MAUDE Adverse Event Report: SMITH & NEPHEW, INC. OXINIUM FEM HD 12/14 32MM -3; PROSTH, HIP, SEMI-CONST, MET/CERAM/POLY, CEMENT OR NON-POROUS, UNCEMENT

Model Number	71343203
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Pain (1994)
Date of Event	04/12/2021
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that, after a hip surgery the patient felt pain.The adverse event was addressed with a revision surgery to remove an oxinium fem hd 12/14 32mm -3.The condition of the patient is unknown.
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, the ox head was revised secondary to pain felt post-revision with a mixed manufacturer construct (mallory cup).It was communicated that no further information would be provided due to lack of consent.Reportedly, pain was the root cause of the reported events; however, the mixed manufacturer construct could not be ruled out as a potential contributing factor although no supporting documentation was provided.The patient impact beyond the reported revision and anticipated post-op recovery phase could not be determined.No further medical assessment is warranted at this time.Should clinically relevant documentation/information become available, the clinical/medical task may be re-evaluated.A complaint history review found related failures for the listed device; this failure mode will be monitored for future complaints for any necessary corrective actions.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 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.We consider this investigation closed.

• Brand Name: OXINIUM FEM HD 12/14 32MM -3
• Common Device Name: PROSTH, HIP, SEMI-CONST, MET/CERAM/POLY, CEMENT OR NON-POROUS, UNCEMENT
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks rd.; memphis TN 38116
• MDR Report Key: 11781906
• Report Number: 1020279-2021-03803
• Device Sequence Number: 3179730
• Product Code: LZO
• UDI-Device Identifier: 03596010474216
• UDI-Public: 03596010474216
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Explanted Year: 2021
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 08/18/2021

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?: No
• Operator of Device: Health Professional
• Device Model Number: 71343203
• Device Catalogue Number: 71343203
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 04/12/2021
• Supplement Date Received by Manufacturer: 08/16/2021
• Initial Report FDA Received Date: 05/06/2021
• Supplement Report FDA Received Date: 08/18/2021
• 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; Other; Required Intervention