MAUDE Adverse Event Report: ZIMMER BIOMET, INC. M2A-MAGNUM PF CUP 54ODX48ID; PROSTHETIC, HIP

Model Number N/A

Device Problem Material Erosion (1214)

Patient Problems Host-Tissue Reaction (1297); Necrosis (1971); Pain (1994); Local Reaction (2035); Tissue Damage (2104); Reaction (2414); Metal Related Pathology (4530)

Event Date 11/13/2017

Event Type  Injury  

Manufacturer Narrative

(b)(4).Concomitant medical products: item# 139252 item name m2a-magnum 42-50mm tpr insrt-6 lot # 484590.Item# 192508 item name echo por fmrl red lat nc 8x120 lot # 020100.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 is completed, a supplemental mdr will be submitted.Multiple mdr reports were filed for this event, please see associated reports: 0001825034 - 2020 - 04192.

Event Description

It was reported initial right total hip arthroplasty performed.Subsequently, the patient was revised 5 years later due to pain and metallosis.During the revision, a ceramic head and active articulation system bearing replaced the existing metal on metal components.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.The following sections were updated/corrected updated: b6; d4; g3; h2; h3; h6 no product was returned or pictures provided; visual and dimensional evaluations could not be performed.A review of the device history records identified no deviations or anomalies during manufacturing.Medical records/radiographs were provided and reviewed by a health care professional.Review of the available records identified the following: suffered heavy metal poisoning, tissue death, bone loss, and pain¿lost her mobility¿limitation of daily activities during the procedure, dr.Wood found metallosis in the subcutaneous tissue at the hip joint and gluteal fibers.Excised fibrinous and synovial tissue from the acetabular was found to be ¿necrotic¿ (dead), inflammatory reaction, confirming his diagnosis of metallosis 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.

Event Description

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

• Brand Name: M2A-MAGNUM PF CUP 54ODX48ID
• Type of Device: PROSTHETIC, HIP
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• MDR Report Key: 10904614
• MDR Text Key: 218266416
• Report Number: 0001825034-2020-04193
• 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
• Type of Report: Initial,Followup
• Report Date: 03/11/2021

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: 05/30/2022
• Device Model Number: N/A
• Device Catalogue Number: US157854
• Device Lot Number: 496780
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 11/13/2020
• Initial Date FDA Received: 11/25/2020
• Supplement Dates Manufacturer Received: 03/10/2021
• Supplement Dates FDA Received: 03/11/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Treatment: SEE H10 NARRATIVE
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 50 YR