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

Device Problem Insufficient Information (3190)

Patient Problems Bone Fracture(s) (1870); Injury (2348)

Event Type  Injury  

Event Description

In a scientific publication, author: lin longquan, "periprosthetic fracture in primary total hip arthroplasty for bioprosthesis: incidence, treatment and prognosis" it was reported that 20 patients presented several types of fractures including: type a1(5 patients), type b1(3 patients), type a2l(6 patients) and type a2g(6 patients), there was no treatment reported for these cases.In addition, there was 13 cases of type b2 fracture that required touch type weight loading for 6-8 weeks in order to treat the fractures.10 cases required cerclage wires fixation at proximal end of the femur due to type a3l and type 13g fractures.There is no information regarding to the implanted devices, the only available information states that the overall use of the devices was 501 cases with s+n products and 122 cases with competitor devices.

Manufacturer Narrative

It was reported from a literature review of the paper "periprosthetic fracture in primary total hip arthroplasty for bioprosthesis: incidence, treatment and prognosis" from author lin longquan, that twenty patients presented several types of fractures.The affected complaint device, used in treatment, was not returned for evaluation.Therefore a product analysis could not be performed.As device information was not made available, device history record and complaint history review cannot be completed.There is no information that would suggest the device failed to meet specifications.A relationship, if any, between the device and the reported incident could not be corroborated.No medical documents were received for investigation.Therefore no medical assessment can be performed at this time.Some potential causes of the reported event could include but are not limited to traumatic injury or patient conditions.Based on this investigation, the need for corrective action is not indicated.Without the return of the actual product involved and no patient medical records 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.

• 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: 9771142
• MDR Text Key: 181471328
• Report Number: 1020279-2020-00735
• 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: foreign,health professional,l
• Type of Report: Initial,Followup
• Report Date: 10/14/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/28/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Date Manufacturer Received: 10/02/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention