MAUDE Adverse Event Report: ZIMMER BIOMET, INC. M2A-MAGNUM PF CUP 56ODX50ID; PROSTHESIS, HIP

Model Number N/A

Device Problem Unstable (1667)

Patient Problems Host-Tissue Reaction (1297); Pain (1994); Local Reaction (2035); Reaction (2414)

Event Date 04/09/2019

Event Type  Injury  

Manufacturer Narrative

(b)(4).Concomitant medical products: 157450 lot 471960 m2a head 50mm head, 139256 lot 873560 m2a taper adapter, 103206 lot 738440 taperloc femoral stem 12.5x145mm.Customer has indicated that the product will not be returned to zimmer biomet for investigation.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: 0001825034-2020-01831.

Event Description

Initial left total hip arthroplasty performed and, the patient was revised eight years later due to pain and instability.During the revision, extensive metallosis and a large pseudocyst was noted.All components were revised with unknown product without complication.Attempts have been made and no further information has been provided.

Event Description

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

Manufacturer Narrative

(b)(4).Reported event was confirmed by review of medical records.Device history record (dhr) was reviewed and no discrepancies were found.Root cause was unable to be determined.Review of medical records identified left hip pain with possible instability, extensive metallosis with major pseudocyst.Ebl 400ml with prbc transfusion.Major pseudocyst with metallosis present and black tissue.Femur extremely well-fixed, eto performed to remove the component and secured with cables.All components replaced with unknown product.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.

• Brand Name: M2A-MAGNUM PF CUP 56ODX50ID
• Type of Device: PROSTHESIS, HIP
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• MDR Report Key: 10010030
• MDR Text Key: 198597872
• Report Number: 0001825034-2020-01832
• Device Sequence Number: 1
• Product Code: LPH
• Combination Product (y/n): N
• PMA/PMN Number: K101336
• 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: 07/22/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/29/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 09/30/2020
• Device Model Number: N/A
• Device Catalogue Number: US157856
• Device Lot Number: 365010
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 07/20/2020
• 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