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

Model Number N/A

Device Problem Insufficient Information (3190)

Patient Problem Blood Loss (2597)

Event Date 10/09/2012

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 location is unknown.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.(b)(4).Concomitant products: item # unk, stem, lot # unk; item # unk, head, lot # unk; item # unk, shell, lot # unk; item # unk, 6.5x40 x 2 (6.5x20 x 2) screw, lot # unk; item # unk, 6.5x30 (6.5x25) screw, liner, lot # unk.Multiple mdr reports were filed for this event, please see associated reports: 0001825034 - 2018 - 08064, 0001825034 - 2018 - 08065, 0001825034 - 2018 - 08066, 0001825034 - 2018 - 08068, 0001825034 - 2018 - 08069.

Event Description

It was reported that during an i&d procedure, the patient experienced blood loss of 1000 ml.Patient received transfusion of 2 units prbc's.Attempts have been made and no further information has been provided.

Manufacturer Narrative

Upon investigation it was determined that this product did not contribute to the reported event; the event is being reported on 0001825034-2018-08064, 0001825034-2018-08065, 0001825034-2018-08066.

Event Description

Upon investigation it was determined that this product did not contribute to the reported event.

• Brand Name: BIOMET UNKNOWN LINER
• Type of Device: PROSTHESIS, HIP
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• MDR Report Key: 7772481
• MDR Text Key: 116754549
• Report Number: 0001825034-2018-08067
• Device Sequence Number: 1
• Product Code: KWY
• Combination Product (y/n): N
• PMA/PMN Number: PNI
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,study
• Type of Report: Initial,Followup
• Report Date: 10/24/2018

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: 07/12/2018
• Initial Date FDA Received: 08/10/2018
• Supplement Dates Manufacturer Received: 09/24/2018
• Supplement Dates FDA Received: 10/24/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 62 YR
• Patient Weight: 161