MAUDE Adverse Event Report: BIOMET ORTHOPEDICS UNKNOWN M2A MAGNUM HEAD; PROSTHESIS, HIP

Model Number N/A

Device Problem Insufficient Information (3190)

Patient Problem Death (1802)

Event Date 03/01/2017

Event Type  Death  

Manufacturer Narrative

(b)(4).Date journal article was published.Medical products: unk m2a magnum cup, calalog#: ni, lot# ni; unk m2a magnum taper, calalog#: ni, lot# ni; unk stem, calalog#: ni, lot# ni; therapy date: ni.Mantymaki, h., junnila, m., lankinen, p., seppanen, m., vahlberg, t., & makela, k.(2017).Systematic screening of adverse reactions to metal debris after recap-m2a-magnum metal-on-metal total hip arthroplasty.Systematic screening of adverse reactions to metal debris after recap-m2a-magnum metal-on-metal total hip arthroplasty.Doi:https://doi.Org/10.1177/1457496916683093.Reported event was unable to be confirmed.Device history record review was unable to be performed as the lot number of the device involved in the event is unknown.Root cause was unable to be determined as the necessary information to adequately investigate the reported event was not provided.If any further information is found which would change or alter any conclusions or information, a supplemental will be filed accordingly.Zimmer biomet will continue to monitor for trends.Multiple mdr reports were filed for this event, please see associated reports: 0001825034-2017-06031, 0001825034-2017-06034, 0001825034-2017-06035.

Event Description

It was reported in a journal article that 96 patients expired due to unknown reasons.This information was collected during a mean follow up period of 5.2 years.Attempts have been made and additional information on the reported event is unavailable.

• Brand Name: UNKNOWN M2A MAGNUM HEAD
• 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: christina arnt ; 56 e. bell dr.; warsaw, IN 46582 ; 5745273773
• MDR Report Key: 6775136
• MDR Text Key: 82108848
• Report Number: 0001825034-2017-06033
• Device Sequence Number: 1
• Product Code: KWA
• Combination Product (y/n): N
• Reporter Country Code: FI
• PMA/PMN Number: PNI
• 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: 08/08/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/08/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Physician
• Device Model Number: N/A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/07/2017
• 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): Death