MAUDE Adverse Event Report: SMITH & NEPHEW, INC. OXINIUM FEM HD 12/14 26 MM +4; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/CERAMIC/POLYMER, CEMENTED OR NON-POROUS

Model Number	71342604
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Fall (1848); Bone Fracture(s) (1870); Pain (1994)
Date of Event	05/11/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that, after a tka surgery was performed on (b)(6) 2023, the patient experienced pain and bone fracture.This adverse event was treated by a revision surgery on (b)(6) 2023, in which a anthology so porous size 6, an oxinium fem hd 12/14 26 mm + 4 and a tndm bp shl/xlpe lnr 49od 26id were exchanged.Patient's current health status is unknown.No more information is available.
Additional Manufacturer Narrative
H10: internal complaint reference: case(b)(4).
Additional Manufacturer Narrative
H3, h6.The devices were not returned for evaluation; therefore, devices analysis could not be performed.The clinical/medical investigation concluded that, per complaint details, a revision total knee arthroplasty was performed 10 days after implantation due to pain and bone fracture.As of the date of this medical investigation, the requested clinical documentation has not been provided for evaluation.It has been communicated via email correspondence within the attachments that further information is unavailable.However, it has been reported that the patient¿s pain and bone fracture were caused by the patient¿s fall and the surgeon decided it is not a product failure.The patient impact beyond the revision surgery could not be determined.No further clinical assessment is warranted at this time.A review of the production orders did not reveal a manufacturing abnormality that could have caused or contributed to the reported incident.A review of complaint history for the part numbers over the past 12 months and for the batch numbers based on historical data of the device did not reveal similar events for the listed devices.A review of the instructions for use documents for stem and femoral head of total hip systems revealed 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, revealed that 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, this has been identified as warnings and precautions.A review of the instructions for use documents of the liner of endoprostheses systems revealed that pain and fracture of the pelvis or femur is often caused by defects in the femoral cortex due to prior screw holes or misdirected reaming, this has been identified as adverse effects.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 product 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 patient bone quality, post-operative patient condition and/or surgical technique.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.H11: corrected information in h6 (health effect - clinical code).

• Brand Name: OXINIUM FEM HD 12/14 26 MM +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: 17095880
• Report Number: 1020279-2023-01257
• Device Sequence Number: 1932375
• Product Code: LZO
• UDI-Device Identifier: 03596010488909
• UDI-Public: 03596010488909
• 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): 06/29/2023

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: 71342604
• Device Catalogue Number: 71342604
• Device Lot Number: 22MM12486
• 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: 05/16/2023
• Supplement Date Received by Manufacturer: 06/27/2023
• Initial Report FDA Received Date: 06/09/2023
• Supplement Report FDA Received Date: 06/29/2023
• Date Device Manufactured: 12/19/2022
• 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: ANTHOLOGY SO POROUS SIZE 6, LOT#:20GM12674.; TNDM BP SHL/XLPE LNR 49OD 26ID, LOT#:23AM09845.
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Sex: Unknown