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

Model Number N/A

Device Problem Material Erosion (1214)

Patient Problems Pain (1994); Loss of Range of Motion (2032); Metal Related Pathology (4530); Unspecified Tissue Injury (4559)

Event Date 03/11/2021

Event Type  Injury  

Manufacturer Narrative

(b)(4).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 - 2021 - 02939, 0001825034 - 2021 - 02940.

Event Description

It was reported that the patient underwent a right hip revision.Subsequently, patient started experiencing pain and was revised approximately 15 years later due to pain, tenderness, fluid collection, and decreased mobility.Attempts have been made and additional information on the reported event is unavailable at this time.

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 no product was returned or pictures provided; visual and dimensional evaluations could not be performed.Medical records were not provided.Review of the device history records identified no deviations or anomalies during manufacturing.Root cause was unable to be determined as the necessary information to adequately investigate the reported event was not provided.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 available at the time of this report.

Manufacturer Narrative

This follow-up report is being submitted to relay additional information.

Event Description

It was reported that the patient underwent a right hip revision.Subsequently, patient started experiencing pain and was revised approximately 15 years later due to pain, metallosis, and elevated metal ions.During the revision, soft tissue capsular damage was noted as well as staining on the trunnion.The head was replaced with a dual mobility construct without complication.No further event information available at the time of this report.

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: h2 medical records/radiographs were provided and reviewed by a health care professional.A review of the available records identified findings of the reported issues clinical and radiographic symptoms consistent with metallosis, elevated ions as reported, damage to the capsular tissue, mild staining on the trunnion within the joint of femoral head.Cup and stem well fixed.No further complications, the additional information does not change the outcome of the previous investigation.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.

Manufacturer Narrative

This follow-up report is being submitted to relay additional information.The following sections were updated/corrected updated: d9; h2; h3 device was returned and evaluated against the complaint.Visual inspection found surface scuffing on the outer radius.Dried debris was also observed on the outer radius.The additional information does not change the outcome of the previous investigation.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 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; 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: 12696199
• MDR Text Key: 278326202
• Report Number: 0001825034-2021-02938
• 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
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date: 09/07/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/26/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 05/31/2015
• Device Model Number: N/A
• Device Catalogue Number: 157442
• Device Lot Number: 210200
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 09/02/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/01/2005
• 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: CAT#162308 BIOMET STEM LOT#277250; CAT#162308 BIOMET STEM LOT#277250
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 51 YR
• Patient Sex: Female