MAUDE Adverse Event Report: SMITH & NEPHEW, INC. OXINIUM FEM HD 12/14 22 MM +4; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/CERAMIC/POLYMER, CEMENTED OR NON-POROUS

Model Number	71342204
Medical Device Problem Code	Connection Problem (2900)
Health Effect - Clinical Code	Joint Dislocation (2374)
Date of Event	05/22/2020
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that, after a or3o system had been implanted in a thr surgery, the patient presented a dislocated dual mobility prosthesis.A closed reduction was performed to alleviate the problem; however, upon obtaining x-rays, eccentricities were discovered between the shell and the femoral neck on the stem, which was also confirmed with a ct scan, so the patient was scheduled for revision surgery the next day.During the revision surgery, the shell was found to be well fixed.The stem was also well fixed with the femoral head still attached to the morse taper.The dual mobility plastic bearing was detached from the femoral head and was not inside the dual mobility liner.The surgeon (i) removed both the cup and cemented stem and placed a 4mm larger r3 cup (54mm) in a more anteverted position; (ii) downsized the stem while converting to a high offset implant, placing it in a more superior position; and (iii) chose to use again an or3o dual mobility implant with this construct.The patient outcome is unknown.
Additional Manufacturer Narrative
The device, used in treatment, was not returned for evaluation and the reported event could not be confirmed.The clinical/medical investigation concluded that based on the provided information, the root cause of the dislocation and subsequent revision could not be definitively concluded; however, the anteversion/positioning of the primary construct and possible inadequate post-op hip precautions could not be ruled out as possible contributing factors to the reported events.The patient impact beyond the reported dislocation, probable pain, closed reduction and subsequent revision could not be determined as the patient¿s status remains unknown.No further medical assessment can be rendered at this time.Should additional clinical documentation become available in the future, the clinical/medical task may be re-evaluated.No further medical assessment is warranted at this time.A review of complaint history did not reveal additional complaints for the listed batch.A review of the manufacturing records did not reveal a manufacturing abnormality that could have caused or contributed to the reported incident.At this time, we have no reason to suspect that the product failed to meet any product specifications at the time of manufacture.A review of the risk management file and instructions for use documents revealed this failure mode and potential harm was previously identified.Possible causes could include but not limited to traumatic injury, patient anatomy or abnormal loading of limb.Based on this investigation, the need for corrective action is not indicated.Without the return of the actual product involved or product information, 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.We consider this investigation closed.

• Brand Name: OXINIUM FEM HD 12/14 22 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
• MDR Report Key: 10171684
• Report Number: 1020279-2020-02556
• Device Sequence Number: 2318315
• Product Code: LZO
• UDI-Device Identifier: 03596010488879
• UDI-Public: 03596010488879
• Combination Product (Y/N): N
• Initial Reporter State: NE
• Initial Reporter Country: US
• PMA/510(K) Number: K121673
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Device Explanted Year: 2020
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 06/23/2021

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: 71342204
• Device Catalogue Number: 71342204
• Device Lot Number: 19EM04995
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 05/25/2020
• Supplement Date Received by Manufacturer: 06/18/2021
• Initial Report FDA Received Date: 06/18/2020
• Supplement Report FDA Received Date: 06/23/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Age: 76 YR
• Patient Weight: 69