MAUDE Adverse Event Report: SMITH & NEPHEW, INC. OXINIUM FEM HD 12/14 32MM +0; PROSTHESIS,HIP,SEMI-CONSTRAINED,METAL/CERAMIC/PLYMR,CMNTD OR NON-POROUS,UNCMNTD

Model Number 71343200

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

Patient Problem Injury (2348)

Event Date 10/21/2020

Event Type  Injury  

Event Description

It was reported that the patient suffered a periprosthetic fracture of the femur below a hip replacement.This was fixed with a stryker plate ,subsequently the stem has subsided due to non union of the fracture.It is unknown when this happened or the patient health.

Manufacturer Narrative

H3, h6: the device, used in treatment, was not returned for evaluation.Therefore, product analysis could not be performed at this time.So the reported event could not be confirmed.A medical investigation was conducted and confirms per complaint details, a patient has experienced stem subsidence secondary to non-union following a distal femoral periprosthetic fracture (ppf) which was reportedly treated with a stryker competitor plate.It was communicated that the requested medical documentation and the explanted components were not available for inclusion in the medical investigation.Reportedly the root cause of the subsidence was the non-union; however, the root cause of the ppf along with other surgical details remains unknown.The patient impact beyond the reported ppf, plating, stem subsidence 2nd to non-union, and subsequent revision could not be determined, as the patient¿s status was ¿unknown¿.No further medical assessment is warranted at this time.Should additional information/ documentation become available, the clinical/medical task may be re-opened for further evaluation.A complaint history review found related failures; this failure mode will be monitored for future complaints for any necessary corrective actions.A review of risk management files and instructions for use found that the reported failure was documented appropriately.Factors and/or potential causes that could contribute to the reported event have been identified in the risk management file, include but not limited to excessive forces applied to implant and inadequate design.At this time, we have no reason to suspect that the product failed to meet any product specifications at the time of manufacture.Based on this investigation, the need for corrective action is not indicated.Without the actual product involved and/or device information, our investigation cannot proceed.If the device or new information is received in the future, this complaint can be re-opened.No further actions are being taken at this time.We consider this investigation closed.

• Brand Name: OXINIUM FEM HD 12/14 32MM +0
• Type of Device: PROSTHESIS,HIP,SEMI-CONSTRAINED,METAL/CERAMIC/PLYMR,CMNTD OR NON-POROUS,UNCMNTD
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks rd.; memphis TN 38116
• MDR Report Key: 10814349
• MDR Text Key: 215461197
• Report Number: 1020279-2020-06313
• Device Sequence Number: 1
• Product Code: LZO
• UDI-Device Identifier: 03596010474209
• UDI-Public: 03596010474209
• 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: 07/29/2021

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: 71343200
• Device Catalogue Number: 71343200
• Initial Date Manufacturer Received: 10/21/2020
• Initial Date FDA Received: 11/09/2020
• Supplement Dates Manufacturer Received: 07/28/2021
• Supplement Dates FDA Received: 07/29/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention