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

Device Problem Material Integrity Problem (2978)

Patient Problem Injury (2348)

Event Date 05/23/2019

Event Type  Injury  

Event Description

It was reported that a revision surgery was performed due to wear.Poly was exchanged.

Manufacturer Narrative

The associated complaint device was returned and evaluated.A lab analysis was conducted and discoloration, likely due to absorption of biological fluid, was observed on the backside of the liner.Damage/deformation was observed on the overhang of the liner; this may have been caused by impingement with the neck of the stem.Total linear penetration was estimated to be 4.52mm using silicone mold replication.No unusual wear features were observed on the acetabular liner.There have been reports of similar amounts of linear penetration for virgin, conventional uhmwpe liners in service beyond ten years.While the device was manufactured in 2006 (a portion of the lot number was visible), years of service could not be determined as the implantation date was not reported.No evidence of material or manufacturing deviations was observed in this investigation.A clinical evaluation was conducted and although wear was reportedly the cause of the revision, without the implantation date and analysis of the explanted component the definitive root cause of the reported ¿excess wear¿ cannot be determined.The x-rays show eccentric wear supporting the complaint.The patient impact beyond the reported insert exchange/revision cannot be determined.Should additional clinical information become available the clinical/medical investigation may be re-evaluated.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.No further investigation is warranted for this complaint; however we will continue to monitor for future complaints and investigate as necessary.Should additional information be received, the complaint will be reopened.

• Brand Name: HIP IMPLANT
• 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: 8704296
• MDR Text Key: 148179985
• Report Number: 1020279-2019-02300
• 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,health
• Type of Report: Initial,Followup
• Report Date: 11/18/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/17/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Date Manufacturer Received: 11/11/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention