MAUDE Adverse Event Report: ZIMMER BIOMET, INC. M2A-38 CUP 58MM; PROSTHESIS, HIP

Model Number N/A

Device Problems Material Erosion (1214); Naturally Worn (2988)

Patient Problems Pain (1994); Tissue Damage (2104); Reaction (2414)

Event Date 05/01/2019

Event Type  Injury  

Manufacturer Narrative

(b)(4).Concomitant medical products: 11-173663 ¿ m2a head ¿ 114110, x11-180311 ¿ bimetric stem ¿ 058950.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 - 03933, 0001825034 - 2020 - 03934.

Event Description

It was reported that patient underwent a right hip revision approximately 16 years post implantation due to metallosis, elevated metal ion levels, pain, tissue damage, in-vivo corrosion and implant wear.The head and cup were 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 right hip pain, possible chronic aseptic lymphocyte-dominated vasculitis-associated lesion.Mild metallosis along with mild trunnion corrosion and chronic abductor tear is noted.Patient has elevated cobalt-chromium levels and the joint was noted to have mild tissue staining.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-38 CUP 58MM
• Type of Device: PROSTHESIS, HIP
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• MDR Report Key: 10755085
• MDR Text Key: 213658004
• Report Number: 0001825034-2020-03932
• Device Sequence Number: 1
• Product Code: KWA
• Combination Product (y/n): N
• PMA/PMN Number: K011110
• 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: 12/23/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/29/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 11/30/2012
• Device Model Number: N/A
• Device Catalogue Number: RD118858
• Device Lot Number: 224320
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 12/22/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention