MAUDE Adverse Event Report: ZIMMER BIOMET, INC. M2A 38MM MOD HD STD NK; PROSTHESIS, HIP

Catalog Number 11-173662

Device Problems Corroded (1131); Material Erosion (1214)

Patient Problem No Code Available (3191)

Event Date 03/06/2017

Event Type  Injury  

Manufacturer Narrative

(b)(4).Concomitant medical products: rd118854-m2a cup-431590, 112094- impact metaphyseal-479160, 11-112013-r/h impact distal- 773050.Multiple mdr reports were filed for this event, please see associated reports: 0001825034 -2019 -05630, 0001825034 -2019 -05642.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.Device location unknown.

Event Description

It was reported that a patient underwent a left hip arthroplasty.Subsequently, the patient underwent bilateral hip revision 14 years post-op due to elevated metal ion levels.While revising the left side, clear joint fluid was encountered with black trunnionosis.The trunnion was cleaned and dried, and a dual mobility head and liner combination was placed without complication.Attempts have been made and additional information on the reported event is unavailable 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 patient underwent a revision surgery due to elevated metal ion levels.During the surgery, trunnionosis was found about the head and stem.Dhr was reviewed and no discrepancies were found.The root cause is 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 additional event information to report at this time.

• Brand Name: M2A 38MM MOD HD STD NK
• Type of Device: PROSTHESIS, HIP
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• MDR Report Key: 9494514
• MDR Text Key: 172807966
• Report Number: 0001825034-2019-05625
• Device Sequence Number: 1
• Product Code: LZO
• Combination Product (y/n): N
• PMA/PMN Number: K062997
• 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: 04/01/2020

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
• Device Expiration Date: 05/28/2013
• Device Catalogue Number: 11-173662
• Device Lot Number: 421550
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 11/25/2019
• Initial Date FDA Received: 12/19/2019
• Supplement Dates Manufacturer Received: 03/31/2020
• Supplement Dates FDA Received: 04/03/2020
• 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