MAUDE Adverse Event Report: SMITH & NEPHEW, INC. OXINIUM 28MM FEMORAL HEAD; PROSTHESIS, HIP, HEMI-, TRUNNION-BEARING, FEMORAL, METAL/POLYACETAL

Device Problem Unintended Movement (3026)

Patient Problems Injury (2348); Joint Dislocation (2374)

Event Date 06/25/2008

Event Type  Injury  

Event Description

It was reported that revision surgery was performed due to dislocations.Oxinium 28mm femoral head was removed.

Manufacturer Narrative

The associated complaint device was not returned.A clinical analysis indicated that intraoperatively, the acetabular cup was noted to be in excessive abduction and anteversion which appears to be the likely cause of the reported instability and recurrent dislocations.However, without the implantation and pre-revision x-rays, we are unable to determine initial implant anatomical placement.Also, without the supporting lab/pathology results, imaging, and/or the analysis of the explanted components, the root cause of the reported instability/recurrent dislocations and excessive abduction and anteversion of the cup cannot be confirmed, and it cannot be concluded that the reported 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.Should additional information be received, the complaint will be reopened.

Manufacturer Narrative

The devices, intended for use in treatment were not returned for evaluation, reporting event could not be confirmed.A clinical evaluation was conducted and confirms the root cause of the first revision is the pt¿s recurrent dislocations, excessive anteversion of the acetabular cup, and trochanteric fracture, likely be attributed to his numerous falls.The second revision reported a nonunion of the trochanteric fracture and a broken cerclage cable, as well as elevated metal ion levels and the intraoperative findings of metallosis, pseudotumor and trunnionosis, which may be consistent with findings associated with metal debris.However, the root cause of the reported clinical symptoms cannot be confirmed, or be concluded that the reported reactions/events were associated with a mal-performance of the implant.The patient impact beyond the reported pain and bilateral hip revisions cannot be determined.The patient was reported as doing well at 4 months post 2nds revision, and essentially pain-free.A complaint history review found related failures; this failure mode will be monitored for future complaints for any necessary corrective actions.A review of the risk management file and instructions for use document revealed this failure mode was previously identified.Factors and/or potential causes that could contribute to the reported event have been identified in the risk management file, as improper/ inadequate specification, clearances, mating conditions, or patient contribution.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.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: OXINIUM 28MM FEMORAL HEAD
• Type of Device: PROSTHESIS, HIP, HEMI-, TRUNNION-BEARING, FEMORAL, METAL/POLYACETAL
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks road; memphis TN 38116
• MDR Report Key: 8083844
• MDR Text Key: 127537552
• Report Number: 1020279-2018-02533
• 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: other
• Type of Report: Initial,Followup,Followup
• Report Date: 02/28/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/19/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Date Manufacturer Received: 10/29/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention