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	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Joint Dislocation (2374)
Date of Event	10/01/2020
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that, after a thr had been performed on (b)(6) 2020, the patient experienced a dislocation after a fall.A revision surgery was performed on (b)(6) 2020 to exchange the oxinium femoral head.The patient outcome is unknown.
Additional Manufacturer Narrative
The associated device, used in treatment, was returned and evaluated.A visual inspection of the returned device could not confirm the stated failure mode.The device has signs of damage from implantation / extraction.The device was manufactured in 2020.The clinical medical investigation concluded that although a 300 crp was noted, it should also be noted the patient has a history of autoimmune disease.The dislocation, closed reduction and subsequent revision are a result of the patient fall and is not associated with a malperformance of the implant.The patient impact beyond the revision and expected transient post-op convalescence period cannot be determined.The dimensional evaluation found the device to be with specification.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 do not have 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 was previously identified.A potential probable cause for this event could include but is not limited to a fall or traumatic injury.Based on this investigation, the need for corrective action is not indicated.Should 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 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
• MDR Report Key: 10815696
• Report Number: 1020279-2020-06337
• Device Sequence Number: 1872275
• Product Code: LZO
• UDI-Device Identifier: 03596010474162
• UDI-Public: 03596010474162
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: K021673
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 08/05/2021

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: 71342804
• Device Catalogue Number: 71342804
• Device Lot Number: 20EM09051
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/01/2021
• Initial Date Received by Manufacturer: 10/21/2020
• Supplement Date Received by Manufacturer: 08/05/2021
• Initial Report FDA Received Date: 11/10/2020
• Supplement Report FDA Received Date: 08/05/2021
• 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