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

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

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

Event Date 01/01/2014

Event Type  Injury  

Event Description

Literature case "risk factors for periprosthetic femur fracture and influence of femoral fixation using the mini-anterolateral approach in primary total hip arthroplasty".Author: carl l.Herndon, md et al., the journal of arthroplasty.There were 684 primary thas in this study, 57 (8.3%) pffs (periprosthetic femur fracture) occurred.It was documented on the paper that there were 6 pffs in patients with smith & nephew anthology femoral stem.

Manufacturer Narrative

The affected complaint device, used in treatment, was not returned for evaluation.Therefore, a product analysis could not be performed.There is no information that would suggest the device failed to meet specifications.According to clinical/medical investigation, 6 acute post-op periprosthetic femur fractures (pff) occurred in the patients with a s+n anthology femoral stem during the primary tha via al approach study.Per the article, the well-described potential complication (pff) with the al approach has similar risks in the 3 months immediately post-op as compared to other approaches.Per correspondence, ¿each of these cases were individual fractures and do not represent a flaw in design or manufacturing¿.Patient specific clinically relevant documentation was not provided.The root cause and/or patient outcome beyond that which was documented in the article cannot be confirmed nor concluded; therefore, no further medical assessment is warranted at this time.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.The potential probable causes for this event could include but not limited to a user or procedural error.Based on this investigation, the need for corrective action is not indicated.The potential probable causes for this event could include but not limited to a patient condition, user or procedural error.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.We consider this investigation closed.

• Brand Name: ANTHOLOGY HIP IMPL
• Type of Device: PROSTHESIS, HIP, HEMI-, TRUNNION-BEARING, FEMORAL, METAL/POLYACETAL
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks rd.; memphis TN 38116
• MDR Report Key: 10137519
• MDR Text Key: 194613241
• Report Number: 1020279-2020-02289
• Device Sequence Number: 1
• Product Code: JDH
• Combination Product (y/n): N
• PMA/PMN Number: N/A
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,literatur
• Type of Report: Initial,Followup
• Report Date: 05/04/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/10/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 04/15/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention