MAUDE Adverse Event Report: SMITH & NEPHEW, INC. OXINIUM FEM HD 12/14 32MM +8; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/CERAMIC/POLYMER, CEMENTED OR NON-POROUS

Model Number	71343208
Medical Device Problem Code	Material Erosion (1214)
Health Effect - Clinical Codes	Infiltration into Tissue (1931); Joint Laxity (4526); Metal Related Pathology (4530)
Date of Event	07/13/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Internal complaint reference: (b)(4).
Event or Problem Description
It was reported that, after a revision thr had been performed on (b)(6) 2021, the patient experienced instability.A revision surgery was performed on (b)(6) 2022 to address this event.During exposure, the surgeon noticed dark colored fluid in the wound while removing the components along with catastrophic wear on the oxinium head.Surgeon cleaned the site and implanted a 40mm oxinium head/sleeve with appropriate cup/liner.The current health status of patient is unknown.
Additional Manufacturer Narrative
H3, h6.The device was not returned for evaluation.The reported event could be confirmed as the x-ray was reviewed by the clinical/medical team and it appears to show clouding from metal debris fluid, that would be consistent with the reported dark colored fluid.The clinical/medical investigation concluded that, although the acetabular shell construct and manufacturer are unknown, the surgeons choice of revision components likely lead to increased wear, the reported instability and dark colored fluid in the wound.Therefore, the implantation of the oxinium head and poly liner onto the already existing shell, after the ceramic head and liner fractured cannot be ruled out as a contributing factor to the reported events.With the information provided, the patient impact beyond the revision and expected transient post-op convalescence period cannot be determined.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 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.A review of the instructions for use documents for total hip systems revealed that wear of the polyethylene, metal and ceramic articulating surfaces of acetabular components may occur as an adverse event.Higher rates of wear may be initiated by the presence of particles of cement, metal, or other debris which can develop during or as a result of the surgical procedure and cause abrasion of the articulating surfaces.A review of the risk management file 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 evidence to suspect that the product failed to meet any product specifications at the time of manufacture.Potential causes could include but are not limited to surgeons choice of revision components, friction, surgical procedure or joint tightness.The contribution of the device to the reported incident could be corroborated as the x-rays confirm the presence of metal debris fluid and it was required a revision surgery to treat this event.Based on this investigation, the need for corrective action is not indicated.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.H11: corrected data in h6 (health effect - clinical code).

• Brand Name: OXINIUM FEM HD 12/14 32MM +8
• 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: 15136638
• Report Number: 1020279-2022-03555
• Device Sequence Number: 5268500
• Product Code: LZO
• UDI-Device Identifier: 03596010474230
• UDI-Public: 03596010474230
• Combination Product (Y/N): N
• Initial Reporter State: NC
• 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: 2022
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 09/01/2022

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?: Yes
• Operator of Device: Health Professional
• Device Model Number: 71343208
• Device Catalogue Number: 71343208
• Device Lot Number: 19GM25234
• 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: 07/13/2022
• Supplement Date Received by Manufacturer: 08/31/2022
• Initial Report FDA Received Date: 07/29/2022
• Supplement Report FDA Received Date: 09/01/2022
• Date Device Manufactured: 07/31/2019
• 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: Hospitalization; Required Intervention
• Patient Age: 62 YR
• Patient Sex: Male