MAUDE Adverse Event Report: ZIMMER BIOMET, INC. REVISION SHELL LINER CEMENTED LINER FACE ANGLE OBLIQUE; PROSTHESIS, HIP

Model Number N/A

Device Problems Material Erosion (1214); Unstable (1667); Device Dislodged or Dislocated (2923)

Patient Problems Pain (1994); Joint Dislocation (2374); Reaction (2414)

Event Date 11/19/2018

Event Type  Injury  

Manufacturer Narrative

(b)(4).Customer has indicated that the product will not be returned to zimmer biomet for investigation.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.

Event Description

It was reported by patients¿ legal counsel that the patient underwent a left hip revision procedure approximately two years post-implantation to metallosis and elevated metal ions.Attempts have been made and no further information has been provided.

Manufacturer Narrative

This follow-up report is being submitted to relay additional information.The following sections were updated/corrected updated: b4, b5, g3, h2, h3, h6 reported event was confirmed by review of medical records.Medical records for the first revision were provided and reviewed by a healthcare professional.The patient underwent a revision due to failure of the ceramic liner.The head was eccentricity of the head was noted causing grinding and squeaking.Both the stem and cup were well fixed and in appropriate version.Given the osteolysis around the cup and the patient¿s age (80), it was decided not to remove the cup and instead elected to cement the liner as the surgeon was unable to use a non-cemented liner with the damaged cup from the ceramic failure.No intraoperative complications were noted.The patient underwent a second revision due to metal ion levels and metallosis.Operative notes were not provided for this revision.Off label use between the head and liner was identified and may have contributed to the reported event; however, a definitive root cause could not be determined.Device history record (dhr) was reviewed and no discrepancies were found.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.

Event Description

It was reported the patient underwent a left hip revision approximately 2 years post implantation due to elevated metal ion levels, metallosis, pain and a dislocation.No additional information.

Manufacturer Narrative

Reported event was confirmed due to the review of medical records.Medical records/radiographs were provided and reviewed by a health care professional.A review of the available records identified findings of the reported issues metallosis caused by the competitor head and/or zimmer implants, lab results showing increased ion levels, pain and dislocations, instability as noted.Black fluid staining, head deformed and worn, no corrosion shell and stem well fixed.Device history record (dhr) was reviewed and no discrepancies were found.Off label use between the head and liner was identified and may have contributed to the reported event; however, a definitive root cause could not be determined.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

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

• Brand Name: REVISION SHELL LINER CEMENTED LINER FACE ANGLE OBLIQUE
• 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: 10957935
• MDR Text Key: 219868871
• Report Number: 0001822565-2020-03944
• Device Sequence Number: 1
• Product Code: JDI
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K051516
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Consumer,Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 11/29/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 12/31/2019
• Device Model Number: N/A
• Device Catalogue Number: 00711004828
• Device Lot Number: 62895935
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 11/11/2020
• Initial Date FDA Received: 12/07/2020
• Supplement Dates Manufacturer Received: 04/15/2021; 06/28/2021; 11/29/2021
• Supplement Dates FDA Received: 04/19/2021; 07/15/2021; 12/02/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/22/2014
• 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
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Sex: Male
• Patient Weight: 87 KG