MAUDE Adverse Event Report: SMITH & NEPHEW, INC. OXINIUM FEM HD 12/14 28MM -3; PRSTHSISHIPSMICNSTRINDMTALCERMICPLYMRCMNTDORNONPRUSUNEMNTD

Model Number	71342803
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Injury (2348)
Date of Event	02/10/2020
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that a revision surgery was performed due to infection.Patient had diabetic reflux and hypertension.Surgeon used previous incision to open joint and dislocated the hip.Head and liner was removed via punch.Stem was removed via flexible osteotomes and removal tool.Cup removed by explant.Cement spacer inserted.Original surgery performed on (b)(6) 2019 due to rheumatoid arthritis.
Additional Manufacturer Narrative
The device, used in treatment, was not returned for evaluation and the reported event could not be confirmed.At this time, we have no reason to suspect that the product failed to meet any product specifications at the time of manufacture.A complaint history review found related failures; this failure mode will be monitored for future complaints for any necessary corrective actions.A review of the risk management file and instructions for use document for this failure mode was conducted and concluded this failure mode has been identified.Our clinical/medical team noted: it was reported that a revision surgery was performed (b)(6) 2020 due to infection.It is also noted the surgeon used the previous incision to open joint and dislocated the hip.Head and liner was removed via punch.Stem was removed via flexible osteotomes and removal tool.Cup removed by explant.Cement spacer inserted.However, to date no medical records have been received.Without any supporting medical documentation, the reported event cannot be assessed, and a thorough medical assessment cannot be performed.In the event of medical/clinical records being received, the clinical task will be re-opened and a thorough assessment will be rendered at that time.At this time a root cause could not be determined with the information provided.Based on this investigation, the need for corrective action is not indicated.Without the return of the actual product involved, our investigation could not proceed.Should the device or additional information be received, the complaint will be reopened.No further investigation warranted for this complaint; however we will continue to monitor for future complaints and investigate as necessary.

• Brand Name: OXINIUM FEM HD 12/14 28MM -3
• Common Device Name: PRSTHSISHIPSMICNSTRINDMTALCERMICPLYMRCMNTDORNONPRUSUNEMNTD
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks road; memphis TN 38116
• MDR Report Key: 9792392
• Report Number: 1020279-2020-00786
• Device Sequence Number: 19415856
• Product Code: LZO
• UDI-Device Identifier: 03596010474155
• UDI-Public: 03596010474155
• Combination Product (Y/N): N
• PMA/510(K) Number: K021673
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Device Explanted Year: 2020
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 11/10/2020

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
• Operator of Device: Health Professional
• Device Model Number: 71342803
• Device Catalogue Number: 71342803
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 02/10/2020
• Supplement Date Received by Manufacturer: 11/05/2020
• Initial Report FDA Received Date: 03/05/2020
• Supplement Report FDA Received Date: 11/10/2020
• 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