MAUDE Adverse Event Report: BIOMET ORTHOPEDICS UNKNOWN HIP; PROSTHESIS, HIP

Model Number N/A

Device Problem Migration or Expulsion of Device (1395)

Patient Problem Death (1802)

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 following sections could not be completed with the limited information provided.Date of event - unknown; device code - unknown; expiration date - unknown; date implanted - unknown; date explanted - unknown.(b)(6).

Event Description

Information was received based on the review of the journal article, "trilogy-constrained acetabular component for recurrent dislocation." this is a retrospective review of all patients treated with a trilogy constrained liner in the hip clinic (b)(6) hospital, (b)(6), in the period 2005¿2009.The cohort comprised 38 patients all treated with a constrained acetabular insert because of recurrent dislocations (average 4.6 dislocations; range (1¿10), one was treated twice.Three patients were identified by searching the electronic database for all revision hip arthroplasties.All these patients were reviewed and the ones who were revised using a constrained liner were included in the present study.Of these patients, a number had to be excluded.Five patients were fitted with another brand of constrained liner and one emigrated and was lost to followup.Thirty two patients received a trilogy- or trilogy-longevity-constrained acetabular liner for recurrent dislocations after total hip replacement all with bimetric stems.Legacy biomet products may have been implanted in patients who experienced the following adverse events: seven (7) patients died due to unknown reasons.One (1) patient experienced progressing radiolucent lines around the femoral component.One (1) patient was revised on an unknown date due to stem loosening.The constrained liner has in the present material been used only as a salvage procedure in a population of patients with recurrent dislocations, which might explain the rather high rate of failure.Furthermore, patients with conditions predisposing to hip-dislocation also seemed to be at a higher risk for subsequent failure of the constrained liner.However, 88% of the patients had no further dislocations.

• Brand Name: UNKNOWN HIP
• Type of Device: PROSTHESIS, HIP
• 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: 5490184
• MDR Text Key: 40018890
• Report Number: 0001825034-2016-00850
• Device Sequence Number: 1
• Product Code: LWJ
• Combination Product (y/n): N
• Reporter Country Code: DA
• PMA/PMN Number: PUNKNOWN
• 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: 03/02/2016

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
• Device Model Number: N/A
• Device Catalogue Number: UNKNOWN
• Device Lot Number: UNKNOWN
• Other Device ID Number: N/A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/02/2016
• Initial Date FDA Received: 03/09/2016
• 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): Hospitalization; Required Intervention