MAUDE Adverse Event Report: ZIMMER BIOMET, INC. UNKNOWN 52MM M2A MAGNUM PF CUP; PROSTHESIS, HIP

Model Number N/A

Device Problem Material Erosion (1214)

Patient Problems Necrosis (1971); Metal Related Pathology (4530); Muscle/Tendon Damage (4532)

Event Date 06/18/2021

Event Type  Injury  

Manufacturer Narrative

(b)(4).Concomitant medical device: unknown: unk m2a magnum modular head 46mm-unknown unknown: unk modular taper locked femoral porous coated stem 9x137mm-unknown.Unknown: unk -3 taper adapter-unknown.Multiple mdr reports were filed for this event, please see associated reports: 0001825034-2022-01314.Reported event was confirmed via medical records provided and reviewed by a health care professional.No product was returned or pictures provided; visual and dimensional evaluations could not be performed.Part and lot identification are necessary for review of device history records, neither were 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.

Event Description

It was reported patient underwent a right hip revision approximately 14 years post implantation due to elevated metal ion levels and prominent metallosis.During revision, a pseudotumor was noted as well as metallosis and necrotic tissue.A repair of the abductor tendon was also necessary.All components were replaced without complication.Attempts have been made and additional information on the reported event is unavailable at this time.

• Brand Name: UNKNOWN 52MM M2A MAGNUM PF CUP
• 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: 14565524
• MDR Text Key: 293277176
• Report Number: 0001825034-2022-01313
• Device Sequence Number: 1
• Product Code: KWA
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: NI
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Consumer,Health Professional,Company Representative,Distributor
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 06/01/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/01/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• 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
• Date Manufacturer Received: 05/06/2022
• 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: NI
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Sex: Female