MAUDE Adverse Event Report: BIOMET ORTHOPEDICS M2A 38MM MODULAR HEAD +3MM NK; PROSTHESIS, HIP

Model Number N/A

Device Problems Fracture (1260); Unstable (1667); Metal Shedding Debris (1804)

Patient Problems Pain (1994); Swelling (2091)

Event Date 05/05/2015

Event Type  Injury  

Event Description

It was reported that patient underwent initial left total hip arthroplasty on (b)(6) 2006.Subsequently, patient was revised on (b)(6) 2015 allegedly due to pain and instability.It was further reported that a rim screw fractured during the revision procedure, but it is unknown if the fracture occurred prior to or during removal.The modular head and acetabular cup were removed and replaced with a biomet head and competitor cup.

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.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." under warnings, it states, "improper selection, placement, positioning, alignment and fixation of the implant components may result in unusual stress conditions which may lead to subsequent reduction in the service life of the prosthetic components.".

Manufacturer Narrative

This follow-up report is being submitted to relay additional information.Multiple mdr reports were filed for this event, please see associated reports: 0001825034-2015-02115, 0001825034-2015-02114, 0001825034-2017-08157.Concomitant products: m2a 38mm mod hd +3mm nk catalog# 11-173663 lot 964290, m2a 1 pc shell 38mmx58mm catalog# 15-105058 lot# 570270, unknown hip screw.Reported event was unable to be confirmed due to limited information received from the customer.Device history record was reviewed and no discrepancies were found.Root cause was unable to be determined as the necessary information to adequately investigate the reported event was not provided.There are warnings in the package insert that this type of event can occur and risks are addressed in risk documentation.A summary of the investigation has been sent to the complainant.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.

Manufacturer Narrative

This follow-up report is being submitted to relay additional information.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.

Event Description

Additional medical records received stated, lab work prior to the revision showed elevated ion levels.During the revision it a brownish fluid was encountered.

• Brand Name: M2A 38MM MODULAR HEAD +3MM NK
• Type of Device: PROSTHESIS, HIP
• Manufacturer (Section D): BIOMET ORTHOPEDICS; 56 e. bell drive; warsaw IN 46582
• Manufacturer (Section G): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• Manufacturer Contact: christina arnt ; 56 e. bell dr.; warsaw, IN 46582 ; 5745273773
• MDR Report Key: 4785783
• MDR Text Key: 5799249
• Report Number: 0001825034-2015-02114
• Device Sequence Number: 1
• Product Code: LZO
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: PK062997
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Company Representative,company representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 11/28/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/20/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Expiration Date: 04/30/2016
• Device Model Number: N/A
• Device Catalogue Number: 11-173663
• Device Lot Number: 964290
• Other Device ID Number: N/A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/30/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/22/2005
• 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): Hospitalization; Required Intervention
• Patient Age: 59 YR