MAUDE Adverse Event Report: ZIMMER BIOMET, INC. M2A-MAGNUM PF CUP 54ODX48ID; PROSTHESIS, HIP

Model Number N/A

Device Problem Material Erosion (1214)

Patient Problems Pain (1994); Scar Tissue (2060); Tissue Damage (2104); Reaction (2414)

Event Date 09/21/2017

Event Type  Injury  

Manufacturer Narrative

(b)(4).Reported event was confirmed by revision operative notes.Revision op notes demonstrated that the patient was revised due to pain and elevated metal ion levels.During the revision, the cup was found minimally anteverted, but still great stability through a functional range of motion.New dual mobility liner, ceramic head, taper adapter were implanted with existing cup and stem.The hip was reduced and found stable.Review of the device history record identified no deviations or anomalies would contribute to reported event.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

It was reported patient¿s left hip was revised approximately 10 years post implantation due to elevated metal ion levels, with metallosis.No further event information available at the time of this report.

• Brand Name: M2A-MAGNUM PF CUP 54ODX48ID
• Type of Device: PROSTHESIS, HIP
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• Manufacturer (Section G): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• Manufacturer Contact: christina arnt ; 56 e. bell dr.; warsaw, IN 46582 ; 5745273773
• MDR Report Key: 9271408
• MDR Text Key: 164816327
• Report Number: 0001825034-2019-04783
• Device Sequence Number: 1
• Product Code: KWY
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K101336
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 10/22/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/04/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 08/31/2017
• Device Model Number: N/A
• Device Catalogue Number: US157854
• Device Lot Number: 814790
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 10/16/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/04/2007
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Treatment: 11-103201 634510 TAPERLOC POR LAT FMRL6.0X132; 139254 549070 M2A-MAGNUM 42-50MM TPRINSRT-3; BIOMET HEAD CAT#157448 LOT#363240
• Patient Outcome(s): Hospitalization; Required Intervention