MAUDE Adverse Event Report: ZIMMER BIOMET, INC. M2A TPR HI CARBON 41/32MM LNR; PROSTHETIC, HIP

Model Number N/A

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

Patient Problems Host-Tissue Reaction (1297); Local Reaction (2035)

Event Date 12/17/2020

Event Type  Injury  

Manufacturer Narrative

(b)(4).The device will not be returned for analysis as location is unknown; however, an investigation of the reported event is in progress.Once the investigation is completed, a supplemental mdr will be submitted.Multiple mdr reports were filed for this event, please see associated reports: 0001825034 - 2020 - 04450 0001825034 - 2020 - 04452.

Event Description

It was reported the patient underwent a revision surgery on suspicion of pseudotumor 11 years after initial implantation.Attempts have been made and additional information on the reported event is unavailable at this time.

Manufacturer Narrative

   no product was returned or pictures provided; visual and dimensional evaluations could not be performed.A review of the device history records identified deviations or anomalies during manufacturing, the deviations or anomalies would not have attributed to the event.Medical records were not provided.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.

Event Description

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

• Brand Name: M2A TPR HI CARBON 41/32MM LNR
• Type of Device: PROSTHETIC, HIP
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• MDR Report Key: 11110929
• MDR Text Key: 225043416
• Report Number: 0001825034-2020-04451
• 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: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 05/11/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/04/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 11/30/2018
• Device Model Number: N/A
• Device Catalogue Number: 15-105044
• Device Lot Number: 417800
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 05/10/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Treatment: ITEM#10-104052 NAMEM2A-T M/H RAD SHL LOT#249640
• Patient Outcome(s): Hospitalization; Required Intervention