MAUDE Adverse Event Report: ZIMMER BIOMET, INC. M2A 1 PC SHELL 38MMX52MM; PROSTHESIS HIP

Model Number N/A

Device Problem Insufficient Information (3190)

Patient Problems Necrosis (1971); Pain (1994); Reaction (2414)

Event Date 03/09/2017

Event Type  Injury  

Manufacturer Narrative

(b)(4).Concomitant medical products: 11-173662, m2a 38mm mod hd std nk, 953100; x11-180314, bi-metric/x por nc lat 14x150, 744210.Multiple mdr reports were filed for this event, please see associated reports: 0001825034-2018-09432.It is unknown if product will be returning to zimmer biomet and the investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.

Event Description

It was reported that the patient underwent a revision approximately 12 years post initial surgery due to pain and metallosis.During the surgery, surgeon observed typical metal-metal disease look in fluid that was discovered when a large bursa was incised and it was also noted that there was severe abductor avulsion and necrosis involvement with pseudotumor infiltration.Head and shell were revised.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.Reported event was confirmed by review of revision op notes.Revision op notes dated were provided and identified patient was revised due to failed tha secondary to metal - metal disease with pain and elevated ions.There was a large bursa full of fluid.When this was incised, it was under pressure and approximately 40-50 ml of milky fluid expressed.Typical metal-metal disease look.There was noted to be severe abductor avulsion and necrosis involvement with pseudotumor infiltration.There were moderate corrosion changes about the head and neck junction.There was significant bone loss around the acetabulum.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.

• Brand Name: M2A 1 PC SHELL 38MMX52MM
• Type of Device: PROSTHESIS HIP
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• MDR Report Key: 8201030
• MDR Text Key: 131647218
• Report Number: 0001825034-2018-09431
• Device Sequence Number: 1
• Product Code: KWA
• Combination Product (y/n): N
• PMA/PMN Number: K011110
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,health profession
• Type of Report: Initial,Followup
• Report Date: 04/16/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/27/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 08/30/2015
• Device Model Number: N/A
• Device Catalogue Number: 15-105052
• Device Lot Number: 761390
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 04/12/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention