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

Model Number N/A

Device Problem Insufficient Information (3190)

Patient Problem Thrombosis (2100)

Event Date 06/06/2018

Event Type  Injury  

Manufacturer Narrative

(b)(4).Customer has indicated that the product will not be returned to zimmer biomet for investigation, as the device remains implanted.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.Additional concomitant medical products: item # unk, hip-unknown-cups-unk, lot #unk; item # unk, hip-unknown-liners-unk, lot #unk; item # unk, hip-unknown-stems-unk, lot #unk.Waterson, h.B., whitehouse, m.R., greidanus, n.V., garbuz, d.S., masri, b.A., duncan, c.P., (2018).Revision for adverse local tissue reaction following metal-on-polyethylene total hip arthroplasty is associated with a high risk of early major complications, 100-b:720¿4.(b)(6).Multiple reports have been submitted for this event.Please see associated reports: 0001822565-2018-05190, 0001822565-2018-05191, 0001822565-2018-05192, 0001822565-2018-05193.

Event Description

It was reported that post revision for armd and trunnionosis, the patient developed a femoral arterial thrombosis.This occurred following exposure to the iliofemoral due to resection of a massive pseudotumor that was located in the thigh and pelvis.The femoral thrombosis was identified in the recovery room and managed by invasive procedure, thrombectomy.Attempts have been made, and no further information has been provided.

Manufacturer Narrative

Upon receipt of additional information, it has been determined that this device did not cause or contribute to the reported event.The initial report was forwarded in error and should be voided.

Event Description

Upon receipt of additional information, it has been determined that this device did not cause or contribute to the reported event.The initial report was forwarded in error and should be voided.

• Brand Name: UNKNOWN ZIMMER FEMORAL HEAD
• Type of Device: HIP PROSTHESIS
• 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: 7901395
• MDR Text Key: 121446182
• Report Number: 0001822565-2018-05193
• Device Sequence Number: 1
• Product Code: JDG
• Combination Product (y/n): N
• Reporter Country Code: CA
• PMA/PMN Number: PNI
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,literature
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date: 10/30/2018

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?: No
• Device Operator: Health Professional
• Device Model Number: N/A
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 08/30/2018
• Initial Date FDA Received: 09/24/2018
• Supplement Dates Manufacturer Received: 10/18/2018
• Supplement Dates FDA Received: 10/30/2018
• 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
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention