MAUDE Adverse Event Report: SMITH & NEPHEW, INC. OXINIUM FEM HD 12/14 36 MM M/+4; PRSTHSS,HIP,SEMI-CONSTRAINED,METAL/POLYMER,CMNTD

Model Number	71343604
Medical Device Problem Codes	Unstable (1667); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Injury (2348); Joint Disorder (2373)
Date of Event	12/18/2017
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that a revision surgery was performed on the left hip due to fail tha, with grossly loose and unstable femoral component.Since pre-operatively, tha was diagnosed failed and afterwards, intraoperatively, the stem was noticed loose and the cup was removed, it cannot be discarded the incidence of the removed components to the tha failure.
Additional Manufacturer Narrative
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 the root cause of the first revision was the stated disarticulation of polyethylene from acetabular cup and loosening of the acetabular shell.What caused the disarticulation cannot be conclusively determined with the available information.The root cause of the second revision with the loosening of the femoral components and reported gluteus medius tear cannot be concluded if related to trauma or external factor during the noted camping trip or aseptic loosening of the femoral device.The very slight elevation of the chromium cannot be attributed to the ceramic and polyethylene hip articulation with a titanium stem.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.A review of risk management files and instructions for use found that the reported failure was documented appropriately.Factors and/or some potential probable causes that could contribute to the reported event have been identified as but not limited to abnormal motion over time, bone degeneration, design of device, fit/sizing, lack of ingrowth, lifetime of device, and traumatic injury.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.G1.

• Brand Name: OXINIUM FEM HD 12/14 36 MM M/+4
• Common Device Name: PRSTHSS,HIP,SEMI-CONSTRAINED,METAL/POLYMER,CMNTD
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks rd.; memphis TN 38116
• MDR Report Key: 10166252
• Report Number: 1020279-2020-02486
• Device Sequence Number: 2102060
• Product Code: JDI
• UDI-Device Identifier: 03596010477286
• UDI-Public: 03596010477286
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K022958
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Device Explanted Year: 2017
• Reporter Type: Manufacturer
• Report Source: company representative,consum
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 06/21/2021

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
• Operator of Device: Health Professional
• Device Model Number: 71343604
• Device Catalogue Number: 71343604
• Device Lot Number: 16MM05335
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 05/20/2020
• Supplement Date Received by Manufacturer: 06/16/2021
• Initial Report FDA Received Date: 06/18/2020
• Supplement Report FDA Received Date: 06/21/2021
• 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