MAUDE Adverse Event Report: SMITH & NEPHEW, INC. OXINIUM FEM HD 12/14 26 MM +4; PROSTHESIS HIP SEMICONSTRAINEDMETALCERAMICPOLYME CEMNTED OR NONPOROUS UNCEMNTED

Catalog Number	71342604
Medical Device Problem Code	Device Dislodged or Dislocated (2923)
Health Effect - Clinical Code	Injury (2348)
Date of Event	12/25/2018
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that a revision surgery was performed due to dislocation.
Additional Manufacturer Narrative
The associated tandem shell/liner, oxinium femoral head and polarstem cementless stem were not returned for evaluation.After repeated requests, smith and nephew has been unable to obtain device details.As batch information were not made available, a review of the device history record cannot be completed.Without the return of the actual product involved, our investigation of this report is inconclusive.A clinical evaluation noted that no clinical relevant documents were provided to conduct a thorough medical assessment.However, the dislocation was reportedly the cause for the revision 7 years post implantation, although the cause for dislocation cannot be determined and it cannot be determined if the reported dementia contributed to the event based on the complaint description alone.Patient impact beyond the reported dislocation and subsequent revision cannot be concluded.No further investigation is warranted for this complaint; however we will continue to monitor for future complaints and investigate as necessary.Should additional information be received, the complaint will be reopened.We consider this investigation closed.

• Brand Name: OXINIUM FEM HD 12/14 26 MM +4
• Common Device Name: PROSTHESIS HIP SEMICONSTRAINEDMETALCERAMICPOLYME CEMNTED OR NONPOROUS UNCEMNTED
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks road; memphis TN 38116
• MDR Report Key: 8264366
• Report Number: 1020279-2019-00217
• Device Sequence Number: 19232817
• Product Code: LZO
• UDI-Device Identifier: 03596010488909
• UDI-Public: 03596010488909
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K021673
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2011
• Device Explanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 04/12/2019

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: 71342604
• Device Lot Number: UNKNOWN
• Initial Date Received by Manufacturer: 12/25/2018
• Supplement Date Received by Manufacturer: 12/25/2018
• Initial Report FDA Received Date: 01/21/2019
• Supplement Report FDA Received Date: 04/12/2019
• 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: Hospitalization; Required Intervention