MAUDE Adverse Event Report: SMITH & NEPHEW, INC. OXINIUM FEM HD 12/14 26 MM +0; PROSTHESIS,HIP,SEMICONSTRAIND,MTAL/CERAMC/POLYMR,CMNTDORNONPOROUS,UNCMNTD

Catalog Number	71342600
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Joint Dislocation (2374)
Date of Event	04/16/2018
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported a revision surgery was performed due to frequent dislocation.The patient had acetabular dysplasia.The surgeon thought this revision was not a product failure.No more information is available.
Additional Manufacturer Narrative
The associated tandem bp liner and oxinium femoral head were not returned for evaluation.Our investigation including a review of the manufacturing records for the listed batches did not reveal any deviation from the standard manufacturing processes.The devices were manufactured in 2017. a review of complaint history for the listed parts revealed no prior complaints for the listed failure mode with the same batch number.A clinical evaluation noted that no sufficient relevant supporting documentation was provided to perform a thorough medical investigation.However, it was communicated that the surgeon did not fault the component, as the patient had frequent dislocations secondary to acetabular dysplasia, and no further information will be provided.Therefore, the frequent dislocations secondary to the acetabular dysplasia were the contributing factors to the reported revision.No further medical assessment can be rendered at this time.Without the return of the actual product involved, our investigation of this report is inconclusive.No further investigation 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 +0
• Common Device Name: PROSTHESIS,HIP,SEMICONSTRAIND,MTAL/CERAMC/POLYMR,CMNTDORNONPOROUS,UNCMNTD
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks road; memphis TN 38116
• MDR Report Key: 7522489
• Report Number: 1020279-2018-00953
• Device Sequence Number: 11068662
• Product Code: LZO
• UDI-Device Identifier: 03596010488893
• UDI-Public: 03596010488893
• 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: 2018
• 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): 05/17/2018

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: 71342600
• Device Lot Number: 17MM07229
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 05/09/2018
• Supplement Date Received by Manufacturer: 05/09/2018
• Initial Report FDA Received Date: 05/17/2018
• Supplement Report FDA Received Date: 10/05/2018
• 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