MAUDE Adverse Event Report: ZIMMER BIOMET, INC. M2A-MAGNUM MOD HD SZ 42MM; PROSTHESIS, HIP

Model Number N/A

Device Problems Material Erosion (1214); Loosening of Implant Not Related to Bone-Ingrowth (4002)

Patient Problems Metal Related Pathology (4530); Muscle/Tendon Damage (4532)

Event Date 03/22/2023

Event Type  Injury  

Manufacturer Narrative

(b)(4).Multiple mdr reports were filed for this event, please see associated reports: 0001825034 - 2024 - 00210 0001825034 - 2024 - 00207 0001825034 - 2024 - 00208.The customer has indicated that the product will not be returned to zimmer biomet for investigation as its location is unknown.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.

Event Description

It was reported that a patient underwent a left hip revision approximately fourteen years post implantation due to mechanical loosening and metallosis.During the revision surgery, a large amount of metallosis was encountered throughout the soft tissues and hip joint, along with destruction of the anterior capsule, posterior capsule, and abductor muscle.Both the femoral component and the acetabular component were found not loose.The stem and cup remained implanted.The head and taper adapter were explanted.A new head, liner, and taper adapter were implanted.Attempts have been made and no further information has been provided.

Manufacturer Narrative

This follow-up report is being submitted to relay additional information.The following sections were updated: b4; g3; h2; h3; h6.H6: component code: mechanical (g04) - head.No product was returned, or pictures provided; visual and dimensional evaluations could not be performed.A review of the device history records identified no deviations or anomalies during manufacturing.The reported products were reviewed for compatibility with no issues noted.Medical records/radiographs were provided and reviewed by a health care professional.A review of the available records identified findings of the reported issues: spinal anesthesia, ebl 100ml, posterolateral approach, large amount of metallosis seen throughout the soft tissues around the hip extending distally and into the hip joint, the anterior and posterior capsules were both destroyed from metal debris, 50% of the abductor muscle was destroyed, femoral head removed, trunnion intact, acetabular component well preserved and intact; ¿both femoral component and acetabular component were not loose,¿ mechanical loosening of internal left hip prosthesis, metallosis with debridement, and no intra-operative complications/events.The reported issue was confirmed via medical records; however, 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.

Event Description

No further event information is available at the time of this report.

• Brand Name: M2A-MAGNUM MOD HD SZ 42MM
• Type of Device: PROSTHESIS, HIP
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; p.o. box 587; warsaw IN 46581
• Manufacturer (Section G): ZIMMER BIOMET, INC.; 56 e. bell drive; p.o. box 587; warsaw IN 46581
• Manufacturer Contact: jennifer rapsavage ; 56 e. bell dr.; warsaw, IN 46582 ; 5745260384
• MDR Report Key: 18608583
• MDR Text Key: 334113641
• Report Number: 0001825034-2024-00206
• Device Sequence Number: 1
• Product Code: KWA
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K042037
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Consumer,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 05/16/2024

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: Lay User/Patient
• Device Expiration Date: 10/31/2018
• Device Model Number: N/A
• Device Catalogue Number: 157442
• Device Lot Number: 058400
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 01/08/2024
• Initial Date FDA Received: 01/30/2024
• Supplement Dates Manufacturer Received: 05/15/2024
• Supplement Dates FDA Received: 05/16/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/01/2008
• 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
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Sex: Female