MAUDE Adverse Event Report: ZIMMER BIOMET, INC. BIOMET M2A CUP; PROSTHESIS, HIP

Model Number N/A

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

Patient Problems Host-Tissue Reaction (1297); Nerve Damage (1979); Pain (1994); Local Reaction (2035); Osteolysis (2377)

Event Date 08/27/2018

Event Type  Injury  

Manufacturer Narrative

(b)(4).Implant date: unknown date in 2007.Concomitant medical devices: biomet m2a cup cat# ni lot#854350; unknown biomet magnum head; unknown stem; biomet cerclage cable up cat#ni lot#548980.The device will not be returned for analysis, due to location of device is unknown; however, an investigation of the reported event is in progress.Once the investigation has been completed, a follow-up mdr will be submitted.Multiple mdr reports were filed for this event, please see associated reports: 0001825034 - 2020 - 03112.

Event Description

It was reported a patient had an initial left tha.Subsequently, the patient was revised approximately 11 years later due to altr, pseudotumor, peripheral nerve damage, pain, elevated ion levels, and osteolysis.Attempts have been made and additional information on the reported event is unavailable at this time.

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.Visual examination of the provided pictures identified a shell, liner, and cable were removed, the cup shows signs of bone on growth.Medical records/radiographs were provided and reviewed by a health care professional.Review of the available records identified the following: failed left th replacement related to adverse tissue reaction to mom articulation.Excision of pseudotumor.Neurolysis of the sciatic nerve, left.New onset acute pain left hip.Highly elevated ion levels ¿ chromium 68.5 and cobalt 57.6 discolored tissue with thickened synovial pseudocapsule.Extensive pseudotumor extension posterior to the sciatic nerve into the ischium.A large amount of turbid fluid emerging from the joint.Significant bone loss from the superior posterior portion of the acetabulum.Tissue was gray-black in color with fibrillation.There was osteolysis on the superior posterior and inferomedial aspect of the acetabulum.No intra-operative complications.Device history record review was unable to be performed as the lot number of the device involved in the event is unknown.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: BIOMET M2A CUP
• Type of Device: PROSTHESIS, HIP
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• MDR Report Key: 10402441
• MDR Text Key: 202884334
• Report Number: 0001825034-2020-03111
• Device Sequence Number: 1
• Product Code: KWA
• Combination Product (y/n): N
• PMA/PMN Number: NI
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer
• Type of Report: Initial,Followup
• Report Date: 10/01/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/13/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: N/A
• Device Lot Number: 854350
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 09/25/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention