MAUDE Adverse Event Report: ZIMMER BIOMET, INC. M2A 38MM HEAD; PROSTHESIS, HIP

Model Number N/A

Device Problem Material Erosion (1214)

Patient Problems Host-Tissue Reaction (1297); Pain (1994); Local Reaction (2035); Tissue Damage (2104)

Event Date 10/01/2019

Event Type  Injury  

Manufacturer Narrative

(b)(4).Concomitant medical devices: 15-106048¿ m2a cup ¿ 653050; 103203 ¿ taperloc stem - 034530.Customer has indicated that the product will not be returned to zimmer biomet for the investigation as the product location is unknown.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.Multiple mdr reports were filed for this event, please see associated reports: 0001825034 - 2020 - 02719, 0001825034 - 2020 - 02720.

Event Description

It was reported that patient developed pain and elevated metal ion levels post right total hip arthroplasty.Approximately 11 years post implantation the patient underwent a revision surgery where a pseudotumor was excised and tissue damage and corrosion on the trunnion of the stem was noted.The head component was removed and replaced.Attempts have been made and additional information on the reported event is unavailable at this time.

Manufacturer Narrative

This follow-up report is being submitted to relay additional information.Reported event was confirmed by review of medical records noting elevated metal ion levels, pain and suspected local adverse tissue effects possible alval.Pseudotumor cyst was found and excised.Mild to moderate corrosion to the trunnion and black staining also found.Dhr was reviewed and no discrepancies were found.The root cause is 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.

Event Description

No further event information available at the time of this report.

• Brand Name: M2A 38MM HEAD
• Type of Device: PROSTHESIS, HIP
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• MDR Report Key: 10264844
• MDR Text Key: 198598544
• Report Number: 0001825034-2020-02721
• Device Sequence Number: 1
• Product Code: LZO
• Combination Product (y/n): N
• PMA/PMN Number: K062997
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,health professional
• Type of Report: Initial,Followup
• Report Date: 10/13/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/31/2018
• Device Model Number: N/A
• Device Catalogue Number: 11-173663
• Device Lot Number: 089620
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 06/19/2020
• Initial Date FDA Received: 07/13/2020
• Supplement Dates Manufacturer Received: 10/12/2020
• Supplement Dates FDA Received: 10/13/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Treatment: SEE H10
• Patient Outcome(s): Hospitalization; Required Intervention