MAUDE Adverse Event Report: ZIMMER BIOMET, INC. 32MM M2A HI CARBON HD -3MM NK; PROSTHESIS, HIP

Model Number N/A

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Local Reaction (2035)

Event Date 02/12/2021

Event Type  Injury  

Manufacturer Narrative

(b)(4).Foreign: (b)(6).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: 0001825034-2021-01439.

Event Description

It was reported that the patient underwent a revision procedure approximately 10 years and 3 months post implantation due to suspicion of pseudotumor.Attempts have been made and additional information on the reported event is unavailable at this time.

Event Description

No further event information available at the time of this report.

Manufacturer Narrative

The event was confirmed with photographs received.Visual examination of the provided pictures identified head and taper liner with scratches on the surface of the head.The taper of the head has black spots.It is unknown what the spots are.No other evaluation can be made.Device history record 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.

• Brand Name: 32MM M2A HI CARBON HD -3MM NK
• Type of Device: PROSTHESIS, HIP
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• MDR Report Key: 11812834
• MDR Text Key: 250228182
• Report Number: 0001825034-2021-01440
• Device Sequence Number: 1
• Product Code: KWY
• Combination Product (y/n): N
• PMA/PMN Number: K003363
• 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: 09/02/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/12/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 05/28/2018
• Device Model Number: N/A
• Device Catalogue Number: 11-163687
• Device Lot Number: 658860
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 09/01/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Treatment: CAT#:15-105044 M2A LINER LOT#: 478250; CAT#:15-105044 M2A LINER LOT#: 478250
• Patient Outcome(s): Hospitalization; Required Intervention