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); Malposition of Device (2616)

Patient Problems Toxicity (2333); No Information (3190)

Event Date 03/10/2011

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.The article was written by wataru ando, kengo yamamoto, takashi atsumi, satoshi tamaoki, kazuhiro oinuma, hideaki shiratsuchi, hirohiko tokunaga, yutaka inaba, naomi kobayashi, masaharu aihara and kenji ohzono.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 8 states, "dislocation and subluxation due to inadequate fixation and improper positioning.Muscle and fibrous tissue laxity can also contribute to these conditions." 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 1825034-2016-00011 / 00177).

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 right hip arthroplasty on (b)(6) 2011.Subsequently, elevated metal ions, increased cup inclination angle and cup anteversion were reported.Additional information reported the patient dislocated on (b)(6) 2011.No revision procedure has been reported to date.

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 1825034-2016-00011 / 00177 / 03192).Remains implanted.

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 right hip arthroplasty.Subsequently, elevated metal ions, increased cup inclination angle and cup anteversion were reported.Patient experienced a dislocation eight days post-implantation.No revision procedure has been reported to date.

• 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: 5340542
• MDR Text Key: 34931431
• Report Number: 0001825034-2016-00011
• 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
• Report Date: 07/22/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/04/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Physician
• Device Expiration Date: 06/30/2014
• Device Model Number: N/A
• Device Catalogue Number: 15-103682
• Device Lot Number: 262900
• Other Device ID Number: N/A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/22/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/24/2004
• 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: 64 YR
• Patient Weight: 57