MAUDE Adverse Event Report: ZIMMER BIOMET, INC. M2A 38MM MOD HD STD NK; PROSTHESIS, HIP

Catalog Number 11-173662

Device Problem Material Erosion (1214)

Patient Problems Erosion (1750); Unspecified Infection (1930); Pain (1994); Tissue Damage (2104); Discomfort (2330); Limited Mobility Of The Implanted Joint (2671)

Event Date 05/21/2019

Event Type  Injury  

Manufacturer Narrative

(b)(4).Concomitant medical products: us157844-magnum cup-272790, 14-103202-taperloc microp fmrl-472840.Multiple mdr reports were filed for this event, please see associated reports: 0001825034 - 2020 - 00410.Customer has indicated that the product will not be returned to zimmer biomet for investigation, product location unknown.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.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.Product not returned.

Event Description

It was reported that patient underwent a revision procedure approximately 11 years post implantation due to pain, discomfort, lack of mobility, elevated ion levels, infection, tissue damage, bone erosion, and metal wear.Attempts have been made and additional information on the reported event is unavailable at this time.

Event Description

It was reported patient underwent a left hip revision approximately 11 years post implantation due to pain.During the revision metallosis fluid and tissue noted.The head was exchanged with sleeve and bearing added.Stem and cup remained intact.No complications were noted.Attempts have been made and additional information on the reported event is unavailable at this time.

Manufacturer Narrative

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

No additional information on reported event.

Manufacturer Narrative

This follow-up report is being submitted to relay additional information.Reported event was unable to be confirmed.Device history record (dhr) was reviewed and no discrepancies were found.Root cause was unable to be determined.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.Reported event was confirmed via medical records and radiographs that were reviewed by a health care professional.A review of the available records identified findings of the reported issues metal artifcats noted in radiology report, avulsion fracture of trochanter with no medical intervention, increase in pain noted, metallosis fluid, femoral and acetabular components well fixed.The lab notes identified elevated metal ions.The additional information does not change the outcome of the previous investigation.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

No additional information on the reported event.

• Brand Name: M2A 38MM MOD HD STD NK
• Type of Device: PROSTHESIS, HIP
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 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: 9636463
• MDR Text Key: 176579449
• Report Number: 0001825034-2020-00411
• Device Sequence Number: 1
• Product Code: LZO
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K062997
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Consumer,Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 01/19/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/28/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 01/31/2018
• Device Catalogue Number: 11-173662
• Device Lot Number: 750640
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 01/18/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/01/2008
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Removal/Correction Number: NI
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Sex: Female