MAUDE Adverse Event Report: SMITH & NEPHEW, INC. UNKNOWN SMF STEM; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, CEMENTED

Device Problem Loose or Intermittent Connection (1371)

Patient Problem Injury (2348)

Event Type  Injury  

Event Description

"radiographic analysis of stability after implantation of three different cementless short femoral stems ¿ five year follow-up".Author: wieslaw lachowicz et al.January 2019; 161-165.In this study, 180 patients divided in 3 groups were analized, 60 patients each; 60 patients bearing smf femoral stem and the other 2 groups bearing competitor devices (corin and jri).It was reported that 6 cases required revision surgery due to loosening in the smf group.

Manufacturer Narrative

It was reported a literature review that patient required a revision surgery due to loosening.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.Based on this investigation, the need for corrective action is not indicated.Some potential causes could include but are not limited to fit/sizing, traumatic injury, abnormal motion over time, poor bone ingrowth or osteolysis (patient medical history).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: UNKNOWN SMF STEM
• Type of Device: PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, CEMENTED
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks road; memphis TN 38116
• MDR Report Key: 10024909
• MDR Text Key: 189865112
• Report Number: 1020279-2020-01452
• Device Sequence Number: 1
• Product Code: JDI
• 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: 07/24/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/05/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Date Manufacturer Received: 07/23/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention