MAUDE Adverse Event Report: BIOMET ORTHOPEDICS UNKNOWN MAGNUM M2 HEAD; PROSTHESIS, HIP

Model Number N/A

Device Problem Metal Shedding Debris (1804)

Patient Problem Reaction (2414)

Event Date 11/02/2015

Event Type  Injury  

Manufacturer Narrative

(b)(4).Concomitant product(s): unknown stem.Report source: country: (b)(6).Reported event was unable to be confirmed as part number / lot number of device involved in the incident is unknown.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.Maarten c.Koper, nina m.C.Mathijssen, stephan b.W.Vehmeijer, et al.A 5-year survival analysis of 160 biomet magnum m2 metal-on-metal total hip prostheses issn 1120-7000.Multiple mdr reports were filed for this event, please see associated reports: 0001825034 - 2017 - 05527.

Event Description

It was reported in a journal article that 4 patients experienced a possible pseudotumour.No further information is available.

• Brand Name: UNKNOWN MAGNUM M2 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: 6767599
• MDR Text Key: 81899954
• Report Number: 0001825034-2017-05536
• Device Sequence Number: 1
• Product Code: LZO
• Combination Product (y/n): N
• Reporter Country Code: NL
• 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: 08/01/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/04/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Physician
• Device Model Number: N/A
• Other Device ID Number: N/A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/10/2017
• 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): Other