MAUDE Adverse Event Report: SMITH & NEPHEW, INC. OXINIUM FEM HD 12/14 36 MM L/+8; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, CEMENTED

Catalog Number	71343608
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	Joint Dislocation (2374)
Date of Event	07/08/2019
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that right hip revision surgery was performed due to recurrent dislocations.
Additional Manufacturer Narrative
The associated complaint devices were returned and evaluated.The lab analysis for the femoral, right tibial articulating insert, and left tibial articulating insert scratches on the femoral condyle articular surfaces that are along the radius are likely the result of articulation of the knee.The source of other scratches could not be determined from the information provided.No material or manufacturing deviations were observed in the course of this investigation.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 part revealed no prior complaints for the listed batch/failure mode.The clinical/medical team concluded, it was communicated that clinically relevant documentation would not be available for inclusion in a medical assessment.It was reported that a previous spinal fusion was believed to possibly have contributed to the dislocation and subsequent revision.Based on the lab analysis, the explanted liner identified ¿deformation¿ which ¿is a consistent finding when there is impingement with the femoral component neck.The visual evidence of neck impingement suggest an alignment issue may have been one contributing to the cause for recurring dislocations¿.No further clinically relevant information was provided for inclusion in the medical investigation.The patient impact beyond the reported recurrent dislocations and subsequent revision could not be determined.No further medical assessment can be rendered at this time.At this time, we have no reason to suspect that the product failed to meet any product specifications at the time of manufacture.Based on this investigation, the need for corrective action is not indicated.Should additional information be received, the complaint will be reopened.

• Brand Name: OXINIUM FEM HD 12/14 36 MM L/+8
• Common Device Name: PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, CEMENTED
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks road; memphis TN 38116
• MDR Report Key: 8849252
• Report Number: 1020279-2019-02882
• Device Sequence Number: 371764
• Product Code: JDI
• UDI-Device Identifier: 03596010477293
• UDI-Public: 03596010477293
• Combination Product (Y/N): N
• Initial Reporter Country: SF
• PMA/510(K) Number: K022958
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2013
• Device Explanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: foreign,health professional,u
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 11/26/2019

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 Expiration Date: 07/10/2023
• Device Catalogue Number: 71343608
• Device Lot Number: 13GM07987
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/05/2019
• Initial Date Received by Manufacturer: 07/08/2019
• Supplement Date Received by Manufacturer: 07/08/2019; 07/08/2019
• Initial Report FDA Received Date: 08/01/2019
• Supplement Report FDA Received Date: 08/12/2019; 11/26/2019
• 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
• Patient Age: 62 YR