MAUDE Adverse Event Report: SMITH & NEPHEW, INC. OXINIUM FEM HD 12/14 28MM +4; PROSTHESIS,HIP,SEMI-CNSTRND,METAL/CERAMIC/PLYMR,CEMENTED OR NON-POROUS, UNCMNTD

Model Number 71342804

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Injury (2348)

Event Date 09/11/2020

Event Type  Injury  

Event Description

It was reported that revision surgery was performed due to recurrent dislocation.Head and liner were explanted and changed for pats of the same size.The other implants remained in situ.No information about the patient status was initially provided.

Manufacturer Narrative

H3, h6: 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 was received assembled in a liner.The interior of the taper and outer face of the device has signs of damage from implantation.A dimensional evaluation could not be performed due to the device being assembled and damaged from implantation.The clinical/medical evaluation concluded that it was reported that revision surgery was performed due to recurrent dislocation.Head and liner were explanted and changed for pats of the same size.The other implants remained in situ.No information about the patient status was provided.Smith and nephew has not received the device/adequate materials to fully evaluate the complaint, but if additional clinically relevant materials are later received, then the case may be re-opened for further evaluation.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 and potential harm was previously identified.Possible causes could include but not limited to traumatic injury, patient anatomy or abnormal loading of limb.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
• Type of Device: PROSTHESIS,HIP,SEMI-CNSTRND,METAL/CERAMIC/PLYMR,CEMENTED OR NON-POROUS, UNCMNTD
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks rd.; memphis TN 38116
• MDR Report Key: 10652445
• MDR Text Key: 210511902
• Report Number: 1020279-2020-05264
• Device Sequence Number: 1
• Product Code: LZO
• UDI-Device Identifier: 03596010474162
• UDI-Public: 03596010474162
• 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,health
• Type of Report: Initial,Followup
• Report Date: 08/09/2021

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
• Device Operator: Health Professional
• Device Model Number: 71342804
• Device Catalogue Number: 71342804
• Device Lot Number: 20BM21010
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/29/2020
• Initial Date Manufacturer Received: 09/11/2020
• Initial Date FDA Received: 10/08/2020
• Supplement Dates Manufacturer Received: 08/08/2021
• Supplement Dates FDA Received: 08/09/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention