MAUDE Adverse Event Report: ZIMMER BIOMET, INC. UNK ZIMMER 14MM STANDARD VERSYS FIBER METAL TAPER HA COATED STEM; PROSTHESIS, HIP

Model Number N/A

Device Problem Material Erosion (1214)

Patient Problems Pain (1994); Synovitis (2094); Ambulation Difficulties (2544); Metal Related Pathology (4530)

Event Date 11/23/2022

Event Type  Injury  

Manufacturer Narrative

(b)(4).Unk zimmer 52mm durom lvh metal-on-metal non ha coated cup, unk zimmer metal acetabular liner, unk zimmer 0, 46mm cobalt chrome femoral head.The 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.

Event Description

It was reported that the patient underwent revision approximately 15 years after initial surgery due to elevated metal ion levels, limited activities of daily living and pain.During surgery it was noted that the patient had some brown staining of the synovium and there was no muscle damage noted.The metal standard 46 mm head was removed, the durom shell was inspected showing no blemishes, and it was well fixed and well positioned.A new +3.5 ceramic head and sleeve was placed into the table with the 46 mm polyethylene head with the special assembly.This was then inserted and impacted onto the cleaned femoral trunnion.The head was reduced and was stable.It was reported that no further information is available.

Event Description

No further information at the time of this report.

Manufacturer Narrative

This follow-up report is being submitted to relay additional information.Mechanical (g04) - stem.No product was returned; visual and dimensional evaluations could not be performed.Part and lot identification are necessary for review of device history records, neither were provided.Medical records/radiographs were provided and reviewed by a health care professional.A review of the available records identified findings of the reported issues.Labs ordered found significant elevation of cobalt and chromium.A one-time car accident was mentioned with unknown date.Fluid collection of 6.3cm on right, x-ray shows components in good position.Issues affecting quality of life.During revision, brown staining throughout hip, black staining on trunnion but no other defects.Moderate synovitis, good rom and stability.No intraoperative complications.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.

• Brand Name: UNK ZIMMER 14MM STANDARD VERSYS FIBER METAL TAPER HA COATED STEM
• Type of Device: PROSTHESIS, HIP
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 1800 w. center st.; warsaw IN 46580
• Manufacturer (Section G): ZIMMER BIOMET, INC.; 1800 w. center st.; warsaw IN 46580
• Manufacturer Contact: jennifer rapsavage ; 56 e. bell dr.; warsaw, IN 46582 ; 5745260384
• MDR Report Key: 16335172
• MDR Text Key: 309186878
• Report Number: 0001822565-2023-00243
• Device Sequence Number: 1
• Product Code: JDI
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: N/A
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Consumer,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 03/21/2023

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 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: 01/17/2023
• Initial Date FDA Received: 02/09/2023
• Supplement Dates Manufacturer Received: 03/20/2023
• Supplement Dates FDA Received: 03/22/2023
• 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 Sequence Number: 1
• Patient Outcome(s): Required Intervention; Hospitalization
• Patient Age: 65 YR
• Patient Sex: Female