MAUDE Adverse Event Report: ZIMMER BIOMET, INC. M2A-MAGNUM MOD HD SZ 46MM; PROSTHESIS, HIP

Model Number N/A

Device Problem Insufficient Information (3190)

Patient Problems Erosion (1750); Pain (1994); Local Reaction (2035); Osteolysis (2377); Reaction (2414); Limited Mobility Of The Implanted Joint (2671)

Event Date 03/10/2020

Event Type  Injury  

Manufacturer Narrative

(b)(4).Concomitant medical devices: 192011, echo por fmrl nc, 11x135mm, 555530; 139254, m2a-magnum 42-50mm, tpr insrt-3, 452410; us157852, m2a-magnum pf cup, 52odx46id, 691000.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 - 02468.

Event Description

It was reported that the patient had an initial left hip replacement.The patient was revised ten years later due to pain, metal pathology, osteolysis and ambulation difficulties.The head, liner and cup were revised.Patient states that she is still experiencing pain and limited mobility.No additional information is available.

Manufacturer Narrative

(b)(4).This follow-up report is being submitted to relay additional information.Updated: b4, b5, g4, h2, h3, h6.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.Medical records were provided and reviewed by a health care professional.The patient underwent a revision procedure due to to pain, metal pathology, osteolysis and ambulation difficulties.Mri show findings consistent with osteolysis, large separated debris containing fluid collection around the left hip joint consistent with adverse reaction to particulate debris.Metallosis encountered with metal reactive tissue removed from the proximal portion of the femur.If any further information is found which would change or alter any conclusions or information, a supplemental report 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-MAGNUM MOD HD SZ 46MM
• Type of Device: PROSTHESIS, HIP
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• MDR Report Key: 10189513
• MDR Text Key: 196745410
• Report Number: 0001825034-2020-02469
• Device Sequence Number: 1
• Product Code: KWA
• Combination Product (y/n): N
• PMA/PMN Number: K042037
• 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: 08/12/2020

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: 07/31/2020
• Device Model Number: N/A
• Device Catalogue Number: 157446
• Device Lot Number: 983650
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 06/16/2020
• Initial Date FDA Received: 06/24/2020
• Supplement Dates Manufacturer Received: 08/07/2020
• Supplement Dates FDA Received: 08/12/2020
• 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