MAUDE Adverse Event Report: SMITH & NEPHEW, INC. OXINIUM FEM HD 12/14 22 MM +0; PROSTH, HIP, SEMI-CONST, MET/CERAM/POLY, CEMENT OR NON-POROUS, UNCEMENT

Catalog Number	71342200
Medical Device Problem Code	Device Dislodged or Dislocated (2923)
Health Effect - Clinical Code	Injury (2348)
Date of Event	11/23/2016
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported a revision surgery due to dislocation of the left hip.
Additional Manufacturer Narrative
It was reported a revision surgery due to dislocation of the left hip.The only part returned for evaluation was the r3 constrained liner.This case has been re-opened due to additional information received.The additional parts are the oxinium femoral head, the acetabular shell and the emperion stem which were not returned.A clinical analysis noted that the root cause of the revision is due to the patient¿s multiple dislocations, which can likely be attributed to her multiple falls.The pre-revision x-rays indicated that the prosthesis was well positioned with no evidence of loosening.The intraoperative finding of ¿dead tissue¿ during the revision is likely a result of the ongoing psoas abscess and infection.The root cause of the infection and abscess cannot be concluded.The patient impact beyond the revision and post-operative healing/pain cannot be determined.It was reported that the patient was doing well at last office visit.No further clnical assessment is warranted at this time.Our investigation including a review of the manufacturing records for the listed batch did not reveal any deviation from the standard manufacturing processes.A review of the complaint history for the listed part revealed no prior complaints for the listed failure mode with the same batch number.The devices were sterilized according to sterilization release documentation from quality control.At this time, we have no reason to suspect that the products failed to meet any product specifications at the time of manufacture.A relationship, if any, between the devices and the reported incident or adverse event could not be corroborated.No further investigation is warranted for this complaint; however smith and nephew will continue to monitor for future complaints and investigate as necessary.Should additional information be received, the complaint will be reopened.

• Brand Name: OXINIUM FEM HD 12/14 22 MM +0
• Common Device Name: PROSTH, HIP, SEMI-CONST, MET/CERAM/POLY, CEMENT OR NON-POROUS, UNCEMENT
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks road; memphis TN 38116
• MDR Report Key: 9268894
• Report Number: 1020279-2019-03860
• Device Sequence Number: 19401135
• Product Code: LZO
• UDI-Device Identifier: 03596010488862
• UDI-Public: 03596010488862
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K021673
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2016
• Device Explanted Year: 2016
• Reporter Type: Manufacturer
• Report Source: other
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 12/03/2019

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 Expiration Date: 07/25/2026
• Device Catalogue Number: 71342200
• Device Lot Number: 16GM17855
• Initial Date Received by Manufacturer: 10/02/2019
• Supplement Date Received by Manufacturer: 10/02/2019
• Initial Report FDA Received Date: 11/01/2019
• Supplement Report FDA Received Date: 12/03/2019
• 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: 61 YR