclusion, but the dimensions were within tolerance.The surgical technique addresses reliable fit and restrictions on head/insert and head/taper combinations.The assessed patient impact was the disengaged femoral head and the same-day-revision procedure.Further patient impact could not be assessed.No further medical assessment could be rendered at this time.Should additional clinical documentation become available in the future, the clinical/medical task may be re-evaluated.A review of complaint history did not reveal additional complaints for the listed batch.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 not 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 and instructions for use documents revealed this failure mode and potential harm was previously identified.Some potential probable causes for this event could include a fit/ sizing issue or poor insertion technique.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.

• Brand Name: OXINIUM FEM HD 12/14 36 MM L/+8
• Common Device Name: PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, CEMENTED
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks rd.; memphis TN 38116
• MDR Report Key: 11809693
• Report Number: 1020279-2021-04032
• Device Sequence Number: 3832084
• Product Code: JDI
• UDI-Device Identifier: 03596010477293
• UDI-Public: 03596010477293
• Combination Product (Y/N): N
• Initial Reporter State: GA
• Initial Reporter Country: US
• PMA/510(K) Number: K022958
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 08/03/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: 71343608
• Device Catalogue Number: 71343608
• Device Lot Number: 20FM11468
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/30/2021
• Initial Date Received by Manufacturer: 04/20/2021
• Supplement Date Received by Manufacturer: 08/03/2021
• Initial Report FDA Received Date: 05/11/2021
• Supplement Report FDA Received Date: 08/03/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention