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

Catalog Number UNK HIP FEMORAL HEAD

Device Problems Corroded (1131); Device Dislodged or Dislocated (2923); Naturally Worn (2988)

Patient Problems Foreign Body Reaction (1868); Pain (1994); Loss of Range of Motion (2032); 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.

Event Description

Literature article entitled, ¿cutaneous manifestation of metallosis on a metal-on-metal total hip arthroplasty after acetabular liner dissociation¿ by s.Sporer and p.Chalmers published in the journal of arthroplasty (2012) vol.27 no.8, pp.13-16 was reviewed for mdr reportability.The article discusses a case study of a (b)(6) year old woman with advanced stage osteoarthritis requiring surgical revision due to cup dissociation and resultant corrosion of the neck of the femoral component and dislodged acetabular component following primary metal-on-metal (mom) tha with a pinnacle 54 mm cup, ultamet mom insert, a modular cocr femoral head, and a summit tapered stem, and screws (depuy).The patient presents with cutaneous manifestation of extensive metallosis, pain, audible grinding noise, and decreased rom requiring confinement to a wheelchair.Preoperative a/p radiographic scans revealed notching at the inferior aspect of the neck of the femoral component and metal liner dissociation.Surgical revision identified extensive soft tissue and deep fascia metallosis with periarticular surfaces stained black and the acetabular modular metal insert dislodged into a retroverted position with the edge of the liner causing impingement and eroding through the neck of the femoral component.Additionally, there is visible, severe burnishing of the superolateral inner lining of the cup with damage to the locking mechanism.Removal of the femoral stem required trochanteric osteotomy was required to remove the osseointegrated summit femoral stem.The depuy implants were exchanged zimmer tha products, including a longevity polyethylene liner, 58 mm trabecular metal acetabular shell, size 14 verys 6.5 mm femoral stem, and a 35mm neck/40mm modular femoral head.Three-year post-revision follow-up reveals no patient complications, although the patient¿s peri-incisional black cutaneous discoloration remains unchanged.Adverse event(s) related to product(s): dissociation of the mom liner (dislodged or dislocated).Adverse reaction to metal debris.Implant noise (noise, audible).Implant corrosion- taper.Implant corrosion- cup & liner.Permanent skin discoloration.Impingement on the neck of the femoral component.Intraoperative finding(s): metal debris and black staining of cutaneous and periarticular tissues.Implant dissociation- liner.Impingement of femoral neck.Corrosion of head/neck junction.Corrosion of inner cup lining.Implant dissociation- locking mechanism.Patient(s) reported harm(s) prior to procedure: joint rom decreased.Pain.Local reaction.

Manufacturer Narrative

(b)(4).

• 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): DEPUY ORTHOPAEDICS, INC. 1818910; 700 orthopaedic dr.; warsaw IN 46581 0988
• Manufacturer Contact: kara ditty-bovard ; 1210 ward avenue; west chester, PA 19380-0988 ; 6103142063
• MDR Report Key: 8862413
• MDR Text Key: 153716351
• Report Number: 1818910-2019-100123
• Device Sequence Number: 1
• Product Code: KWY
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,literatur
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 07/29/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/05/2019
• 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?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/23/2019
• 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