MAUDE Adverse Event Report: ZIMMER BIOMET, INC. M2A-MAGNUM PF CUP 50ODX44ID; PROSTHESIS, HIP

Model Number N/A

Device Problem Material Erosion (1214)

Patient Problem Reaction (2414)

Event Date 09/10/2020

Event Type  Injury  

Manufacturer Narrative

(b)(4).11-104331 mlry-hd xr lat por fmrl 11mm 109030 139254 m2a-magnum 42-50mm tpr insrt-3 249350 157444 m2a-magnum mod hd sz 44mm 407920.(b)(6).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: 0001825034-2020-03562.

Event Description

It was reported patient underwent hip revision approximately nine years post implantation due to metallosis.During the procedure, metallosis was noted, all components were removed and replaced.Attempts have been made and additional information on the reported event is unavailable at this time.

Manufacturer Narrative

(b)(4).This follow-up report is being submitted to relay additional information.Reported event was unable to be confirmed due to limited information received from the customer.Device history record (dhr) was reviewed and no discrepancies 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 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 PF CUP 50ODX44ID
• Type of Device: PROSTHESIS, HIP
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• MDR Report Key: 10553975
• MDR Text Key: 207548343
• Report Number: 0001825034-2020-03561
• Device Sequence Number: 1
• Product Code: LPH
• Combination Product (y/n): N
• PMA/PMN Number: K101336
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,foreign,health pr
• Type of Report: Initial,Followup
• Report Date: 11/24/2020

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: 09/30/2020
• Device Model Number: N/A
• Device Catalogue Number: US157850
• Device Lot Number: 325400
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 09/11/2020
• Initial Date FDA Received: 09/18/2020
• Supplement Dates Manufacturer Received: 11/19/2020
• Supplement Dates FDA Received: 11/24/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Treatment: SEE H10
• Patient Outcome(s): Hospitalization; Required Intervention