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

Model Number N/A

Device Problems Adverse Event Without Identified Device or Use Problem (2993); Noise, Audible (3273); Patient Device Interaction Problem (4001)

Patient Problems Bone Fracture(s) (1870); Pain (1994); Osteolysis (2377); Metal Related Pathology (4530); Muscle/Tendon Damage (4532)

Event Date 05/24/2022

Event Type  Injury  

Manufacturer Narrative

(b)(4).Concomitant medical products: cat# 103207, lot# 925550 ,taperloc por fmrl 13.5x147, cat# 139256, lot# 201480, m2a-magnum 42-50 tpr insrt std.Multiple mdr reports were filed for this event, please see associated reports: 0001825034 - 2023 - 00523.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 underwent right metal-on-metal hip arthroplasty that was subsequently revised approximately eleven (11) years later due to metal-on-metal right hip.Both the acetabular and femoral components were revised.During the revision, pseudotumor and some metal debris was observed.Moderate osteolysis at the acetabulum was noted.It was also noted that a portion of the porous coating of the cup stayed intact inferiorly.While attempting to remove this portion, the inferior portion of the acetabulum sustained a fracture.The procedure was completed without further complications.Attempts have been made and no further information has been provided.

Event Description

No further information 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.Review of the device history record(s) identified no deviations or anomalies during manufacturing.Medical records were provided and reviewed by a health care professional.Review of the available records identified the following: moderately advanced osteolysis at the acetabulum.Medial defect as well as anterior and inferior wall deficiency was noted.Patient experiencing increased pain.Mri reveals pseudotumor and some adverse reaction to metal debris.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 information at the time of this report.

Manufacturer Narrative

This follow-up report is being submitted to relay additional information.Visual examination of the returned product identified the shell has debris on the od along with scuffing to the inner radius.Review of the device history record(s) identified no deviations or anomalies during manufacturing.Medical records were provided and reviewed by a health care professional.Review of the available records identified the following: moderately advanced osteolysis at the acetabulum.Medial defect as well as anterior and inferior wall deficiency was noted.Patient experiencing increased pain.Mri reveals pseudotumor and some adverse reaction to metal debris.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: M2A-MAGNUM PF CUP 54ODX48ID
• 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: 16519370
• MDR Text Key: 311039547
• Report Number: 0001825034-2023-00522
• Device Sequence Number: 1
• Product Code: LPH
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K101336
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Consumer,Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 10/27/2023

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: Health Professional
• Device Expiration Date: 10/01/2020
• Device Model Number: N/A
• Device Catalogue Number: US157854
• Device Lot Number: 557630
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 02/17/2023
• Initial Date FDA Received: 03/09/2023
• Supplement Dates Manufacturer Received: 05/11/2023; 10/25/2023
• Supplement Dates FDA Received: 05/11/2023; 11/03/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/01/2010
• 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): Required Intervention; Hospitalization
• Patient Sex: Female