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	Device Dislodged or Dislocated (2923)
Health Effect - Clinical Code	Joint Dislocation (2374)
Date of Event	12/05/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Internal complaint reference (b)(4).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 four weeks after a total hip replacement was performed, the patient reportedly experienced several episodes of hip dislocations.Additionally, a closed reduction procedure and a subsequent revision was performed with a construct conversion to a constrained r3 liner.As of the date of this medical investigation, the requested supporting clinical documentation (including the surgical technique) 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 multiple hip dislocations, closed reduction and revision cannot be determined and the patient¿s current health status was not provided.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 12/14 28mm +4 , 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.For the or3o dm xlpe insert 28/44 , 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 oxinium fem hd 12/14 28mm +4 , a review of the instructions for use documents for total hip systems revealed that dislocation has been identified in warnings and precautions, that may result from improper selection of the neck length and cup, stem positioning, muscle looseness and/or malpositioning of components.For the or3o dm xlpe insert 28/44 , a review of the instructions for use documents for or3o dual mobility system reveals in the potential complications associated with total hip arthroplasty surgery, primary or revision that dislocations, subluxation, decreased range of motion, or lengthening or shortening of the femur can occur.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 these products and event.At this time, we have no reason to suspect that the products failed to meet any product specifications at the time of manufacture.With the results of this investigation the root cause of this event could not be determined.Factors that could contribute to the reported event include traumatic injury, limited range of motion, patient anatomy, postoperative care or abnormal loading of limb.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.
Event or Problem Description
It was reported that, after a thr on (b)(6) 2022, the patient's hip dislocated several times in the weeks to follow and during closed reduction performed on (b)(6) 2022, one (1) oxinium femoral head 12/14 taper 28 mm +4 dissociated from one (1) or3o dual mobility xlpe insert 28/44.Revision surgery was performed on (b)(6) 2022 and construct was converted to a constrained r3 liner.

• 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: 16283442
• Report Number: 1020279-2023-00226
• Device Sequence Number: 6701385
• Product Code: LZO
• UDI-Device Identifier: 03596010474162
• UDI-Public: 03596010474162
• Combination Product (Y/N): N
• Initial Reporter State: IN
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• Device Explanted Year: 2022
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 02/02/2023

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?: Yes
• Operator of Device: Health Professional
• Device Model Number: 71342804
• Device Catalogue Number: 71342804
• Device Lot Number: 22EM08278
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/05/2022
• Initial Report FDA Received Date: 02/02/2023
• Date Device Manufactured: 05/12/2022
• 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: 71358219, LOT A2021526
• Outcome Attributed to Adverse Event: Required Intervention; Hospitalization
• Patient Sex: Unknown