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

Model Number N/A

Device Problem Material Erosion (1214)

Patient Problems Host-Tissue Reaction (1297); Pain (1994); Local Reaction (2035); Osteolysis (2377)

Event Date 02/20/2020

Event Type  Injury  

Manufacturer Narrative

(b)(4).Concomitant medical products: 157448- m2a-magnum mod hd sz 48mm-609270, 139252-m2a-magnum 42-50mm tpr insrt-6-946190, 192411-echo por fmrl red nc 11x135mm-271740.Multiple mdr reports were filed for this event, please see associated reports: 0001825034 2020-02888.Customer has indicated that the product will not be returned to zimmer biomet for investigation, product location unknown.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.

Event Description

It was reported the patient underwent a left hip revision approximately 10 years post implantation due to pain, elevated metal ion levels, pseudotumor, osteolysis, and altr.Operative report findings include enlargement of the trochanteric bursa related to a fluid formation and pseudocapsule formation that was emerging from the hip joint, extending over lateral aspect of the femur and posteriorly.There was moderate amount of serosanguinous fluid from inside the pseudocapsule.Fibrosis was found, tissue reaction that maybe related to adverse tissue reaction to metalon-metal hip could be seen.Acetabulum removed with minimal bone loss, small area of osteolysis posteriorly.The initial stem remains implanted.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.Reported event was confirmed via medical records and radiographs reviewed by a health care professional.Review of the device history records identified no deviations or anomalies during manufacturing.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.

Event Description

No additional information on the reported event.

Manufacturer Narrative

This follow-up report is being submitted to relay additional information.One m2a-magnum pf cup 54odx48id item# us157854 lot# 836120 was returned and evaluated.Upon visual inspection the cup had debris on the od and scuffing on the inner radius.The additional information does not change the outcome of the previous investigation.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; 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: 10313940
• MDR Text Key: 203637437
• Report Number: 0001825034-2020-02887
• 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,Distributor
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 03/14/2022

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: 12/31/2019
• Device Model Number: N/A
• Device Catalogue Number: US157854
• Device Lot Number: 836120
• 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: 06/30/2020
• Initial Date FDA Received: 07/23/2020
• Supplement Dates Manufacturer Received: 09/28/2020; 03/08/2022
• Supplement Dates FDA Received: 09/29/2020; 03/14/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/01/2009
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: NI
• Patient Sequence Number: 1
• Treatment: SEE H10
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Sex: Female