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

Model Number N/A

Device Problem Corroded (1131)

Patient Problems Necrosis (1971); Pain (1994); Loss of Range of Motion (2032); Osteolysis (2377); Metal Related Pathology (4530); Muscle/Tendon Damage (4532); Swelling/ Edema (4577)

Event Date 06/04/2020

Event Type  Injury  

Manufacturer Narrative

(b)(4).Customer has indicated that the product will not be returned to zimmer biomet for the investigation as the product remains implanted.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.Multiple mdr reports were filed for this event, please see associated reports: 0001825034 - 2021 - 01716, 0001825034 - 2021 - 01717.

Event Description

It was reported that patient underwent a right hip revision approximately 16 years post implantation due to pain and metallosis related pathology.Pseudotumor was found on mri along with significant osteolysis around the cup.Trunnionosis and black corrosion were found on the head taper and stem.Attempts have been made and additional information on the reported event is unavailable at this time.

Manufacturer Narrative

(b)(4).This follow-up report is being submitted to relay additional information.Reported event was confirmed by review of medial records.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.Medical records identified the following: metallosis/trunnionosis and pseudotumor formation.Patient presented with hip pain, swelling, and abductor dysfunction, infection workup negative with normal esr and crp.Pseudotumor diagnosed on mri, ct showed significant osteolysis around the cup but no obvious loosening.Pseudotumor was excised and all necrotic tissue was removed.Noted was near complete destruction of the gluteus medius and minimus with no attachment on the greater trochanter.Head removed from the stem without difficulty, trunnionosis with black corrosion on the femoral head taper as well as the stem, stem well fixed.Significant osteolysis along the superior and lateral acetabulum, no evidence of loosening.Cup left in place with bone graft packing.If any further information is found which would change or alter any conclusions or information, a supplemental report 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 STEM
• Type of Device: PROSTHESIS, HIP
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• MDR Report Key: 11940979
• MDR Text Key: 254469588
• Report Number: 0001825034-2021-01718
• Device Sequence Number: 1
• Product Code: KWA
• 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: 08/02/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/04/2021
• 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
• Date Manufacturer Received: 07/30/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Treatment: UNKNOWN CUP.; UNKNOWN HEAD.
• Patient Outcome(s): Hospitalization; Required Intervention