MAUDE Adverse Event Report: SMITH & NEPHEW, INC. OXINIUM FEM HD 12/14 26 MM +8; PROSTHESIS HIP SMICONSTRAIND METALCRAMICPOLYMR CMNTD OR NONPOROUS UNCMNTD

Catalog Number	71342608
Medical Device Problem Code	Device Dislodged or Dislocated (2923)
Health Effect - Clinical Code	Joint Dislocation (2374)
Date of Event	07/12/2019
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that a revision surgery was performed due to a dislocation.
Additional Manufacturer Narrative
The associated complaint devices were not returned.The clinical/medical team concluded, no clinically relevant supporting documentation was provided; therefore, a thorough medical investigation could not be performed.Should patient specific clinical documentation become available in the future, the clinical/medical task may be re-evaluated.Of note, it was communicated that the surgeon does not fault the device.A review of the production documentation for the corresponding products did not reveal any deviation from the standard manufacturing processes.A review of complaint history for the listed parts revealed prior complaints for the listed batches.Without the actual device involved our investigation cannot proceed.If the device or new information is received in the future, the complaints can be re-opened.No further actions are being taken at this time.We consider this investigation closed.

• Brand Name: OXINIUM FEM HD 12/14 26 MM +8
• Common Device Name: PROSTHESIS HIP SMICONSTRAIND METALCRAMICPOLYMR CMNTD OR NONPOROUS UNCMNTD
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks road; memphis TN 38116
• MDR Report Key: 8884442
• Report Number: 1020279-2019-03025
• Device Sequence Number: 19515653
• Product Code: LZO
• UDI-Device Identifier: 03596010488916
• UDI-Public: 03596010488916
• 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: 2019
• Device Explanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 12/11/2019

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: 71342608
• Device Lot Number: 18GM12020
• Initial Date Received by Manufacturer: 07/17/2019
• Supplement Date Received by Manufacturer: 07/17/2019
• Initial Report FDA Received Date: 08/12/2019
• Supplement Report FDA Received Date: 12/11/2019
• 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