MAUDE Adverse Event Report: SMITH & NEPHEW, INC. OXINIUM HD 10/12 26MM +0 EXT; PROSTHESIS, HIP, SEMI-CONSTRAINED, MRAMC/POLYMR, CMNTD OR NN-PRS, UNCMENTED

Catalog Number	71341910
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Codes	Unspecified Infection (1930); 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 infection.
Additional Manufacturer Narrative
The affected tandem shell/liner and oxinium femoral head were not returned for evaluation.A clinical analysis noted that no clinical relevant documentation was provided, therefore, a thorough medical investigation could not be performed.However, it was communicated that the revision surgery was performed due to infection.The patient impact beyond the reported revision for infection, probable antibiotic therapy, and an expected brief post-op convalescence period cannot be determined.No further medical assessment is warranted at this time.As device details were not made available, device history record review cannot be completed.Batch number was not provided, a sterilization review cannot be conducted at this time.Without the return of the actual product involved, our investigation of this report is inconclusive.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.

• Brand Name: OXINIUM HD 10/12 26MM +0 EXT
• Common Device Name: PROSTHESIS, HIP, SEMI-CONSTRAINED, MRAMC/POLYMR, CMNTD OR NN-PRS, UNCMENTED
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks road; memphis TN 38116
• MDR Report Key: 8264610
• Report Number: 1020279-2019-00220
• Device Sequence Number: 16473514
• Product Code: LZO
• UDI-Device Identifier: 00885556112502
• UDI-Public: 00885556112502
• Combination Product (Y/N): N
• PMA/510(K) Number: K110101
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• 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): 04/07/2019

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: 71341910
• 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: 04/07/2019
• 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