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

Device Problems Break (1069); Noise, Audible (3273)

Patient Problem Limited Mobility Of The Implanted Joint (2671)

Event Date 01/01/1901

Event Type  Injury  

Event Description

Proven abrasions of the ceramic insert and breakage of the ceramic ball head with indication for surgery.Patient felt scrubbing in the left hip since 1-2 years and after climbing some stairs in the mid of (b)(6) 2018 progressive squeaking and limited mobility.

Manufacturer Narrative

The associated complaint device was not returned for evaluation.A clinical evaluation noted that per the imaging and intraoperative findings, the root cause of the revision was the ceramic head fracture.However, given the pathology results and length of time the patient was reportedly symptomatic, the root cause of the ceramic head fracture/decentration cannot be concluded although the approximated 23 years in vivo and an unrealized impact are likely contributing factors.The patient impact beyond the reported symptoms and hip revision cannot be determined.All documents provided as of this date have been reviewed and considered and unless noted do not contribute to the clinical investigation.No further medical assessment is warranted at this time.Without the return of the actual product involved and no product information available, 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.

Manufacturer Narrative

The associated complaint device was not returned for evaluation.A clinical evaluation noted that per the imaging and intraoperative findings, the root cause of the revision was the ceramic head fracture.However, given the pathology results and length of time the patient was reportedly symptomatic, the root cause of the ceramic head fracture/ decentration cannot be concluded although the approximated 23 years in vivo and an unrealized impact are likely contributing factors.The patient impact beyond the reported symptoms and hip revision cannot be determined.All documents provided as of this date have been reviewed and considered and unless noted do not contribute to the clinical investigation.No further medical assessment is warranted at this time.Without the return of the actual product involved and no product information available, 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.

• 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: 7563997
• MDR Text Key: 109879946
• Report Number: 1020279-2018-01030
• 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,foreig
• Type of Report: Initial,Followup,Followup
• Report Date: 09/17/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/02/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Emergency Medical Technician
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 05/08/2018
• Patient Sequence Number: 1
• Treatment: UNKNOWN KNEE IMPLANT/UNKNOWN LOT NUMBER
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 81 YR