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

Catalog Number UNK HIP FEMORAL HEAD

Device Problems Fracture (1260); Noise, Audible (3273)

Patient Problems Foreign Body Reaction (1868); Hypersensitivity/Allergic reaction (1907); Necrosis (1971); Pain (1994); Limited Mobility Of The Implanted Joint (2671); No Code Available (3191)

Event Type  Injury  

Manufacturer Narrative

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

Event Description

"literature article entitled, ¿histologic and ultrastructural analysis in a case of massive failure of zirconia ball head¿ by g.Maccauro, et al, published by hip international (2002), vol.12, no.4, pp.388-393, was reviewed.The in vivo histological and ultrastructural analysis of periprosthetic tissue collected at time of revision surgery for failure of a 28 mm yttria-tetragonal zirconium oxide polycrystal (ytzp) ball head, 2 years after implantation is reported.Depuy products: geomodular medinov cementless stem, 28-mm ceramic/zirconia femoral head, duraloc cup, and polyethylene liner.In 1999, a (b)(6) male was implanted with a tha to treat advanced coxarthrosis of the left hip.In 2000, depuy advised the patient to have the head revised because the implant was at risk for fracture, but he did not comply.In (b)(6) 2002, the patient presented with pain, clicking, and decreased range of motion of the operative hip that began 2 months previously.Radiologic studies revealed a fracture of the femoral head.Intraoperatively, the surgeons found a fractured femoral head, periacetabular metallosis, soft tissue necrosis, and corrosion of the femoral taper evidenced by black metal debris.There was no damage to the cup or polyethylene liner, but the surgeons explanted all components and revised to competitor products.Histologic analysis of the excised tissue identified polyethylene, zirconia, and metal debris in the tissues as well as inflammatory markers indicative of foreign body reaction.The authors note that the polyethylene debris was attributed to the fracture of the femoral head.The foreign body reaction and corrosion of the femoral stem was attributed to the fracture of the femoral head and the 2-month time period between head fracture and surgical intervention.Captured in this complaint: ceramic/zirconia femoral head and geomodular femoral stem.There were no reported product problems with the cup or liner, therefore the cup and liner are not reportable.The foreign body reaction, pain, squeaking, soft tissue necrosis, and decreased joint range of motion are attributed to the fracture of the ceramic femoral head and corrosion of the stem taper.".

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 code(s) was not provided.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.Corrective action was not indicated.If information is obtained that was not available for the initial medwatch, a follow-up medwatch, a follow-up medwatch will be filed as appropriate.

• 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
• Manufacturer (Section G): JTE WARSAW MFG SITE; 700 orthopaedic drive; warsaw IN 46582
• Manufacturer Contact: kara ditty-bovard ; 1210 ward avenue; west chester, IN 19380-0988 ; 6103142063
• MDR Report Key: 9348136
• MDR Text Key: 184992630
• Report Number: 1818910-2019-115484
• Device Sequence Number: 1
• Product Code: KXA
• Combination Product (y/n): N
• Reporter Country Code: IT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,literature
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 10/30/2019

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?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: UNK HIP FEMORAL HEAD
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 10/30/2019
• Initial Date FDA Received: 11/20/2019
• Supplement Dates Manufacturer Received: 11/21/2019
• Supplement Dates FDA Received: 11/29/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention