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

Model Number N/A

Device Problem Material Erosion (1214)

Patient Problems Pain (1994); Burning Sensation (2146); Metal Related Pathology (4530); Solid Tumour (4552); Swelling/ Edema (4577)

Event Type  Injury  

Manufacturer Narrative

(b)(4).Implant date: unknown month and day in 2006.The device will not be returned for analysis, as the device remains implanted; however, an investigation of the reported event is in progress.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: 0001825034-2022-00086, 0001825034-2022-00088.

Event Description

It was reported that approximately 15 years post implantation, the patient is experiencing severe burning, pain, and massive swelling due to the metal on metal hip that is causing swelling of her joints.Orthopedic surgeon has aspirated to remove the metal debris/blood collection.The surgeon recently told her after having recent surgery to partially remove a massive tumor that is being caused by the hip that her anatomy is being eaten away from the metal.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.

Event Description

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

Manufacturer Narrative

This follow-up report is being submitted to relay additional information.No product was returned or pictures provided; visual and dimensional evaluations could not be performed.Radiograph reports were provided and reviewed by a health care professional.Review of the available records identified the following: x-ray, mri, ct, fluoroscopy report findings of status post right hip arthroplasty.Intact acetabular and femoral components with effusion, pseudocapsule, synovitis and metal debris.Ct and doppler of right thigh findings are 2 fluid collections in right pelvis and right thigh.The larger fluid structure in the right pelvis extends inferiorly into the soft tissues of the right thigh, probable myomatous of the uterus.The right hip structure is suggestive of a cyst.Doppler findings, no dvt, patent venous structures.Device history record was reviewed and no discrepancies relevant to the reported event were found.Root cause was 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.

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
• 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: 13237617
• MDR Text Key: 283748345
• Report Number: 0001825034-2022-00087
• Device Sequence Number: 1
• Product Code: KWA
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K042037
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Consumer
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 03/29/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/12/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 08/31/2016
• Device Model Number: N/A
• Device Catalogue Number: 157446
• Device Lot Number: 160170
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 03/28/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/01/2006
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Treatment: CAT#: US157852 M2A CUP LOT#: 180314.; UNKNOWN TAPER ADAPTER.
• Patient Outcome(s): Other
• Patient Sex: Female