MAUDE Adverse Event Report: ZIMMER BIOMET, INC. M2A-MAGNUM MOD HD SZ 46MM; PROSTHESIS, HIP

Model Number N/A

Device Problems Material Erosion (1214); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Cyst(s) (1800); Pain (1994); Tissue Damage (2104); Reaction (2414)

Event Date 05/22/2018

Event Type  Injury  

Manufacturer Narrative

(b)(4).Concomitant medical product(s): 139256 m2a-magnum 42-50 tpr insrt 871530; 103206 taperloc por fmrl 12.5x145 007640; us157852 m2a-magnum pf cup 52odx46id 534520.Customer has indicated that the product will not be returned to zimmer biomet for investigation.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 - 2019 - 04380 ,cup.

Event Description

It was reported that the patient underwent an initial right hip arthroplasty and subsequently was revised due metallosis six years later.Attempts were made to obtain additional information; however, none was available.

Manufacturer Narrative

(b)(4).This follow-up report is being submitted to relay additional information.Reported event was confirmed by review of medical records and radiographs.Device history record (dhr) was reviewed and no discrepancies were found.Root cause was unable to be determined.Medical records/radiographs were provided and reviewed by a health care professional and identified the following: failed mom tha w/metallosis.R gluteus medius tear.Ebl: 300ml.Painful r hip, elevated serum co and cr, large effusion possibly indicating non-healing of abductors.Acetabular component noted to be in 60-65 degrees of abduction and is retroverted via preoperative radiograph.Prior incision utilized.Bald anterior greater trochanter indicating non-healing of previous abductor repair vs.Tear.Anterior third of gluteus medius tendon was not healed.Dark metallosis-tinged fluid within joint.Capsule stained dark w/metal debris.No signs of trunnionosis.Stem appeared well-fixed and in relative retroversion, 0-5 degrees anteversion.Metal cup was facing directly superior indicating severe retroversion and excessive abduction.Removed w/minimal bone loss.Noted large central cyst, possibly d/t stress shielding.Pt deficient of bone posteriorly, reamed to 57 but trial had poor purchase.15ml crushed cancellous allograft place and packed into the cyst.58mm trident shell placed in 30 degrees anteversion and 40 degrees abduction.Two 35mm screws utilized and liner placed.Osteophyte removed from anterior rim.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.

Manufacturer Narrative

(b)(4).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 the patient underwent a primary.The patient underwent a revision six years later due to pain, metallosis, elevated metal ions, tissue damage and migration of the shell.

Manufacturer Narrative

(b)(4).D4: 00880304427808.Reported event was unable to be confirmed due to limited information received from the customer.Device history record (dhr) 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 MOD HD SZ 46MM
• Type of Device: PROSTHESIS, HIP
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• MDR Report Key: 9139962
• MDR Text Key: 165117942
• Report Number: 0001825034-2019-04381
• Device Sequence Number: 1
• Product Code: JDI
• 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,distributor,health p
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 06/03/2020

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: 01/31/2021
• Device Model Number: N/A
• Device Catalogue Number: 157446
• Device Lot Number: 638070
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 09/12/2019
• Initial Date FDA Received: 10/01/2019
• Supplement Dates Manufacturer Received: 01/30/2020; 02/14/2020; 06/03/2020
• Supplement Dates FDA Received: 02/06/2020; 03/10/2020; 06/04/2020
• 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