MAUDE Adverse Event Report: ZIMMER BIOMET, INC. M2A-MAGNUM PF CUP 52ODX46ID; PROSTHESIS, HIP

Model Number N/A

Device Problem Material Erosion (1214)

Patient Problems Host-Tissue Reaction (1297); Local Reaction (2035); Scar Tissue (2060); Osteolysis (2377)

Event Date 11/26/2019

Event Type  Injury  

Manufacturer Narrative

(b)(4).Concomitant medical products: 157446-m2a-magnum mod hd sz 46mm-167860.103201-taperloc por fmrl 6.0x132-159150.139259-m2a magnum 42-50m tpr insrt +6-631060.Multiple mdr reports were filed for this event, please see associated reports: 0001825034-2020-03006, 0001825034-2020-01914, 0001825034-2020-01886.Customer has indicated that the product will not be returned to zimmer biomet for investigation, product remains implanted.Reported event was confirmed via medical records and radiographs reviewed by a health care professional.Review of the available records identified the following: (summarized by hcp) positive mri findings and mild elevation consistent with metal failure, released adhesions/scar tissue.Released posterior hip pseudocapsule.Tannish loose tissue debris was identified consistent w/metal reaction, frozen sections sent for review were not suspicious.Review of the device history records identified no deviations or anomalies during manufacturing.A definitive root cause cannot 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

It was reported the patient underwent a left hip revision approximately 11 years post implantation due to positive mri findings and elevated metal ions.During the procedure pseudocapsule was released.Tannish loose tissue debris was identified consistent w/metal reaction.Osteolysis noted around posterior femur.Attempts have been made and additional information on the reported event is unavailable at this time.

• Brand Name: M2A-MAGNUM PF CUP 52ODX46ID
• 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: 10368556
• MDR Text Key: 202041007
• Report Number: 0001825034-2020-03005
• Device Sequence Number: 1
• Product Code: LPH
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K101336
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,consum
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 08/05/2020

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: 09/30/2018
• Device Model Number: N/A
• Device Catalogue Number: US157852
• Device Lot Number: 072340
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 07/20/2020
• Initial Date FDA Received: 08/05/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/01/2008
• 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