MAUDE Adverse Event Report: SMITH & NEPHEW, INC. OXNM FEM HD 28MM +12; PROSTH, HIP, SEMI-CONST, MET/CERAM/POLY, CEMENT OR NON-POROUS, UNCEMENT

Model Number	71342812
Medical Device Problem Code	Device Dislodged or Dislocated (2923)
Health Effect - Clinical Code	Injury (2348)
Date of Event	09/17/2019
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that during a revision surgery the 28mm + 12 head was replaced with an oxinium 28mm +16 head, because the patient was very unstable and dislocated.Back-up device available, no delay reported.
Additional Manufacturer Narrative
Additional information: d4, h4.It was reported that a revision surgery was performed due to patient instability and dislocation.The associated oxinium femoral head, used in treatment, was not returned for evaluation.Thus the product analysis could not be performed.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.At this time, we have no reason to suspect that the product failed to meet any product specifications at the time of manufacture.A relationship, if any, between the device and the reported incident could not be corroborated.A review of instructions for use revealed the alleged failure is previously identified in the possible adverse events.Per our risk assessment, probable causes were stated to include but not limited to patient anatomy or surgical technique.No medical documents were received for investigation.Therefore no medical assessment can be performed at this time.Without the return of the actual product involved and no patient history records, our investigation of this report is inconclusive.Based on this investigation, the need for corrective action is not indicated.No further investigation warranted for this complaint; however we will continue to monitor for future complaints and investigate as necessary.Should additional information be received, the complaint will be reopened.

• Brand Name: OXNM FEM HD 28MM +12
• 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: 9187403
• Report Number: 1020279-2019-03644
• Device Sequence Number: 2172228
• Product Code: LZO
• UDI-Device Identifier: 03596010474186
• UDI-Public: 03596010474186
• 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: 2019
• Device Explanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 02/03/2020

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: 71342812
• Device Catalogue Number: 71342812
• Device Lot Number: 17DM11892
• Initial Date Received by Manufacturer: 09/17/2019
• Supplement Date Received by Manufacturer: 01/29/2020
• Initial Report FDA Received Date: 10/14/2019
• Supplement Report FDA Received Date: 02/03/2020
• 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