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

Catalog Number UNK HIP FEMORAL HEAD

Device Problem Naturally Worn (2988)

Patient Problems Fatigue (1849); Foreign Body Reaction (1868); Hypersensitivity/Allergic reaction (1907); Pain (1994); Loss of Range of Motion (2032); Osteolysis (2377); Ambulation Difficulties (2544); Unspecified Tissue Injury (4559); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Date 06/07/2019

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.

Event Description

Literature article abstract entitled, ¿total hip replacement failure due to adverse local tissue reaction from both ceramic abrasive wear and trunnion corrosion¿ by william christian thomas, md and hernan a.Prieto, md, published by arthroplasty today (2019), vol.5, pp.384-388, was reviewed.This article is a case report presenting a unique case of catastrophic metallosis and elevated blood metal ions due to dual interface failure associated with abrasive third-body wear from prior ceramic fracture at the level of the metal-on-polyethylene (mop) bearing surface, as well as trunnion corrosion from a prior ceramic head fracture with subsequent revision to a metal femoral head.Revision 1: patient received a right hip primary tha in 2005 consisting of pinnacle cup, uncemented corail stem, and ceramic on ceramic articulating surfaces.The patient received a revision in 2009 to treat a fracture of the ceramic femoral head.The surgeon reports the liner was impossible to remove due to the fracture of the femoral head, therefore the pinnacle cup and ceramic liner were revised with a competitor cup and competitor polyethylene liner in addition to the depuy articul/eze cocr femoral head.The femoral stem was well-fixed and left in situ.The authors provide no additional information regarding this procedure.Revision 2: a (b)(6) year-old female patient received a second right hip revision to treat pain, weakness, limping, femoral and acetabular osteolysis, and a large pseudotumor.Preoperative blood work identified elevated cr at 166.6 ppb and co at 115.5 ppb, with no evidence of infection.Upon entering the joint, the surgeons identified massive armd, with dark stained synovial fluid and periarticular tissue necrosis.The surgeons resected a pseudotumor measuring 10x6x4 cm and tissue analysis of the pseudotumor identified significant metallosis.The femoral stem was loose secondary to osteolysis and easily removed.The surgeons note there was severe trunnion damage with corrosion and scratching.The competitor cup was well-fixed and retained.The competitor liner had extensive third body wear due to fragments of the previously fractured ceramic head embedded into it, causing wear and abrasion on the articul/eze femoral head.The surgeons note there was acetabular osteolysis and dark stained tissue on the backside of the competitor cup.The patient was revised with competitor products.The procedure was completed without complications.The authors suspect the wear of the femoral head to ceramic fragments from the previous femoral head fracture that are embedded into the polyethylene.

Manufacturer Narrative

Product complaint # (b)(4).Investigation summary: no device associated with this report was received for examination.The x-ray images depict the patient post revision and so do not offer any information about the revised devices.A device photograph of the revised femoral head offers no information to aid in this investigation.In the view provided it is not possible to conclusively identify the head as being of depuy manufacture.A root cause cannot be determined using the provided images.The information received will be retained for potential series investigations if triggered by trend analysis or other events within the quality system.Depuy considers the investigation closed.Should additional information be received, the information will be reviewed, and the investigation will be re-opened as necessary.Device history lot: a device history record (dhr) review, was not possible because the required lot code(s) was not provided.

• 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: 10957692
• MDR Text Key: 219981390
• Report Number: 1818910-2020-26291
• Device Sequence Number: 1
• Product Code: KWA
• Combination Product (y/n): N
• 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: 11/23/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/07/2020
• 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
• Date Manufacturer Received: 01/12/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 59 YR