MAUDE Adverse Event Report: ZIMMER BIOMET, INC. EXPLOR IMPLANT LOCKING SCREW; PROSTHESIS IMPLANT

Model Number N/A

Device Problems Migration or Expulsion of Device (1395); Physical Resistance/Sticking (4012)

Patient Problems Bacterial Infection (1735); Failure of Implant (1924); Loss of Range of Motion (2032)

Event Date 01/22/2020

Event Type  Injury  

Manufacturer Narrative

(b)(4).Report source foreign: (b)(6).Customer has indicated that the product will not be returned to zimmer biomet for investigation, as its location is unknown.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.Device will not be returned.

Event Description

It was reported through legal that an initial right radial head replacement with lateral ligament reconstruction performed approximately 5 years ago.Subsequently, the patient underwent stage 1 revision with placement of antibiotic beads about 2 years ago due to infection.Post-revision x-rays demonstrated destructive changes with asymmetry in the humeroulnar joint with volar shift of the distal humerus, but the patient healed well with antibiotic treatment.About 5 months later, the patient underwent stage 2 revision with reimplantation of an unknown total elbow arthroplasty.Displacement of the locking screw was noted.

Event Description

It was reported that a patient underwent a revision procedure approximately 30 months post implantation due to infection and migration of the radial head and locking screw.No further event information is available at the time of this event.

Manufacturer Narrative

This follow-up report is being submitted to relay additional information.D10: explor 9x30mm impl stem w/scr cat# 11-210064 lot#ni.Explor 14x24 mm implant head cat# 11-210043 lot#ni.No products were returned or pictures provided; visual and dimensional evaluations could not be performed.Lot identification is necessary for review of device history records; lot identification was not provided.Medical records were not provided.Legal records were provided and reviewed by a health care professional.Review of the available records identified the following: -primary surgery: initial right radial head replacement with lateral ligament reconstruction performed.-1 week follow up: no complications on the x-ray.-10 week follow up: no issues noted.-30 month followup : concerns with elbow, aspiration performed, negative for growth.X-rays indicate proximal migration of the radial head with displacement of the locking screw, concern for septic arthritis.-subsequently, the patient underwent stage 1 revision with placement of antibiotic beads due to infection.Post-revision x-rays demonstrated destructive changes with asymmetry in the humeroulnar joint with volar shift of the distal humerus, but the patient healed well with antibiotic treatment.-2 month post revision: x-ray showed destructive changes in the humeroulnar joint with volar shift of the distal humerus, healing well.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: 0001825034 - 2022 - 01230, 0001825034 - 2022 - 01231.

Event Description

No further event information is available at the time of this report.

Manufacturer Narrative

This follow-up report is being submitted to relay additional information.The following sections were corrected: d4 (lot #).

• Brand Name: EXPLOR IMPLANT LOCKING SCREW
• Type of Device: PROSTHESIS IMPLANT
• 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: 13559858
• MDR Text Key: 286767073
• Report Number: 0001825034-2022-00368
• Device Sequence Number: 1
• Product Code: KWI
• Combination Product (y/n): N
• Reporter Country Code: CA
• PMA/PMN Number: K051385
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 05/17/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/18/2022
• 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: 11-210099
• Device Lot Number: 418098
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 05/11/2022
• 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
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Sex: Female