MAUDE Adverse Event Report: SMITH & NEPHEW, INC. OXINIUM FEM HD 12/14 32MM -3; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/CERAMIC/POLYMER, CEMENTED OR NON-POROUS

Model Number	71343203
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Bone Fracture(s) (1870); Pain (1994)
Date of Event	04/07/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that after a thr that was performed on (b)(6) 2023, a revision surgery was performed on (b)(6) 2023 due to pain and fracture from a fall.A polarstem stem std ti/ha 2 non-cem and an oxonium fem hd 12/14 32mm -3 were extracted and replaced.The current patient status is unknown.
Additional Manufacturer Narrative
H10: internal complaint reference: (b)(4).
Additional Manufacturer Narrative
H3, h6: the devices were not returned for evaluation; therefore, a device analysis could not be performed.The clinical/medical investigation concluded that, per case details, approximately two weeks after a total hip replacement surgery was performed, the patient reportedly underwent a revision ¿due to pain and a fracture from a fall.¿ reportedly, the polarstem and oxinium femoral components were removed and replaced.Per the case communication, ¿the surgeon thinks it is not the product failure because the patient fell.¿ as of the date of this medical investigation, the requested clinical documentation has not been provided; therefore, there were no clinical factors found which would have definitively contributed to the event.The patient impact beyond the reported symptoms and events including the fracture, and revision cannot be determined, and patient¿s current health status is unknown.Therefore, no further clinical/medical assessment can be rendered.A review of the production orders did not reveal a manufacturing abnormality that could have caused or contributed to the reported incident.For the oxinium fem hd, 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.For the polarstem, a review of complaint history revealed similar events for the listed device over the previous 12 months, but no similar events for the batch based on the historical data, this failure mode will be monitored for future complaints for any necessary corrective actions.A review of the instructions for use documents for total hip systems revealed in warnings and precautions that the patient should be advised to report any pain and unusual incidences.Position changes in the components may compromise the durability of the implants.Also, congenital deformity, improper implant selection, improper broaching or reaming, osteoporosis, bone defects due to misdirected reaming, trauma, strenuous activity, improper implant alignment or placement, patient non-compliance, etc.Can increase risk of femoral or pelvic fractures.A review of the risk management files 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 products and event.At this time, we have no reason to suspect that the products failed to meet any specifications at the time of manufacture.Factors that could contribute to the reported event include traumatic injury, joint tightness, patient condition or postoperative care.Based on this investigation, the need for corrective action is not indicated.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 -3
• 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: 16829716
• Report Number: 1020279-2023-00931
• Device Sequence Number: 13908588
• Product Code: LZO
• UDI-Device Identifier: 03596010474216
• UDI-Public: 03596010474216
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K021673
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2023
• Device Explanted Year: 2023
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 05/30/2023

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: 22GM16317
• 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: 04/07/2023
• Supplement Date Received by Manufacturer: 05/25/2023
• Initial Report FDA Received Date: 04/28/2023
• Supplement Report FDA Received Date: 05/30/2023
• Date Device Manufactured: 07/26/2022
• 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
• Concomitant Medical Products and Therapy/Usage Dates: POLARSTEM STEM STD TI/HA 2 NON-CEM, LOT#:C2218575
• Outcome Attributed to Adverse Event: Required Intervention; Hospitalization
• Patient Sex: Unknown