MAUDE Adverse Event Report: ZIMMER BIOMET, INC. M2A 38MM MOD HD+6MM NK NO SKRT; PROSTHESIS, HIP

Model Number N/A

Device Problems Material Erosion (1214); Noise, Audible (3273)

Patient Problems Failure of Implant (1924); Necrosis (1971); Pain (1994); No Code Available (3191); Metal Related Pathology (4530)

Event Date 10/12/2020

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 remains implanted.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.Unique identifier (udi) #: n/a.Concomitant medical products: rd118856, cup, lot # 485271.11-162613, integral lat por 13x145mm, lot # 593320.Multiple mdr reports were filed for this event; please see associated reports: 0001825034-2018-11508.

Event Description

It was reported that approximately 16 years post implantation of the l hip, the patient has been experiencing pain, elevated metal ion levels, audible noise, and metal taste in mouth.Attempts have been made and no further information has been provided.

Manufacturer Narrative

(b)(4).This follow-up report is being submitted to relay additional information.  reported event was confirmed by review of lab reports which indicated results: chromium 11.6; cobalt: 32.3.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.H6: component code: mechanical (g04) ¿ head.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

It was reported that patient underwent a left hip revision approximately 20 years post implantation due to pain, elevated metal ion levels, noise, metal taste in mouth, metallosis, pseudotumor, metal tissue staining, and inflammatory tissue.Attempts have been made and no additional information is available at this time.

Event Description

No additional event information to report at this time.

Manufacturer Narrative

This follow-up report is being submitted to relay additional information.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: M2A 38MM MOD HD+6MM NK NO SKRT
• 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: 8200315
• MDR Text Key: 131532648
• Report Number: 0001825034-2018-11507
• Device Sequence Number: 1
• Product Code: KWA
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K011110
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Consumer
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 01/31/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/27/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 12/31/2011
• Device Model Number: N/A
• Device Catalogue Number: 11-173664
• Device Lot Number: 703940
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 01/27/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/07/2001
• 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): Required Intervention; Other; Hospitalization
• Patient Sex: Male
• Patient Weight: 86 KG