MAUDE Adverse Event Report: ZIMMER BIOMET, INC. UNK M2A MAGNUM TAPER; PROSTHESIS, HIP

Device Problems Corroded (1131); Mechanical Jam (2983)

Patient Problems Host-Tissue Reaction (1297); Pain (1994); Tissue Damage (2104); Reaction (2414)

Event Date 10/20/2016

Event Type  Injury  

Manufacturer Narrative

(b)(4).Concomitant medical products: unknown-m2a mag cup-unknown, unknown-m2a mag head-unknown, unknown-unknown stem-unknown.Multiple mdr reports were filed for this event, please see associated reports: 0001825034 - 2019 - 05618, 0001825034 - 2019 - 05619, 0001825034 - 2019 - 05621.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 that a patient underwent a left hip arthroplasty and was revised 8 years post-op.Metallosis was present within the joint with staining of the capsular tissue in addition to a pseudotumor emanating from the joint and extending posteriorly and medially along the obturator externus tendon.Taper was cold welded to the femoral component.Corrosive debris on the neck taper.Attempts have been made and additional information on the reported event is unavailable at this time.

Event Description

No additional event information to report at this time.

Manufacturer Narrative

This follow-up report is being submitted to relay additional information.Reported event was confirmed by review of medical records noting adverse local tissue reaction, pseudotumor, pain, elevated metal ion levels, tissue damage, metallosis, and in-vivo implant corrosion.Inflammatory markers and hip aspiration were found to be negative for infection.Cobalt chromium levels were highly elevated.An mri demonstrated inflammatory pseudotumor posteriorly.Damage to the abductors and metallosis in the joint space was noted along with cold-welding of the taper to the stem.When the taper was removed, there was corrosive debris on the neck.Device history record (dhr) review was unable to be performed as the lot number of the device involved in the event is unknown.Root cause was unable to 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: UNK M2A MAGNUM TAPER
• Type of Device: PROSTHESIS, HIP
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• MDR Report Key: 9490253
• MDR Text Key: 172244782
• Report Number: 0001825034-2019-05620
• 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,health professional
• Type of Report: Initial,Followup
• Report Date: 01/02/2020

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
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 11/25/2019
• Initial Date FDA Received: 12/18/2019
• Supplement Dates Manufacturer Received: 12/31/2019
• Supplement Dates FDA Received: 01/03/2020
• 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