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

Model Number N/A

Device Problems Material Erosion (1214); Unstable (1667)

Patient Problems Erosion (1750); Pain (1994); Tissue Damage (2104); Osteolysis (2377); Reaction (2414)

Event Date 04/22/2019

Event Type  Injury  

Manufacturer Narrative

(b)(4).Concomitant medical products: biomet m2a magnum pf cup us157852 lot 199420.Biomet mallory head pf femoral 11-104111, lot 660430.Biomet m2a magnum taper adapter, 139258, lot 021590.The device will not be returned for analysis, due to location of device is unknown; however, an investigation of the reported event is in progress.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: 0001825034-2020-01416, 0001825034-2020-01417.

Event Description

It was reported a patient had an initial right.Subsequently, the patient was revised approximately 13 years later due to pain, instability, metallosis, loosening, tissue damage, elevated metal ion levels, osteolysis, and bone erosion.Medical records received and reviewed indicate the following: gross loosening of the acetabular cup with partial disruption of the abductor mechanism; metallosis identified; the patient presented with progressing pain and instability; the abductor had partially detached from the anterior third at the greater trochanter; some osteolysis noted around the proximal femur-stem well fixed.During the revision, devices were implanted to provide greater stability.The abductors were also repaired prior to closure.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.The following sections were updated/corrected.Updated: d4; h2; h3; h4; h6.Reported event was confirmed with medical records provided.Review of the available records identified the following: failed right tha with gross loosening of the acetabular compartment, partial disruption of the abductor mechanism, and metallosis.Progressively worsening pain and instability.X rays showed progressive protrusion of the acetabulum.There were elevated ions on laboratory testing (no report provided).Abductor partially detached off the anterior third at the greater trochanter.There was some osteolysis around the proximal femur but the stem was well fixed.The acetabular component was grossly loose.Review of the device history record(s) identified no deviations or anomalies during manufacturing.A definitive root cause cannot 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-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: 9920807
• MDR Text Key: 188482406
• Report Number: 0001825034-2020-01415
• 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: 08/07/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/03/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 04/30/2016
• Device Model Number: N/A
• Device Catalogue Number: 157446
• Device Lot Number: 342860
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 08/03/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Treatment: SEE H10 NARRATIVE
• Patient Outcome(s): Hospitalization; Required Intervention