MAUDE Adverse Event Report: ZIMMER BIOMET, INC. UNKOWN SCREW; PROSTHESIS, HIP

Model Number N/A

Device Problems Unintended Movement (3026); Loosening of Implant Not Related to Bone-Ingrowth (4002); Migration (4003)

Patient Problems Pain (1994); Ambulation Difficulties (2544); Osteopenia/ Osteoporosis (2651); Limited Mobility Of The Implanted Joint (2671)

Event Date 06/10/2020

Event Type  Injury  

Manufacturer Narrative

(b)(4).No product was returned; visual and dimensional evaluations could not be performed.Medical records were provided and reviewed by a health care professional.Review of the available records identified the following: the patient underwent a revision due to failed hip arthroplasty.Office visit notes stated that patient was experiencing instability, antalgic gait.There was positive posterior and anterior impingement.Migration and increased version of the cup along with peripheral radiolucency.During the procedure, significant bone loss was identified medially.The acetabular component was grossly loose and the locking mechanism tines could not be freed up.The cup, liner, and head were revised.No other findings related to the event were noted.Part and lot identification are necessary for review of device history records, neither were provided for the screws.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.Multiple mdr reports were filed for this event, please see associated reports: 0001822565 - 2020 - 02486, 0001822565 - 2020 - 03427, 0001822565 - 2020 - 03426.

Event Description

It was reported the patient underwent left tha on an unknown date.The patient underwent a left revision approximately 15 years ago for unknown reasons.It was noted a zimmer biomet cup and liner were implanted during revision.Subsequently, the patient recently underwent another revision due to pain, instability, impingement, migration, radiolucency, loosening, and bone loss.It was noted the zimmer biomet cup and liner were removed and replaced, as well as the competitor head.The competitor stem was left in place.No further event information available at the time of this report.

• Brand Name: UNKOWN SCREW
• 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: 10620893
• MDR Text Key: 209613724
• Report Number: 0001822565-2020-03426
• Device Sequence Number: 1
• Product Code: JDI
• 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: distributor,health profession
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 10/01/2020

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: 09/30/2020
• Initial Date FDA Received: 10/02/2020
• 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: ZIMMER 7MM OFFSET LINER CAT#: 00634105832 LOT#: UNK
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Weight: 120