MAUDE Adverse Event Report: ZIMMER BIOMET, INC. UNK 56X50 MAGNUM CUP; PROSTHESIS, HIP

Model Number N/A

Device Problems Material Erosion (1214); Loosening of Implant Not Related to Bone-Ingrowth (4002)

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

Event Date 11/16/2020

Event Type  Injury  

Manufacturer Narrative

(b)(4).Concomitant medical products: unknown magnum head, unknown bimetric stem, unknown taper adapter.Multiple reports were submitted along with this report: 0001825034-2021-02875, 0001825034-2021-02876.Revision notes state that the patient was revised due to loosening and a large pseudotumor was debrided.The femur had significant loosening and the surgeon had to do an osteotomy to remove the stem.Reported event was confirmed by review of medical records received.Device history record (dhr) review was unable to be performed as the item and lot number of the device involved in the event is unknown.Root cause could not be determined as the necessary information to adequately investigate the reported event was not provided.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

It was reported that the patient was revised approximately 9 years later due to loosening of the acetabular and femoral components.During the revision, a large pseudotumor was debrided.All components were replaced with competitor product.No further event information available at the time of this report.

• Brand Name: UNK 56X50 MAGNUM CUP
• 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: 12638911
• MDR Text Key: 276603984
• Report Number: 0001825034-2021-02874
• Device Sequence Number: 1
• Product Code: KWY
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: N/A
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,consum
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 10/14/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/15/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: N/I
• Device Lot Number: N/I
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 10/04/2021
• 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): Hospitalization; Required Intervention