MAUDE Adverse Event Report: BIOMET ORTHOPEDICS UNKNOWN MALLORY-HEAD ACETABULAR COMPONENT; HIP PROSTHESIS

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problem Ossification (1428)

Event Type  Injury  

Manufacturer Narrative

Current information is insufficient to permit conclusions as to the cause of the events.Event details and product identification was not provided for the patient mentioned in the journal article.The article was written by weird p.Zijlstra, inge van den akker-scheek, mark j.M.Zee and jos j.A.M.Van raay.

Event Description

Information was received based on review of a journal article titled, "no clinical difference between large metal-on-metal total hip arthroplasty and 28-mm-head total hip arthroplasty?" which aimed to test the claim of greater range of motion (rom) with large femoral head metal-on-metal total hip arthroplasty using mmagnum and mallory-head acetabular components with arcom liners manufactured by biomet; and to investigate whether large femoral head metal-on-metal total hip total arthroplasty has greater rom at one year postoperatively compared to 28-mm metal-on-polyethylene.Two patients were identified in the article that underwent hip arthroplasties on unknown dates.Patient follow-up results provided indicate that the patients experienced grade 2 periarticular ossification post-operatively using metal-on-polyethylene.There has been no further information provided and the patient outcome is unknown.

• Brand Name: UNKNOWN MALLORY-HEAD ACETABULAR COMPONENT
• Type of Device: HIP PROSTHESIS
• Manufacturer (Section D): BIOMET ORTHOPEDICS; 56 e. bell drive; warsaw IN 46582
• Manufacturer (Section G): BIOMET ORTHOPEDICS; 56 e. bell drive; warsaw IN 46582
• Manufacturer Contact: megan haas ; 56 e. bell drive; warsaw, IN 46582 ; 5743726700
• MDR Report Key: 6090489
• MDR Text Key: 59553282
• Report Number: 0001825034-2016-04602
• Device Sequence Number: 1
• Product Code: JDG
• Combination Product (y/n): N
• Reporter Country Code: NL
• PMA/PMN Number: PN/A
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,literature
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 10/11/2016

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: Physician
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 10/11/2016
• Initial Date FDA Received: 11/09/2016
• 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
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Patient Outcome(s): Other