MAUDE Adverse Event Report: ZIMMER BIOMET, INC. M2A-MAGNUM MOD HD SZ 52MM; PROSTHESIS, HIP

Model Number N/A

Device Problems Degraded (1153); Material Erosion (1214); Unintended Movement (3026)

Patient Problems Ossification (1428); Adhesion(s) (1695); Pain (1994); Loss of Range of Motion (2032); Local Reaction (2035); Unspecified Tissue Injury (4559)

Event Date 02/22/2021

Event Type  Injury  

Manufacturer Narrative

(b)(4).Item #: unknown cup lot #: unknown.Item #: unknown stem lot #: unknown.Customer has indicated that the product will not be returned to zimmer biomet for investigation.The product location is unknown.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: 0001825034-2022-00357.

Event Description

It was reported that patient underwent an initial right total hip arthroplasty, subsequently was revised twelve years post initial implant due to pain.During the revision noted altr, impingement, limited mobility, ho and scar tissue.The head, neck and acetabulum were exchanged without difficulty.The stem remained implanted.Attempts have been made and no further information has been provided.

Manufacturer Narrative

(b)(4).Concomitant products: item #: unknown cup lot #: unknown.Item #: unknown stem lot #: unknown.Customer has indicated that the product will not be returned to zimmer biomet for investigation.The product location is unknown.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: 0001825034-2022-00357.

Event Description

It was reported that patient underwent an initial right total hip arthroplasty, subsequently was revised twelve years post initial implant due to pain.During the revision noted altr, impingement, limited mobility, ho and scar tissue.The head, neck and acetabulum were exchanged without difficulty.The stem remained implanted.Attempts have been made and no further information has been provided.

Manufacturer Narrative

(b)(4).D10: 139264 m2a-magnum 52-60mm tpr insrt 519960.11-103208 taperloc por lat fmrl 15x150 269860.Us157858 m2a-magnum pf cup 58odx52id 720460.Reported event was confirmed by review of medical records.Device history record (dhr) was reviewed and no discrepancies were found.Root cause was unable to be determined.Medical records identified the following: pain with aseptic failure of hip.Moderate fluid with metalotic tinging, removal of thick fibrotic avascular tissue with acute local tissue reaction.Greater trochanteric impingement with loss of motion.Trochanteric ostectomy to the anterior column to stabilize the hip.Heterotopic ossification and thick fibrotic scar tissue.If any further information is found which would change or alter any conclusions or information, a supplemental report 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 52MM
• 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: 13536319
• MDR Text Key: 285634285
• Report Number: 0001825034-2022-00358
• 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,Distributor
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 03/21/2022

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: 08/31/2019
• Device Model Number: N/A
• Device Catalogue Number: 157452
• Device Lot Number: 649260
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 02/03/2022
• Initial Date FDA Received: 02/15/2022
• Supplement Dates Manufacturer Received: 03/14/2022
• Supplement Dates FDA Received: 03/21/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/01/2009
• 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): Required Intervention; Hospitalization
• Patient Sex: Male