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

Model Number N/A

Device Problems Migration or Expulsion of Device (1395); Appropriate Term/Code Not Available (3191)

Patient Problem Toxicity (2333)

Event Type  Injury  

Manufacturer Narrative

The product identification necessary to review manufacturing history was not provided.Current information is insufficient to permit a conclusion as to the cause of the event.Date explanted - remains implanted.(b)(6).Event is being reported to fda on one medwatch as the limited information available indicates that a revision procedure is (or may be) needed.Should additional information be received regarding a revision procedure, the complaint will be reassessed and further medwatch reports will be submitted, if necessary.This information was originally reported on 1825034-2015-05110 which referenced a journal article written on a study that this patient took part in.

Event Description

Information was received based on review of a journal article titled, "comparison between component designs with different femoral head size in metal-on-metal total hip arthroplasty; multicenter randomized prospective study" which aimed to investigate potential advantages of magnum group compared to conventional group in terms of range of motion, dislocation while maintaining the same function improvement and pain reduction; and to investigate metal ion release in asian population.A patient was identified in the article that underwent total hip arthroplasty on an unknown date.Subsequently, elevated metal ions, increased cup inclination angle and cup anteversion were reported.There has been no further information provided and the patient outcome is unknown.

Manufacturer Narrative

This follow-up report is being filed to relay additional information, which was unknown at the time of the initial medwatch.Review of device history records show that lot released with no recorded anomaly or deviation.There are warnings in the package insert that state that this type of event can occur: under possible adverse effects, number 15 states, "elevated metal ion levels have been reported with metal on metal articulating surfaces." this report is number 1 of 2 mdrs filed for the same event (reference 1825034-2016-00009 / 00185).

Event Description

Information was received based on review of a journal article titled, "comparison between component designs with different femoral head size in metal-on-metal total hip arthroplasty; multicenter randomized prospective study" which aimed to investigate potential advantages of magnum group compared to conventional group in terms of range of motion, dislocation while maintaining the same function improvement and pain reduction; and to investigate metal ion release in asian population.A patient was identified in the article that underwent total left hip arthroplasty on (b)(6) 2011.Subsequently, elevated metal ions, increased cup inclination angle and cup anteversion were reported.There has been no further information provided and the patient outcome is unknown.

Manufacturer Narrative

This follow-up report is being filed to relay additional information, which was unknown at the time of the initial medwatch.This report is number 1 of 3 mdrs filed for the same patient (reference 1825034-2016-03201 / 00009 / 00185).

Manufacturer Narrative

This follow-up report is being filed to relay corrected information.

Event Description

Information was received based on review of a journal article titled, "comparison between component designs with different femoral head size in metal-on-metal total hip arthroplasty; multicenter randomized prospective study" which aimed to investigate potential advantages of magnum group compared to conventional group in terms of range of motion, dislocation while maintaining the same function improvement and pain reduction; and to investigate metal ion release in asian population.A patient was identified in the article that underwent total left hip arthroplasty on (b)(6) 2011.Subsequently, pain, discomfort, elevated metal ions, increased cup inclination angle and cup anteversion were reported.There has been no further information provided and the patient outcome is unknown.

• 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: 5340538
• MDR Text Key: 34928062
• Report Number: 0001825034-2016-00009
• Device Sequence Number: 1
• Product Code: KWY
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: PK003363
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,literature
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 08/22/2016

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 Expiration Date: 08/31/2016
• Device Model Number: N/A
• Device Catalogue Number: 15-103682
• Device Lot Number: 969620
• Other Device ID Number: N/A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/15/2015
• Initial Date FDA Received: 01/04/2016
• Supplement Dates Manufacturer Received: Not provided; Not provided; Not provided
• Supplement Dates FDA Received: 01/15/2016; 08/19/2016; 09/21/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/28/2006
• 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: 75 YR
• Patient Weight: 58