MAUDE Adverse Event Report: ZIMMER BIOMET, INC. OSTEOBOND DOUGH-TYPE RADIOPAQUE BONE CEMENT

Model Number N/A

Device Problem Insufficient Information (3190)

Patient Problems Unspecified Infection (1930); Pain (1994)

Event Type  Injury  

Manufacturer Narrative

(b)(4).Concomitant medical products: item # 00585001302, lot # unk, zimmer distal femoral component, item # 00585003020, lot # unk, zimmer segmental articular surface, item # 00588000600, lot # unk, nexgen rotating hinge precoat tibial plate, item # 00585001395, lot # unk, zimmer segmental polyethylene insert, item # 00598801515, lot # unk, nexgen stem extension sharp fluted, item # 00585205013, lot # unk, zimmer segmental fluted stem extension, item # 00585007013, lot # unk, zimmer segmental femoral hinge service kit , item # 00585004603, lot # unk, zimmer segmental segment with male/female taper, item # 00597206532, lot # unk, nexgen all poly patella, item # 00585204030, lot # unk collar tm seg 9-16mm 30mm.The product will not be returned to zimmer biomet for investigation, as it remains implanted.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.This bone cement is manufactured at heraeus medical and distributed through zimmer orthopedic surgical products.Multiple mdr reports were filled for this event: 0001822565-2017-06561, 0001822565-2017-06560, 0001822565-2017-06547, 0001822565-2017-06562, 0001822565-2017-06564, 0001822565-2018-05791, 0001822565-2018-05792, 0001822565-2018-05794, 0002648920-2018-00755.Remains implanted.

Event Description

It was reported that after a knee arthroplasty revision that the patient developed a bladder infection due to his immobility and possible nostril catheter used during a recovery.After the knee revision the patient was in extreme pain and went to an emergency room for treatment.His leg was immobilized for another two weeks after the revision and he developed the bladder infection.

Event Description

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

Manufacturer Narrative

Reported event was confirmed by review of operative notes provided.Device was not returned.Device history record (dhr) review was unable to be performed as the lot number of the device involved in the event is unknown.Root cause was unable to be determined as the necessary information to adequately investigate the reported event was not provided.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.

• Brand Name: OSTEOBOND DOUGH-TYPE RADIOPAQUE BONE CEMENT
• Type of Device: BONE CEMENT
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• MDR Report Key: 7980430
• MDR Text Key: 124183341
• Report Number: 0001822565-2018-05795
• Device Sequence Number: 1
• Product Code: LOD
• Combination Product (y/n): N
• PMA/PMN Number: PK030902
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup
• Report Date: 08/13/2019

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
• Device Catalogue Number: 00111214001
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 09/21/2018
• Initial Date FDA Received: 10/18/2018
• Supplement Dates Manufacturer Received: 07/29/2019
• Supplement Dates FDA Received: 08/13/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention