MAUDE Adverse Event Report: SMITH & NEPHEW, INC. OXINIUM FEM HD 12/14 28MM +4; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/CERAMIC/POLYMER, CEMENTED OR NON-POROUS

Model Number	71342804
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	06/08/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Internal complaint reference case-(b)(4).
Event or Problem Description
*us legal * it was reported that, after two revision surgeries, a third revision surgery was performed on (b)(6) 2021 due to unknown reasons, where the femoral head was removed and another from s-n was implanted instead.Patient outcome is unknown.
Event or Problem Description
It was reported that, after two revision surgery, the patient experienced left total hip recurrent instability.The issue was initially addressed with a left hip tha reduction under sedation and paralysis.However, the problem was not solved, and a third revision surgery was performed on 08- jun-2021 where the femoral head was removed and another from s-n was implanted instead.Patient outcome is unknown.
Additional Manufacturer Narrative
Internal reference number: (b)(4).
Additional Manufacturer Narrative
H3, h6; the device was not returned for evaluation and the reported event could not be confirmed.The clinical/medical investigation concluded that, per the surgical technique, the acetabular component is to be impacted with 15-20 degree of anteversion and 40-45 degree inclination angle.However, the surgeon noted in the revision operative note that the acetabular component was vertically placed.It is unknown if the reported vertical position of the acetabular cup led to the patient¿s pain, leg length discrepancy, and recurrent dislocations which eventually caused the recurrent instability and the subsequent revision.Based on the information provided, the clinical root cause of the reported clinical symptoms cannot be confirmed.It cannot be concluded that the reported clinical reactions are associated with a malperformance of the implant or implant failure.The patient impact beyond that which has already been reported cannot be determined.No further clinical assessment is warranted at this time.A review of the manufacturing records did not reveal a manufacturing abnormality that could have caused or contributed to the reported incident.A review of complaint history did not reveal similar events for the listed device.A review of the risk management file and instructions for use documents 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.At this time, we have no reason to suspect that the product failed to meet any product specifications at the time of manufacture.Possible causes could include but not limited to to procedural/user error, surgical complication or fit/sizing issue.The contribution of the device to the reported event could not be corroborated.Based on this investigation, the need for corrective action is not indicated.Without the return of the actual product involved, our investigation could not proceed.Should the device 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 28MM +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: 12953915
• Report Number: 1020279-2021-08554
• Device Sequence Number: 20041219
• Product Code: LZO
• UDI-Device Identifier: 03596010474162
• UDI-Public: 03596010474162
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K021673
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Device Explanted Year: 2021
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 02/23/2022

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?: No
• Operator of Device: Health Professional
• Device Model Number: 71342804
• Device Catalogue Number: 71342804
• Device Lot Number: 20AM21966
• 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: 11/16/2021
• Supplement Date Received by Manufacturer: 01/17/2022; 02/17/2022
• Initial Report FDA Received Date: 12/07/2021
• Supplement Report FDA Received Date: 01/28/2022; 02/23/2022
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 01/27/2020
• 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
• Outcome Attributed to Adverse Event: Other; Hospitalization
• Patient Age: 57 YR
• Patient Sex: Male