MAUDE Adverse Event Report: BIOMET ORTHOPEDICS M2A-T UNIV 2-HOLE SHL SZ 41/52; PROSTHESIS, HIP

Model Number N/A

Device Problem Material Erosion (1214)

Patient Problem Hip Fracture (2349)

Event Date 08/15/2014

Event Type  Injury  

Manufacturer Narrative

Current information is insufficient to permit a conclusion as to the cause of the event.Review of device history records show that lot released with no recorded anomaly or deviation.The following could not be completed due to the part/lot information could be: lot number - 756970.Expiration date - feb 28, 2016.Manufacture date ¿ feb 3, 2006.Or the part/lot information could be: lot number - 839970.Expiration date - apr 30, 2015.Manufacture date ¿ apr 4, 2005.There are warnings in the package insert that state that this type of event can occur: under possible adverse effects, number 14 states, ¿intraoperative or postoperative bone fracture and/or postoperative pain.¿ this report is number 5 of 6 mdrs filed for the same event (reference 1825034-2014-07630 / 2014-07631 / 2015-04975 / 2014-07632 / 2016-01385 / 2016-01386).Product location unknown.

Event Description

It was reported that patient underwent bilateral total hip arthroplasties on (b)(6) 2006.Subsequently, the left hip was revised on (b)(6) 2007 due to an unknown reason.The modular head and femoral stem were removed and replaced.It was further reported that a second left hip revision procedure was performed on (b)(6) 2014 in which the modular head, acetabular cup and acetabular liner were removed and replaced due to elevated metal ion levels.During the revision the patient's pelvis was fractured, which resulted in the implantation of a tricortical bone wedge.This caused a delay of approximately 60 minutes.Subsequently, a third revision procedure was performed on (b)(6) 2014 due to the fracture in the patient's pelvis not healing.During the revision, the modular head, acetabular cup and liner were removed and replaced with a biomet head and competitor cup and liner.Additional information received from patient's legal counsel reported the patient's right hip was revised on (b)(6) 2015 due to pain.Elevated metal ion levels and metallosis were allegedly noted during the procedure.Subsequently, the patient dislocated on (b)(6) 2015.It is unknown how this event was resolved.Additional information received in operative report noted that during the (b)(6) 2014 revision, metal debris with large cyst formation was noted.Operative report for the revision on (b)(6) 2015 noted significant fluid collection and metallosis.The procedure was completed with competitor product.Additional information received in operative report noted that the revision procedure on (b)(6) 2007 occurred due to pain and loosening of the femoral component.Additionally, during the (b)(6) 2014 revision procedure, it was noted that no signs of metallosis or infection were found.Mri showed signs of excess fluid.

• Brand Name: M2A-T UNIV 2-HOLE SHL SZ 41/52
• 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: 5599394
• MDR Text Key: 43376653
• Report Number: 0001825034-2016-01385
• Device Sequence Number: 1
• Product Code: KWY
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: PK003363
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 03/08/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/22/2016
• 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: 15-103682
• Other Device ID Number: N/A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/08/2016
• 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): Required Intervention
• Patient Age: 52 YR