MAUDE Adverse Event Report: ZIMMER BIOMET, INC. UNKNOWN M2A TAPER PROSTHESIS, HIP

Model Number N/A

Device Problem Corroded (1131)

Patient Problems Failure of Implant (1924); Scar Tissue (2060); Metal Related Pathology (4530)

Event Date 03/01/2021

Event Type  Injury  

Manufacturer Narrative

(b)(4). Customer has indicated that the product will not be returned to zimmer biomet for the investigation as 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 - 2022 - 00383, 0001825034 - 2022 - 00384, 0001825034 - 2022 - 00387.

Event Description

It was reported that patient underwent a right hip revision approximately 13 years post implantation due to metallosis, altr, loosening of the cup, and scar tissue. During the surgery, black synovial tissue and corrosion on the trunnion were noted. The head, cup and taper were removed and replaced. The stem was left intact. Attempts have been made and additional information on the reported event is unavailable at this time.

Manufacturer Narrative

(b)(4). Customer has indicated that the product will not be returned to zimmer biomet for the investigation as 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 - 2022 - 00383, 0001825034 - 2022 - 00384, 0001825034 - 2022 - 00387.

Event Description

It was reported that patient underwent a right hip revision approximately 13 years post implantation due to metallosis, altr, loosening of the cup, and scar tissue. During the surgery, black synovial tissue and corrosion on the trunnion were noted. The head, cup and taper were removed and replaced. The stem was left intact. Attempts have been made and additional information on the reported event is unavailable at this time.

• Brand Name: UNKNOWN M2A TAPER
• 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: 13584693
• MDR Text Key: 286043421
• Report Number: 0001825034-2022-00386
• Device Sequence Number: 1
• Product Code: KWA
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: NI
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Consumer,Health Professional,Company Representative

Reporter Occupation

• Type of Report: Initial,Followup
• Report Date: 03/14/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/23/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes

Device Operator

• Device Model Number: N/A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 03/11/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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 Treatment Data

Date Received: 02/23/2022 Patient Sequence Number: 1