MAUDE Adverse Event Report: ZIMMER BIOMET, INC. M2A MAGNUM 42-50M TPR INSRT +6; PROSTHESIS, HIP

Model Number N/A

Device Problem Material Erosion (1214)

Patient Problems Erosion (1750); Bone Fracture(s) (1870); Failure of Implant (1924); Osteolysis (2377); Metal Related Pathology (4530)

Event Date 11/07/2019

Event Type  Injury  

Manufacturer Narrative

(b)(4).Concomitant medical products: catalog#: 157446 m2a-magnum mod hd sz 46mm lot#: 908140, catalog#: us157852 m2a-magnum pf cup 52odx46id lot#: 496100, catalog#: x11-180311 bi-metric/x por nc lat 11x135 lot#: 026860.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: 0001825034-2022-00704, 0001825034-2022-00705, 0001825034-2022-00707.

Event Description

It was reported that the patient underwent a revision procedure of the left hip approximately eleven (11) years post implantation due to metallosis, osteolysis, pseudotumor, and a trochanteric fracture.Attempts have been made and additional information on the reported event is unavailable at this time.

Event Description

It was reported that the patient underwent a revision procedure of the left hip approximately eleven 11 years post implantation due to metallosis, osteolysis, pseudotumor, and a trochanteric fracture.During the revision, the shell was found grossly loose, the trunnion was cold welded, and multiple bony defects in the femur and acetabulum were encountered.The eroded and nonunionized trochanteric fracture was repaired with cerclage cables.All implants were replaced with competitor product.No further event information available at the time of this report.

Manufacturer Narrative

This follow-up report is being submitted to relay additional information.Medical records were provided and reviewed by a health care professional.Review of the available records identified the following: metallosis with pseudotumor, chronic trochanteric fracture left hip, severe osteolysis of the proximal femur and acetabulum, damaged femoral trunnion.Unable to dislodge the female side of the trunnion, stem removed with burs and osteotomes, significant defects noted.Shell grossly loose, severe osteolytic defects behind the cup, packed with bone graft.Bone soft and osteopenic.Chronic defect of his trochanter with eroded bone and chronic fibrous nonunion of his trochanteric fracture, secured with cerclage cables.Device history record was reviewed and no discrepancies relevant to the reported event were found.Root cause was unable to be determined.No problem with the device was found.Upon reassessment of the reported event, the m2a magnum 42-50m tpr insrt +6 was determined to be not reportable.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 42-50M TPR INSRT +6
• 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: 13934828
• MDR Text Key: 288098534
• Report Number: 0001825034-2022-00706
• Device Sequence Number: 1
• Product Code: LPH
• 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,Followup
• Report Date: 05/09/2022

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: 05/31/2018
• Device Model Number: N/A
• Device Catalogue Number: 139259
• Device Lot Number: 036980
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 03/10/2022
• Initial Date FDA Received: 03/29/2022
• Supplement Dates Manufacturer Received: 04/19/2022
• Supplement Dates FDA Received: 05/09/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/01/2008
• 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
• Treatment: SEE H10 NARRATIVE
• Patient Outcome(s): Required Intervention; Hospitalization
• Patient Age: 46 YR
• Patient Sex: Male