MAUDE Adverse Event Report: SMITH & NEPHEW, INC. OXINIUM FEM HD 12/14 22 MM +0; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/CERAMIC/POLYMER,

Model Number	71342200
Medical Device Problem Code	Patient Device Interaction Problem (4001)
Health Effect - Clinical Codes	Failure of Implant (1924); Pain (1994); Joint Dislocation (2374)
Date of Event	08/08/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).
Event or Problem Description
It was reported that, after a thr surgery was performed on (b)(6) 2021, the patient experienced acute pain in the left hip and the left prosthesis was dislocated.The patient underwent a revision surgery.This issue is still being resolved.
Additional Manufacturer Narrative
H3, h6: the device, used in treatment, was not returned for evaluation and the reported event could not be confirmed.The clinical/medical investigation concluded that, this case reports patient experienced left hip pain, dislocation, and a revision after a thr.Per email communication, the patient current health status is reportedly ¿resolving.¿ no additional clinically relevant information was provided.Based on the information provided, the clinical root cause of the reported events could not be definitively concluded.The impact beyond the reported symptoms and subsequent revision cannot 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 additional complaints for the listed batch.A review of the risk management file and instructions for use documents revealed this failure mode was previously identified.At this time, we have no reason to suspect that the product failed to meet any product specifications at the time of manufacture.Possible causes could include but not limited to traumatic injury, joint tightness, material in use, patient reaction, patient anatomy, abnormal loading of limb or loss of sterility.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.

• Brand Name: OXINIUM FEM HD 12/14 22 MM +0
• Common Device Name: PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/CERAMIC/POLYMER,
• 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; austin, TX 78735 ; 5123913905
• MDR Report Key: 12538264
• Report Number: 1020279-2021-07225
• Device Sequence Number: 19189514
• Product Code: LZO
• UDI-Device Identifier: 03596010488862
• UDI-Public: 03596010488862
• Combination Product (Y/N): N
• Initial Reporter State: NV
• Initial Reporter Country: US
• PMA/510(K) Number: K021673
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• 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): 11/05/2021

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: 71342200
• Device Catalogue Number: 71342200
• Device Lot Number: 21EM16061
• 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: 09/09/2021
• Supplement Date Received by Manufacturer: 11/04/2021
• Initial Report FDA Received Date: 09/27/2021
• Supplement Report FDA Received Date: 11/07/2021
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 05/24/2021
• 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: Initial
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: OR3O DM XLPE INSERT 22/40/ A2011581.; POLARSTEM STEM STD TI/HA 2 NON-CEM/B2021058.; R3 3 HOLE ACET SHELL 52MM/21CW04279.; OR3O DM XLPE INSERT 22/40/ A2011581.; POLARSTEM STEM STD TI/HA 2 NON-CEM/B2021058.; R3 3 HOLE ACET SHELL 52MM/21CW04279.
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Female
• Patient Weight: 75 KG