MAUDE Adverse Event Report: SMITH & NEPHEW, INC. OXINIUM FEM HD 12/14 32MM +0; PROSTH, HIP, SEMI-CONST, MET/CERAM/POLY, CEMENT OR NON-POROUS, UNCEMENT

Catalog Number 71343200

Device Problem Device Dislodged or Dislocated (2923)

Patient Problem Injury (2348)

Event Date 07/23/2020

Event Type  Injury  

Event Description

It was reported that the patient had primary hip replacement on (b)(6) 2020.Revision surgery was performed due to recurrent dislocations (x-ray).Cup/liner/head were removed.Surgeon changed version and longer head to restore offset/leg length.Same size cup/liner inserted with screw 35mm length and central screw hole cover.Ox +4 head 32mm implanted (longer than previous).Surgeon commented reason for revision was due to cup malpositioning (too anteverted) and not enough offset/length.Not a product fault.

Manufacturer Narrative

It was reported that the patient had primary hip replacement on 6-7-2020.Revision surgery was performed due to recurrent dislocations.Cup/liner/head were removed.The affected complaint device, used in treatment, was not returned for evaluation.Therefore a product analysis could not be performed.A review of the complaint history on the listed part revealed no prior complaints for the listed failure mode with the same batch number.A review of the manufacturing records for the listed batch did not reveal any deviation from the standard manufacturing processes.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 risk management files and the instructions for use found that the reported failure was documented appropriately.A clinical analysis noted that two un-dated x-rays have been provided for review and did not add to the investigation.No additional medical documents were received for investigation.Therefore no further medical assessment can be performed at this time.Surgeon stated the failure was due to cup malpositioning (too anteverted) and not enough offset/length, and not a product failure.Based on this investigation, the need for corrective action is not indicated.No further investigation is warranted for this complaint; however we will continue to monitor for future complaints and investigate as necessary.Should the device or additional information be received, the complaint will be reopened.We consider this investigation closed.

• Brand Name: OXINIUM FEM HD 12/14 32MM +0
• Type of Device: 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: 10608066
• MDR Text Key: 209219798
• Report Number: 1020279-2020-04978
• Device Sequence Number: 1
• Product Code: LZO
• Combination Product (y/n): N
• PMA/PMN Number: K021673
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 11/05/2020

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
• Device Operator: Health Professional
• Device Catalogue Number: 71343200
• Device Lot Number: 19BM16253
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 07/23/2020
• Initial Date FDA Received: 09/30/2020
• Supplement Dates Manufacturer Received: 11/02/2020
• Supplement Dates FDA Received: 11/05/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Other; Required Intervention