MAUDE Adverse Event Report: ZIMMER BIOMET, INC. M2A-MAGNUM MOD HD SZ 50MM; HIP PROSTHESIS

Model Number N/A

Device Problems Material Erosion (1214); Insufficient Information (3190)

Patient Problems Local Reaction (2035); Osteolysis (2377); Reaction (2414)

Event Date 04/24/2018

Event Type  Injury  

Manufacturer Narrative

(b)(4).Customer has indicated that the product will not be returned to zimmer biomet for investigation, as the device location is unknown.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.Concomitant medical products: item # us257856, magnum trispike cup, lot # 264460; item #139252, m2a-magnum 42-50mm tpr insrt-6, lot # 920510; item #11-10421, mlry-hd lat por fmrl, lot # 303380.

Event Description

It was reported that a patient was revised approximately 10 years post implantation due to metallosis, elevated ion levels, altr and osteolysis.Operative notes indicated: upon entering the fascia lata, the patient did have some metallosis on his tissues; they were debrided; reactive tissue in the hip at this time as well.Attempts have been made, and no further information has been provided.

Manufacturer Narrative

Reported event was confirmed by review of medical records.Device history record (dhr) was reviewed and no discrepancies relevant to the reported event were found.Root cause was unable to 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 available at the time of this report.

Manufacturer Narrative

This follow-up report is being submitted to relay additional information.Complaint sample was evaluated and the reported event was confirmed.Visual examination of the returned product identified scuffing and scratching on the outer radius of the head.Gouges and dings are present on the rim.The taper insert was also returned.The exposed face is dinged and deformed.Light debris is present inside the taper.Device history record (dhr) was reviewed and no discrepancies were found.Root cause was unable to be determined.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 50MM
• Type of Device: HIP PROSTHESIS
• 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: 8206309
• MDR Text Key: 131722080
• Report Number: 0001825034-2018-11522
• Device Sequence Number: 1
• Product Code: KWY
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K833175
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Distributor
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 04/26/2022

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: 11/30/2017
• Device Model Number: N/A
• Device Catalogue Number: 157450
• Device Lot Number: 563840
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 12/06/2018
• Initial Date FDA Received: 12/31/2018
• Supplement Dates Manufacturer Received: 02/07/2019; 04/20/2022
• Supplement Dates FDA Received: 02/12/2019; 04/26/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/26/2007
• 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.
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Sex: Male