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

Model Number N/A

Device Problem Difficult or Delayed Separation (4044)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 06/09/2021

Event Type  Injury  

Event Description

It was reported patient underwent a left hip revision approximately 12 years post implantation due to pain, elevated metal ions, and altr that was noted in mri.During the procedure the surgeon noted difficulty disengaging the stem from the head neck combination, as it was cold welded.Surgeon was finally able to disengage the implants.The stem was retained.Attempts have been made and additional information on the reported event is unavailable at this time.

Manufacturer Narrative

(b)(4).Concomitant products: unknown-unknown m2a head-unknown ; unknown-unknown m2a cup-unknown ; unknown-unknown stem-unknown.Multiple mdr reports were filed for this event, please see associated reports: 0001825034 - 2021 - 03067, 0001825034 - 2021 - 03068, 0001825034 - 2021 - 03071.Customer has indicated that the product will not be returned to zimmer biomet for investigation, product location unknown.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.Device location is unknown.

Manufacturer Narrative

This follow-up report is being submitted to relay additional information.Reported event was confirmed via medical records and radiographs reviewed by a health care professional.Part and lot identification are necessary for review of device history records, neither were provided.No product was returned; visual and dimensional evaluations could not be performed.A definitive root cause could not 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 additional information on the reported event.

Manufacturer Narrative

This follow-up report is being submitted to relay additional information.The following sections were updated/corrected updated: b7; d6a; g3; h2.Corrected: d6a.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: UNKNOWN M2A TAPER ADAPTER
• 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: 12781019
• MDR Text Key: 281396453
• Report Number: 0001825034-2021-03069
• Device Sequence Number: 1
• Product Code: LPH
• 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,Distributor
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 07/08/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• 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
• Initial Date Manufacturer Received: 10/18/2021
• Initial Date FDA Received: 11/09/2021
• Supplement Dates Manufacturer Received: 11/23/2021; 06/28/2022
• Supplement Dates FDA Received: 11/24/2021; 07/08/2022
• 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: NI
• Patient Sequence Number: 1
• Treatment: SEE H10
• Patient Sex: Male