MAUDE Adverse Event Report: SMITH & NEPHEW, INC. OXINIUM FEM HD 12/14 28MM +4; PRSTHSIS,HIP,SMI-CNSTRND,MTAL/CRMIC/PLYMR,CMNTDORNON-POROUS,UNCMNTD

Catalog Number	71342804
Medical Device Problem Code	Unintended Movement (3026)
Health Effect - Clinical Code	Joint Dislocation (2374)
Date of Event	09/30/2017
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported a tha revision surgery in an article due to dislocation.Disassociation of the acetabular liner flattening the femoral head.Stem and acetabular cup loose and effortless removed.
Additional Manufacturer Narrative
Additional information has been added on: if follow-up, what type, device evaluated by mfr.The associated complaint device was not returned.Without the actual device involved and/or device information, our investigation cannot proceed.If the device or new information is received in the future, the complaints can be re opened.The clinical medical investigation concluded, per the literature review, the improper seating of the liner and subsequent disassociation noted on the 3 year post op radiology findings resulted in the flattening of the femoral head.Intraoperative findings of necrosis and ¿metallosis¿ were consistent with adverse tissue reactions due to metal debris.The delay in the revision procedure was a contributing factor to the extensive component deformation and clinical symptoms/findings.The patient impact beyond the reported complaints, findings and revision will include annual surveillance.No further actions are being taken at this time.

• Brand Name: OXINIUM FEM HD 12/14 28MM +4
• Common Device Name: PRSTHSIS,HIP,SMI-CNSTRND,MTAL/CRMIC/PLYMR,CMNTDORNON-POROUS,UNCMNTD
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks road; memphis TN 38116
• MDR Report Key: 8348860
• Report Number: 1020279-2019-00668
• Device Sequence Number: 19322479
• Product Code: LZO
• UDI-Device Identifier: 03596010474162
• UDI-Public: 03596010474162
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• PMA/510(K) Number: K021673
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Explanted Year: 2017
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 06/13/2019

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 Catalogue Number: 71342804
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 01/28/2019
• Supplement Date Received by Manufacturer: 01/28/2019
• Initial Report FDA Received Date: 02/18/2019
• Supplement Report FDA Received Date: 06/13/2019
• 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: Other; Required Intervention
• Patient Age: 54 YR