MAUDE Adverse Event Report: ZIMMER BIOMET, INC. M2A-MAGNUM HEAD; PROSTHESIS, HIP

Model Number N/A

Device Problem Material Erosion (1214)

Patient Problems Pain (1994); Reaction (2414)

Event Date 02/20/2018

Event Type  Injury  

Manufacturer Narrative

(b)(4).Concomitant medical products: us257854 ¿ magnum trispike cup ¿ 757040; 103205 ¿ taperloc femoral stem ¿ 012690; 139254 ¿ m2a magnum taper ¿ 037760.Customer has indicated that the product will not be returned to zimmer biomet for investigation as the product location is unknown.The investigation is in process.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 -2018 -10992.

Event Description

It was reported patient underwent a hip revision approximately 9 years post implantation due to pain and elevated metal ion levels.Attempts have been made and additional information on the reported event is unavailable at this time.

Manufacturer Narrative

(b)(4).This follow-up report is being submitted to relay additional information.Reported event was confirmed by review of medical records.Medical records were provided and reviewed by a health care professional.Review of the available records identified the following: primary op notes were reviewed and no complications were noted.Revision op notes were reviewed and identified patient was revised due to adverse reaction to metal debris.X-rays were provided and the review identified symmetric and central position of the femoral head within the acetabular cup with no evidence for polyethylene wear.Femoral stem is intact with no evidence for radiolucency to suggest loosening.No bony fracture.No product was returned; visual and dimensional evaluations could not be performed.No product was returned; visual and dimensional evaluations could not be performed.A definitive root cause could not 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. .

• Brand Name: M2A-MAGNUM HEAD
• Type of Device: PROSTHESIS, HIP
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• MDR Report Key: 8120482
• MDR Text Key: 128913545
• Report Number: 0001825034-2018-10991
• Device Sequence Number: 1
• Product Code: KWY
• Combination Product (y/n): N
• PMA/PMN Number: K042037
• 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: 06/03/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/30/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 08/31/2019
• Device Model Number: N/A
• Device Catalogue Number: 157448
• Device Lot Number: 721160
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 05/30/2019
• 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
• Patient Age: 46 YR
• Patient Weight: 68