MAUDE Adverse Event Report: ZIMMER BIOMET, INC. M2A-MAGNUM 42-50MM TPR INSRT-6; PROSTHESIS HIP

Model Number N/A

Device Problem Insufficient Information (3190)

Patient Problems Sepsis (2067); No Code Available (3191)

Event Date 10/23/2016

Event Type  Injury  

Manufacturer Narrative

(b)(4).Concomitant medical device: m2a-magnum pf cup 50odx44id # item us157850, lot 580400; m2a-magnum mod hd sz 44mm # item 157444, lot 593770; bi-metric/x por nc 11x135 # item x180311, lot 420310.Multiple reports have been submitted for this event.Please see associated reports: 0001825034-2018-10147, 0001825034-2018-10148, 0001825034-2018-10149.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

It was reported that the patient was revised approximately 9 years post initial surgery due to sepsis and pseudotumor.Head was revised.Attempts to obtain additional information have been made; however, no more is available.

Manufacturer Narrative

This follow-up report is being submitted to relay additional information.Reported event was confirmed by review of revision op notes.Revision op notes states that the ct scan revealed swelling, thickening and fluid collection around the right hip as well as a large supraacetabular osteolytic defect.Patient showing signs of systemic sepsis with positive blood cultures with gram-positive cocci.He has a history of methicillin-resistant staphylococcus epidermidis (mrse).Large amount of purulent fluid in posterior aspect of hip joint.Capsulectomy and excision of heterotropic bone performed anteriorly.Device history record was reviewed and no discrepancies were found.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.

Event Description

No further event information available at the time of this report.

• Brand Name: M2A-MAGNUM 42-50MM TPR INSRT-6
• Type of Device: PROSTHESIS HIP
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• MDR Report Key: 8199249
• MDR Text Key: 131494553
• Report Number: 0001825034-2018-11473
• Device Sequence Number: 1
• Product Code: KWA
• 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: 05/01/2019

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?: No
• Device Operator: Health Professional
• Device Expiration Date: 05/28/2017
• Device Model Number: N/A
• Device Catalogue Number: 139252
• Device Lot Number: 744130
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 12/03/2018
• Initial Date FDA Received: 12/27/2018
• Supplement Dates Manufacturer Received: 04/17/2019
• Supplement Dates FDA Received: 05/01/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 41 YR