MAUDE Adverse Event Report: ZIMMER BIOMET, INC. M2A-MAGNUM 12/14 TPR 42-50 -3; PROSTHESIS, HIP

Model Number N/A

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Unequal Limb Length (4534)

Event Date 07/27/2023

Event Type  Injury  

Manufacturer Narrative

(b)(4).Multiple mdr reports were filed for this event, please see associated reports: 0001825034 - 2023 - 02805, 0001825034 - 2023 - 02806.The customer has indicated that the product will not be returned to zimmer biomet for investigation as its location is unknown.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.

Event Description

It was reported that the patient was revised approximately thirteen years post-implantation due to metallosis.During the revision, the competitor stem was found stable and without complications.When the acetabular shell was removed, metallosis tissue was debrided, and osteolytic defects were filled with grafting.The acetabular components were replaced with competitor products without complications.No further information has been provided.

Event Description

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

Manufacturer Narrative

(b)(4).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.Complaint confirmed based on evaluation of the provided medical records.Review of the device history record(s) identified no deviations or anomalies during manufacturing.Medical records were provided and reviewed and identified the following: trunnion clean and intact, stem stable.Metallosis tissue removed from behind the acetabular component.Severe osteolysis and defects within the acetabulum noted, hydroset applied.All zb components removed, replaced with competitor products.A definitive root cause cannot be determined.It is unknown if the off-label usage with a competitor stem caused or contributed to the event.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 12/14 TPR 42-50 -3
• 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: 18275151
• MDR Text Key: 329841347
• Report Number: 0001825034-2023-02807
• Device Sequence Number: 1
• Product Code: KWA
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K061423
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Consumer,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 03/15/2024

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?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 04/30/2018
• Device Model Number: N/A
• Device Catalogue Number: 239254
• Device Lot Number: 744660
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 11/13/2023
• Initial Date FDA Received: 12/06/2023
• Supplement Dates Manufacturer Received: 03/14/2024
• Supplement Dates FDA Received: 03/15/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/01/2008
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Sex: Female