MAUDE Adverse Event Report: ZIMMER BIOMET, INC. UNK M2A MAGNUM RECAP RESURFACING; PROSTHESIS, HIP

Model Number N/A

Device Problem Patient Device Interaction Problem (4001)

Patient Problems Failure of Implant (1924); Metal Related Pathology (4530)

Event Type  Injury  

Event Description

It was reported that a patient underwent an initial procedure on the right side.Approximately eleven years later, a ct scan was conducted for issues on their left side.A pseudotumor was noted on the right hip along with elevated metal ions.It is unknown if the patient received any treatment to the right hip.Attempts have been made and no further information has been provided.

Manufacturer Narrative

B)(4).A2: birth year ¿ 1945.B3: date of event ¿ (b)(6) 2019.D6a: implant date ¿ 2008.G2: foreign ¿ denmark.H6: proposed component code: mechanical (g04) ¿ head.No product was returned or pictures provided; visual and dimensional evaluations could not be performed.Complaint confirmed based on provided medical records.Part and lot identification are necessary for review of device history records, neither were provided.Medical records were provided and reviewed by a health care professional.Review of the available records identified the following: cobalt 30.5, chromium 29.0, ct scan: pseudotumor formation to bilateral hips.No report of intervention provided.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.

• Brand Name: UNK M2A MAGNUM RECAP RESURFACING
• Type of Device: PROSTHESIS, HIP
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; p.o. box 587; warsaw IN 46581
• Manufacturer (Section G): ZIMMER BIOMET, INC.; 56 e. bell drive; p.o. box 587; warsaw IN 46581
• Manufacturer Contact: jennifer rapsavage ; 56 e. bell dr.; warsaw, IN 46582 ; 5745260384
• MDR Report Key: 18104122
• MDR Text Key: 327757719
• Report Number: 0001825034-2023-02628
• Device Sequence Number: 1
• Product Code: KWA
• Combination Product (y/n): N
• Reporter Country Code: DA
• PMA/PMN Number: NI
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 11/09/2023

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: Lay User/Patient
• Device Model Number: N/A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 10/31/2023
• Initial Date FDA Received: 11/09/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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
• Patient Outcome(s): Other
• Patient Sex: Female
• Patient Weight: 62 KG