MAUDE Adverse Event Report: SMITH & NEPHEW, INC. OXINIUM FEM HD 12/14 32MM -3; PROSTHESIS,HIP,SEMICONSTRAINED METALCERAMICPOLYMER,CEMENTEDORNON-POROUS

Model Number	71343203
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Bone Fracture(s) (1870)
Date of Event	12/04/2021
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that, after a thr surgery performed with direct anterior approach on (b)(6) 2021, the surgeon identified on post op x-ray fracture of femur distal to tip of femoral implant.So, on (b)(6) 2021 a revision surgery was performed, surgeon chose to leave primary stem inside the patient and utilized cables to stabilize the fracture, but the oxonium femoral head 12/14 taper 32mm -3 was replaced through direct anterior approach.Current health status of the patient is unknown.
Additional Manufacturer Narrative
Internal complaint reference (b)(4).
Additional Manufacturer Narrative
H3, h6: the device was not returned for evaluation and the reported event could not be confirmed.The contribution of the device to the reported event could not be corroborated.The clinical/medical investigation concluded that, this case reports that after a thr, the surgeon identified a fracture of the femur distal to the tip of the femoral implant on a post-op x-ray.Three days later the patient had a revision.Per the complaint details, the surgeon opted to leave the stem in place, use cables to stabilize the fracture, and replace the femoral head.Per email communication, no additional information is available.Without clinically relevant information for evaluation, the root cause of the reported pain cannot be definitively concluded.Further patient impact beyond the reported revision could not be determined.No further medical assessment could be rendered 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 revealed this failure mode was previously identified.The anticipated risk level is still adequate.The instructions for use documents revealed this failure mode was previously identified.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.Some potential probable causes for this event could include but not limited to traumatic injury or surgical technique.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 32MM -3
• Common Device Name: PROSTHESIS,HIP,SEMICONSTRAINED METALCERAMICPOLYMER,CEMENTEDORNON-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: 13087555
• Report Number: 1020279-2021-08846
• Device Sequence Number: 5320432
• Product Code: LZO
• UDI-Device Identifier: 03596010474216
• UDI-Public: 03596010474216
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• 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: Other,Foreign,Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 01/25/2022

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: 71343203
• Device Catalogue Number: 71343203
• Device Lot Number: 21DM01265
• 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: 12/04/2021
• Supplement Date Received by Manufacturer: 01/22/2022
• Initial Report FDA Received Date: 12/27/2021
• Supplement Report FDA Received Date: 01/25/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 04/05/2021
• 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 Age: 62 YR
• Patient Sex: Female