MAUDE Adverse Event Report: SMITH AND NEPHEW INC 36 +0 OXINIUM FEMORAL HEAD; PROSTHESIS, HIP, HEMI-, TRUNNION-BEARING, FEMORAL, METAL/POLYACETAL

Device Problem Loosening of Implant Not Related to Bone-Ingrowth (4002)

Patient Problem No Information (3190)

Event Date 02/16/2017

Event Type  Injury  

Event Description

It was reported that a revision surgery was performed.The 36 +0 oxinium femoral head was exchanged due to aseptic loosening.

Manufacturer Narrative

The associated complaint devices were not returned.A clinical evaluation was conducted and it was reported the cup was in a horizontal position, but no x-rays were provided for review to assess if this was a change in position or the position the cup was implanted.The patient was reported to have had prolonged steroid treatment which led to multifocal avn; it cannot be ruled out that this may have contributed to the cup possibly changing position post implantation.The reported malposition of the acetabular component cannot be ruled out as contributing factor to the reported pain and ¿metallosis¿ noted intraoperatively.Without the supporting lab/pathology results, imaging, and/or the analysis of the explanted components, the root cause of the reported pain, aseptic loosening and malposition of the cup, and ¿metallosis¿ encountered intraoperatively cannot be confirmed and it cannot be concluded that the reported clinical reactions/events were associated with a mal-performance of the implant.The patient impact beyond the pain, revision, and expected transient post-op convalescence period cannot be determined.No further clinical assessment is warranted at this time.Without the actual product involved and/or device information, our investigation cannot proceed.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.

• Brand Name: 36 +0 OXINIUM FEMORAL HEAD
• Type of Device: PROSTHESIS, HIP, HEMI-, TRUNNION-BEARING, FEMORAL, METAL/POLYACETAL
• Manufacturer (Section D): SMITH AND NEPHEW INC; 1450 brooks road; memphis TN 38116
• MDR Report Key: 8000079
• MDR Text Key: 124839042
• Report Number: 1020279-2018-02266
• Device Sequence Number: 1
• Product Code: JDH
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,other
• Type of Report: Initial,Followup
• Report Date: 05/08/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/24/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 09/25/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 42 YR