MAUDE Adverse Event Report: SMITH & NEPHEW, INC. OXINIUM FEM HD 12/14 26 MM +0; PROST,HIP,SEMCONSTR,MET/CER/POLY,CEMNTORNON-POR,UNCEMNT

Model Number 71342600

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

Patient Problems Failure of Implant (1924); Injury (2348); Joint Dislocation (2374)

Event Date 09/24/2020

Event Type  Injury  

Event Description

It was reported that revision surgery was performed due to dislocation.No more information was initially provided.

Manufacturer Narrative

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 has signs of damage from implantation / extraction.The clinical / medical investigation concluded that this complaint from japan reports that a revision was performed secondary to dislocations.The primary surgery was on (b)(6) 2020 and the revision just 2 months later on (b)(6) 2020.It has been communicated that no further documentation would be forthcoming.Smith and nephew has not received adequate materials (operative reports) to fully evaluate the complaint, but if additional clinically relevant materials are later received, then the case may be re-opened for further evaluation.The dimensional evaluation could not confirm the stated failure mode.The device was found to be within specification.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 was previously identified.Some potential probable causes for this event could include a fit/ sizing issue or procedural error.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 26 MM +0
• Type of Device: PROST,HIP,SEMCONSTR,MET/CER/POLY,CEMNTORNON-POR,UNCEMNT
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks rd.; memphis TN 38116
• MDR Report Key: 10745216
• MDR Text Key: 213377589
• Report Number: 1020279-2020-05870
• Device Sequence Number: 1
• Product Code: LZO
• UDI-Device Identifier: 03596010488893
• UDI-Public: 03596010488893
• 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: 05/31/2021

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: Lay User/Patient
• Device Model Number: 71342600
• Device Catalogue Number: 71342600
• Device Lot Number: 20BM21221
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/12/2020
• Initial Date Manufacturer Received: 10/01/2020
• Initial Date FDA Received: 10/28/2020
• Supplement Dates Manufacturer Received: 05/28/2021
• Supplement Dates FDA Received: 05/31/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: 75000176/SL-PLUS INTEGR MIA STEM WITH TI/HA 3/UNKN; 75000176/SL-PLUS INTEGR MIA STEM WITH TI/HA 3/UNKN
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 70 YR