MAUDE Adverse Event Report: ZIMMER BIOMET, INC. UNKNOWN 14MM POLY; PROSTHESIS, KNEE

Model Number N/A

Device Problem Unintended Movement (3026)

Patient Problem Ischemia (1942)

Event Date 10/24/2017

Event Type  Injury  

Manufacturer Narrative

(b)(4).Multiple mdr reports were filed for this event, please see associated report: 0001822565-2023-01841, 0002648920-2023-00148, 0001822565-2023-01842, 0001822565-2023-01843.D10-medical product size 5 precoat cemented tibial component item# 00588000500 lot# 61518663.Long 15mm diameter 155mm length straight stem extension item# 00598801115 lot# 62172241.Fluted stem extension straight precoat item# 00585205017 lot# 61867926.Femoral hinge service kit size c item# 00585007013 lot# 61929556.G2- spain.H3- 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 that a patient underwent an arterial bypass graft in the left leg to increase blood flow and prevent further occlusion complications approximately four years and three months post implantation.The patient presented to the er with changes in color and sensation in the left foot.The physician attributed the event to recreational drug-induced ischemia with rhabdomyolysis and dermal lesions leading to necrosis of the phalanges.Six weeks later, the patient returned with the same complaints.This time, the patient had an arteriogram which showed arterial compression secondary to the knee prosthesis.The patient then had an arterial bypass graft in the left leg to increase blood flow and prevent further occlusion complications.

Event Description

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

Manufacturer Narrative

This follow-up is being submitted to relay additional information.No product was returned, or pictures provided; therefore, visual and dimensional evaluations could not be performed.Medical records/radiographs were provided and reviewed by a health care professional.Review of the available records identified the following: no complication during the primary surgery.Five months after the surgery, patient was admitted to the er for change in color and sensation.Patient underwent bypass graft due to arterial compression secondary to the knee prosthesis.Device history record (dhr) review was unable to be performed as the part and lot number of the device involved in the event is unknown.A definitive root cause cannot be determined.Complaint is confirmed based on the medical record review.If any further information is received which would change or alter any conclusions or information, a supplemental will be filed accordingly.Zimmer biomet will continue to monitor for trends.

• Brand Name: UNKNOWN 14MM POLY
• Type of Device: PROSTHESIS, KNEE
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 1800 w. center st.; warsaw IN 46580
• Manufacturer (Section G): ZIMMER BIOMET, INC.; 1800 w. center st.; warsaw IN 46580
• Manufacturer Contact: jennifer rapsavage ; 56 e. bell dr.; warsaw, IN 46582 ; 5745260384
• MDR Report Key: 17278229
• MDR Text Key: 318574348
• Report Number: 0001822565-2023-01844
• Device Sequence Number: 1
• Product Code: JWH
• Combination Product (y/n): N
• Reporter Country Code: SP
• PMA/PMN Number: N/A
• 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
• Report Date: 11/16/2023

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: 06/27/2023
• Initial Date FDA Received: 07/07/2023
• Supplement Dates Manufacturer Received: 11/14/2023
• Supplement Dates FDA Received: 11/16/2023
• 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): Required Intervention; Hospitalization
• Patient Age: 25 YR
• Patient Sex: Male
• Patient Weight: 100 KG
• Patient Ethnicity: Hispanic