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

Model Number N/A

Device Problem Material Erosion (1214)

Patient Problems Pain (1994); Metal Related Pathology (4530); Swelling/ Edema (4577)

Event Date 10/01/2020

Event Type  Injury  

Manufacturer Narrative

(b)(4).Concomitant medical products: catalog number:us157852 lot number:213320 brand name: m2a-magnum pf cup, catalog number:157446 lot number: 368600 brand name:m2a-magnum mod hd, catalog number:139252 lot number:688380 brand name: m2a-magnum 42-50mm, catalog number:192413 lot number: 607420 brand name: echo por fmrl red.Multiple reports were submitted along with this report 0001825034-2022-00633, 0001825034-2022-00634 and 0001825034-2022-00635.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.

Event Description

It was reported that the patient was revised due to pain, effusion and metallosis approximately 10 years post implantation.Additional information on the reported event is unavailable.

Event Description

No additional information on the reported event.

Manufacturer Narrative

This follow-up report is being submitted to relay additional information.Reported event was confirmed via medical records reviewed by a health care professional.No product was returned or pictures provided; visual and dimensional evaluations could not be performed.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 42-50MM 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: 13860929
• MDR Text Key: 287684726
• Report Number: 0001825034-2022-00635
• 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: 04/18/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/23/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/31/2020
• Device Model Number: N/A
• Device Catalogue Number: 139252
• Device Lot Number: 688380
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 04/12/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/01/2010
• 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: Female