MAUDE Adverse Event Report: ZIMMER BIOMET, INC. UNKNOWN MODULAR TAPER LOCKED FEMORAL POROUS COATED STEM 9X137MM; PROSTHESIS, HIP

Model Number N/A

Device Problem Separation Failure (2547)

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

Event Date 06/09/2021

Event Type  Injury  

Event Description

It was reported that there was an attempt to revise the head due to elevated metal ion levels and prominent metallosis.The revision did not proceed as they were unable to remove the femoral head from the trunnion due to presumed cold welding.Attempts have been made and additional information on the reported event is unavailable at this time.

Manufacturer Narrative

(b)(4).Concomitant medical products: unknown-m2a magnum modular head 46mm-unknown.Multiple mdr reports were filed for this event, please see associated reports: 0001825034-2022-01300.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.

Manufacturer Narrative

This follow-up report is being submitted to relay additional information.The following sections were updated/corrected updated: b1; g3; h2; h3; h6 h6 component code: mechanical (g04) - stem reported event confirmed via medical records reviewed by a health care professional.No product was returned or pictures provided; visual and dimensional evaluations could not be performed.Part and lot identification are necessary for review of device history records, neither were 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 additional information on the reported event.

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.

Event Description

It was reported that there was an attempt to revise the head approximately 14 years post implantation due to elevated metal ion levels and prominent metallosis.The revision did not proceed as they were unable to remove the femoral head from the trunnion due to presumed cold welding.Surgeon felt the only way to correct patient's metal on metal issue would be a complete revision with full stem extraction.Although they had back up revision cups and screws, there was no clean revision hip stem available.They chose to close the case as is and return to the or the next day for a posterior approach revision with extended trochanteric osteotomy.Attempts have been made and additional information on the reported event is unavailable at this time.

• Brand Name: UNKNOWN MODULAR TAPER LOCKED FEMORAL POROUS COATED STEM 9X137MM
• Type of Device: PROSTHESIS, HIP
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; p.o. box 587; warsaw IN 46581
• Manufacturer (Section G): ZIMMER BIOMET, INC.; 56 e. bell drive; p.o. box 587; warsaw IN 46581
• Manufacturer Contact: jennifer rapsavage ; 56 e. bell dr.; warsaw, IN 46582 ; 5745260384
• MDR Report Key: 14547477
• MDR Text Key: 295240686
• Report Number: 0001825034-2022-01299
• Device Sequence Number: 1
• Product Code: JDH
• 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: 07/12/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/31/2022
• Is this an Adverse Event Report?: Yes
• 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
• Date Manufacturer Received: 06/30/2022
• 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
• Patient Sex: Female