MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US UNKNOWN HIP FEMORAL HEAD

Catalog Number UNK HIP FEMORAL HEAD

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

Patient Problems Ossification (1428); Fall (1848); Pain (1994)

Event Date 08/24/2020

Event Type  Injury  

Manufacturer Narrative

Product complaint #: (b)(4).If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

Event Description

An article/literature was received entitled "multiple failures of internal fixation for treatment of periprosthetic femoral refracture: a case report and literature review".Literature article entitled ""multiple failures of internal fixation for treatment of periprosthetic femoral refracture: a case report and literature review"" written by jing shen, yang zhang, guisong yu and weifeng ji.Published by journal of international medical research published online/accepted by publisher 24 aug 2020 was reviewed.The article's purpose was to follow the case study of a (b)(6) year old man who developed both aseptic necrosis of the femoral head and hip arthritis and therefore agreed to undergo tha.The prosthetic femoral stem was a corail femoral stem.The patient suffered a fall and resulting femoral bone fracture 2-months post-primary.The patient was treated by an open reduction and internal fixation with the use of a locking plate with cable system of an unknown manufacturer 3 days after the fracture.A second orif had to be performed involving multiple cables of an unknown manufacturer 2 days after the first orif due to pain and failure of the cable system.A third orif was performed 3 months following the second orif due to the internal plate fracture of an unknown manufacturer's plate.Ultimately, it was discovered the internal failure had been caused by proximal cable cut-out in which the cable had cut into the bone and stopped because the stem was metal on the medial side.Additionally, malunion due to failed plates and cables and hypertrophic osteogenesis were found at the fracture site.There is no evidence of revision involving the corail femoral stem implanted during the primary operation.There was no indicated product failure involving the femoral stem.The second and third orifs were due to the failure of the unknown cable and plate system.After the third orif durable hip function was achieved.X-ray and ct images can be found on pages 2, 3, 4, and 5 of the literature article.Depuy products with known adverse event(s): corail femoral stem.Adverse events: post-operative femoral bone fracture treated by orif.Two additional orifs caused by fractures of unknown manufacturer plate and pain.The patient also experienced the following patient harms: pain, fall, weakness, and hypertrophic osteogenesis.

Manufacturer Narrative

Product complaint # (b)(4).Investigation summary: no device associated with this report was received for examination.A worldwide lot specific complaint database search, or device history record (dhr) review, was not possible because the required lot number was not provided.Based on previous investigations, this complication of joint replacement is unlikely to have been the result of a device failing to meet required specifications.The information received will be retained for potential series investigations if triggered by trend analysis, post market surveillance, or other events within the quality system.Device history lot: the product investigation found no evidence suspecting an error in the manufacturing or material that would be a contributing factor in the reported allegation(s).Where the lot code was provided, a manufacturing records evaluation (mre) was not performed.

• Brand Name: UNKNOWN HIP FEMORAL HEAD
• Type of Device: HIP FEMORAL HEAD
• Manufacturer (Section D): DEPUY ORTHOPAEDICS INC US; 700 orthopaedic drive; warsaw IN 46581 0988
• MDR Report Key: 12370212
• MDR Text Key: 268225940
• Report Number: 1818910-2021-18709
• 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: 08/07/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: UNK HIP FEMORAL HEAD
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 08/07/2021
• Initial Date FDA Received: 08/26/2021
• Supplement Dates Manufacturer Received: 10/20/2021
• Supplement Dates FDA Received: 10/21/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention