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

Model Number N/A

Device Problem Patient Device Interaction Problem (4001)

Patient Problems Pain (1994); Osteolysis (2377); Reaction (2414); Limited Mobility Of The Implanted Joint (2671)

Event Date 05/11/2020

Event Type  Injury  

Manufacturer Narrative

(b)(4).Concomitant medical devices: cat# 139259 m2a magnum 42-50m tpr insrt +6 lot# 348150; cat# 157440 m2a-magnum mod hd sz 40mm lot# 946000; cat# 192110 echo por fmrl lat nc 10x130mm lot#146930.The device will not be returned for analysis, as the device location is unknown; however, an investigation of the reported event is in progress.Once the investigation is completed, a supplemental medwatch 3500a will be submitted.Multiple mdr reports were filed for this event, please see associated reports: 0001825034 - 2020 - 03596, 0001825034 - 2020 - 03597, 0001825034 - 2020 - 03595.

Event Description

It was reported the patient underwent a left hip revision approximately 10 years post implantation due to metallosis, pain that interfered with activities of daily living, and osteolysis.During the procedure, the surgeon noted the following: elevated cobalt and chromium levels, difficulty removing the head, and femoral stem and acetabular cup were well fixed.The stem and cup were retained.Attempts have been made and no further information has been provided.

Event Description

No further event information available 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 related to the reported event.-medical records were provided and reviewed by a health care professional.Review of the available records identified the following: pain which interfered with activities of daily living.Elevated cobalt and chromium.Mri showed pseudotumor.X-ray shows lysis around femoral and acetabular components.Significant amount of friable grayish/brown tissue consistent with metallosis was encountered and sent for analysis.Removal of the femoral head was difficult and took repeated attempts.Femoral component was well fixed despite concern on x-ray for lysis.Attempt made to extract however stem remained well fixed and was left in place.Attempt also made to remove acetabular component, however remained well fixed.-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; warsaw IN 46582
• MDR Report Key: 10585663
• MDR Text Key: 208502877
• Report Number: 0001825034-2020-03606
• 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,health professional
• Type of Report: Initial,Followup
• Report Date: 11/20/2020

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: 01/31/2020
• Device Model Number: N/A
• Device Catalogue Number: US157854
• Device Lot Number: 091380
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 09/02/2020
• Initial Date FDA Received: 09/25/2020
• Supplement Dates Manufacturer Received: 11/19/2020
• Supplement Dates FDA Received: 11/23/2020
• 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