MAUDE Adverse Event Report: SMITH & NEPHEW, INC. OXINIUM FEM HD 12/14 28MM -3; PROSTH, HIP, SEMI-CONST, MET/CERAM/POLY, CEMENT OR NON-POROUS, UNCEMENT

Catalog Number	71342803
Medical Device Problem Code	Loose or Intermittent Connection (1371)
Health Effect - Clinical Code	Injury (2348)
Date of Event	01/10/2019
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that a revision of total hip was performed due to instability.Further information is unknown yet.
Additional Manufacturer Narrative
The associated oxinium head was not returned for evaluation.Therefore, a product analysis could not be conducted.After repeated requests, smith and nephew has been unable to obtain device details.As device details were not made available, device history record review cannot be completed.Complaint history review could not be performed with any accuracy due to lack of product information.A clinical evaluation noted that no clinical relevant supporting documentation was provided; therefore, a thorough medical investigation could not be performed.Without the return of the actual product involved, our investigation of this report is inconclusive.No further investigation is warranted for this complaint; however we will continue to monitor for future complaints and investigate as necessary.Should the device or additional information be received, the complaint will be reopened.

• Brand Name: OXINIUM FEM HD 12/14 28MM -3
• Common Device Name: PROSTH, HIP, SEMI-CONST, MET/CERAM/POLY, CEMENT OR NON-POROUS, UNCEMENT
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks road; memphis TN 38116
• MDR Report Key: 8299097
• Report Number: 1020279-2019-00389
• Device Sequence Number: 13941378
• Product Code: LZO
• UDI-Device Identifier: 03596010474155
• UDI-Public: 03596010474155
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K021673
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Explanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 06/10/2019

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: 71342803
• Initial Date Received by Manufacturer: 01/10/2019
• Supplement Date Received by Manufacturer: 01/10/2019
• Initial Report FDA Received Date: 02/01/2019
• Supplement Report FDA Received Date: 06/10/2019
• 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