MAUDE Adverse Event Report: ZIMMER BIOMET, INC. PLUG APICAL EXT TAPER; PROSTHESIS, HIP

Model Number N/A

Device Problem Patient Device Interaction Problem (4001)

Patient Problems Bacterial Infection (1735); Failure of Implant (1924); Muscle Weakness (1967); Necrosis (1971); Pain (1994); Loss of Range of Motion (2032); Scar Tissue (2060); Synovitis (2094); Osteolysis (2377); Ambulation Difficulties (2544); Osteopenia/ Osteoporosis (2651); Metal Related Pathology (4530)

Event Date 11/13/2019

Event Type  Injury  

Manufacturer Narrative

(b)(4).Concomitant medical devices: 13-104056 lot 286210 biomet mallory head shell, 15-103209 lot 804070 biomet taperloc microplasty femoral , s031140 lot 212850 biomet select magnum modular head, xl-108424 lot 723310 arcomxl ringloc acetabular liner.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.Multiple mdr reports were filed for this event, please see associated reports: 0001825034 - 2022 - 02232, 0001825034 - 2022 - 02233, 0001825034 - 2022 - 02234, 0001825034 - 2022 - 02235.

Event Description

It was reported the patient underwent a initial left total hip arthroplasty.Subsequently, the patient experienced increasing pain and difficulty in the hip.Follow-up labs revealed elevated metal ion levels, and mri showed an extensive pseudocapsule.During the revision, the pseudotumor was not able to be fully excised due to its size.In addition, metallosis, trunnionosis, adverse local tissue reaction, and poly wear were noted.The cultures taken during procedure were positive for staphylococcus hominis and the patient has been treated with antibiotics for this.All components were replaced without difficulty.It was reported the patient continues to experience sequelae from the initial implants.No additional information.

Manufacturer Narrative

This follow-up report is being submitted to relay additional information.Reported event was confirmed due to the review of medical records.Medical records were provided and reviewed by a health care professional.Review of the available records identified the following: xray showed bone demineralization with lucency adjacent to the tip of the femoral and acetabular components.Large joint effusion with extensive synovitis which extended through the anterior pseudocapsule/pseudotumor.Findings were most consistent with metallosis and presumed altr secondary to metal hypersensitivity.There was no gross evidence of infection, bone quality was somewhat osteopenic.When the femoral head was removed carbonaceous deposits consistent with the diagnosis of metallosis/trunnionosis were noted.The acetabular liner had to be removed in a piecemeal fashion due to its thin and brittle nature of the remaining polyethylene.Device history record (dhr) review was unable to be performed as the lot number of the device involved in the event is unknown.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 further event information available at the time of this report.

• Brand Name: PLUG APICAL EXT TAPER
• 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: 15504081
• MDR Text Key: 300793880
• Report Number: 0001825034-2022-02236
• 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: Other,Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 10/28/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/29/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: 1353C0
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 10/12/2022
• 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: N/A
• Patient Sequence Number: 1
• Treatment: SEE H10 NARRATIVE
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Sex: Male