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

Lot Number UNKNOWN

Device Problem Insufficient Information (3190)

Patient Problem Bone Fracture(s) (1870)

Event Date 01/01/1901

Event Type  Injury  

Event Description

Literature case "early to mid-term outcome of oxinium on verilast highly cross-linked polyethylene bearing surface in uncemented total hip arthroplasty".Author: anshul s sobti et al., hip international, 2019.In this study, it was reported 5- to 10-year clinical and radiological outcomes of a series of uncemented oxinium on verilast (highly cross-linked polyethylene liners) total hip replacements (thas) using the anthology stem and r3/reflection cup system.It was documented on the paper that two peri-prosthetic fractures occurred and were treated with open reduction and fixation, both healed well with excellent outcomes.

Manufacturer Narrative

B3 date of event corrected to unknown.B4 description corrected to singular event, not two.It was reported from a literature review that the patient had peri-prosthetic fracture.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 patient conditions or user/procedural technique.It was reported that the issue was treated with open reduction and fixation, and it healed well with excellent outcomes.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.

Event Description

"early to mid-term outcome of oxinium on verilast highly cross-linked polyethylene bearing surface in uncemented total hip arthroplasty".Author: anshul s sobti et al., hip international, 2019.In this study, it was reported 5- to 10-year clinical and radiological outcomes of a series of uncemented oxinium on verilast (highly cross-linked polyethylene liners) total hip replacements (thas) using the anthology stem and r3/reflection cup system.It was documented on the paper that a peri-prosthetic fractures occurred and was treated with open reduction and fixation.Case healed well with excellent outcome.

• Brand Name: UNKNOWN ANTHOLOGY HIP IMPLANT
• 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: 10137783
• MDR Text Key: 194622764
• Report Number: 1020279-2020-02292
• 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
• Report Date: 09/22/2020

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
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 09/15/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention