MAUDE Adverse Event Report: ZIMMER BIOMET, INC. UNKNOWN CUP; PROSTHESIS, HIP

Model Number N/A

Device Problem Corroded (1131)

Patient Problems Erosion (1750); Cyst(s) (1800); Necrosis (1971); Pain (1994); Scar Tissue (2060); Synovitis (2094); Osteolysis (2377); Metal Related Pathology (4530)

Event Date 02/20/2019

Event Type  Injury  

Manufacturer Narrative

(b)(4).Concomitant medical devices: unknown m/l taper stem; unknown longevity acetabular liner; femoral head cat# 00-8018-036-02 lot# 60774028; unknown kinectiv neck.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 through patient's medical records that the patient underwent a right hip revision approximately 11 years post implantation due to elevated metal ion levels, synovitis, pain, pseudotumor, metallosis, bone erosion, instability, cyst, necrosis, scar tissue, in-vivo corrosion, and osteolysis.

Manufacturer Narrative

This follow-up report is being submitted to relay additional information.Reported event was confirmed by review of medical records.Medical records were provided and reviewed by a health care professional.Review of the available records identified the following: the patient underwent an initial right hip arthroplasty on (b)(6)2008 due to degenerative arthritis.The patient was revised on (b)(6) 2019 due to failed hip arthroplasty.Blood work: on (b)(6) 2017 ¿ chromium <0.5 mcg/l, cobalt 2.9 mcg/l h range <=1.8 mcg/l.On (b)(6) 2018 ¿ chromium 0.5 mcg/l, cobalt 5.8 mcg/l h range <=1.8 mcg/l.The patient had pain and persistent instability of the hip.Mri revealed massive pseudotumor throughout the hindquarter and proximal femur.The hip capsule was pierced decompressing a massive fluid-particulate effusion and cyst, which seemed to deflate the prominent bulging cyst over the greater trochanter.A massive pseudotumor was debrided from the joint.The entire greater trochanter was "bald".There were no soft tissue attachments of the abductors or short external rotators to the greater trochanter.Significant corrosion was observed in the head's taper.There were various circular erosion patterns of the trunnion of the neck but no gouges or deformity.Significant amount of osteolysis of the acetabulum involving the entire posterior column and the wall exposing the posterior half of the metal shell.The shell and stem were well fixed.The head, liner, and locking ring were replaced with new zimmer biomet products.No other findings/complications related to the reported event were noted.Device history record (dhr) review was unable to be performed as the lot number of the device involved in the event is unknown.Root cause was unable to be determined as the necessary information to adequately investigate the reported event was not provided.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: UNKNOWN CUP
• Type of Device: PROSTHESIS, HIP
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• MDR Report Key: 11406414
• MDR Text Key: 240613196
• Report Number: 0001822565-2021-00467
• Device Sequence Number: 1
• Product Code: JDI
• Combination Product (y/n): N
• PMA/PMN Number: NI
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,health professional
• Type of Report: Initial,Followup
• Report Date: 05/13/2021

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 Model Number: N/A
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 02/10/2021
• Initial Date FDA Received: 03/03/2021
• Supplement Dates Manufacturer Received: 05/12/2021
• Supplement Dates FDA Received: 05/13/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Treatment: SEE H10 NARRATIVE.
• Patient Outcome(s): Hospitalization; Required Intervention