PALACOS LV+G RADIOPAQUE BONE CEMENT 00-1119-140-01

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2019-03-06 for PALACOS LV+G RADIOPAQUE BONE CEMENT 00-1119-140-01 manufactured by Zimmer Inc/ Zimmer Biomet.

Event Text Entries

[138257930] I slipped on some ice outside of my apartment. My foot went up and i fell down and shattered my right elbow. The doctor put screws in. They didn? T work. So, the doctor put an elbow replacement in on (b)(6) 2011, and something went wrong, so the doctor put another replacement in on (b)(6) 2012, and something was wrong with it and the doctor replaced it, and then that one went wrong on (b)(6) 2014. I got another replacement on (b)(6) 2015. All replacements on the same arm.
Patient Sequence No: 1, Text Type: D, B5

MAUDE Entry Details

Report Number	MW5084684
MDR Report Key	8396227
Date Received	2019-03-06
Date of Report	2019-02-26
Date of Event	2010-12-28
Date Added to Maude	2019-03-06
Event Key	0
Report Source Code	Voluntary report
Manufacturer Link	N
Number of Patients in Event	0
Adverse Event Flag	3
Product Problem Flag	3
Reprocessed and Reused Flag	3
Reporter Occupation	PATIENT
Health Professional	3
Initial Report to FDA	3
Report to FDA	3
Event Location	3
Single Use	3
Previous Use Code	3
Event Type	3
Type of Report	0

Device Sequence Number: 1

Brand Name	PALACOS LV+G RADIOPAQUE BONE CEMENT
Generic Name	BONE CEMENT
Product Code	LOD
Date Received	2019-03-06
Catalog Number	00-1119-140-01
Lot Number	73974284
Device Availability	*
Device Eval'ed by Mfgr	I
Device Sequence No	1
Device Event Key	0
Manufacturer	ZIMMER INC/ ZIMMER BIOMET

Device Sequence Number: 2

Brand Name	COONRAD/MORREY TOTAL ELBOW INTERCHANGEABLE ULNAR ASSEMBLY
Generic Name	PROSTHESIS ELBOW CONSTRAINED CEMENTED
Product Code	JDC
Date Received	2019-03-06
Catalog Number	32-8105-53-02
Lot Number	61971269
Device Availability	*
Device Eval'ed by Mfgr	I
Device Sequence No	2
Device Event Key	0
Manufacturer	ZIMMER INC/ ZIMMER BIOMET

Device Sequence Number: 3

Brand Name	COONRAD/MORREY TOTAL ELBOW INTERCHANGEABLE HUMERAL ASSEMBLY
Generic Name	PROSTHESIS, SHOULDER, HEMI, HUMERAL, METALLIC UNCEMENTED
Product Code	HSD
Date Received	2019-03-06
Catalog Number	32-8105-25-04
Lot Number	61940655
Device Availability	*
Device Eval'ed by Mfgr	I
Device Sequence No	3
Device Event Key	0
Manufacturer	ZIMMER INC/ ZIMMER BIOMET

Device Sequence Number: 4

Brand Name	COONRAD/MORREY TOTAL ELBOW CEMENT RESTRICTOR WITH NOZZLE
Generic Name	PROSTHESIS ELBOW SEMI CONSTRAINED CEMENTED
Product Code	JDB
Date Received	2019-03-06
Catalog Number	32-8105-38
Lot Number	62041403
Device Availability	*
Device Eval'ed by Mfgr	I
Device Sequence No	4
Device Event Key	0
Manufacturer	ZIMMER INC/ ZIMMER BIOMET

Device Sequence Number: 5

Brand Name	MILLER BONE CEMENT INJECTOR FRONT LOADING CARTRIDGE KIT
Generic Name	DISPENSER INJECTOR
Product Code	KIH
Date Received	2019-03-06
Catalog Number	5069-52
Lot Number	61234120
Device Availability	*
Device Eval'ed by Mfgr	I
Device Sequence No	5
Device Event Key	0
Manufacturer	ZIMMER BIOMET/ ZIMMER INC

Device Sequence Number: 6

Brand Name	COONRAD/MORREY TOTAL ELBOW CEMENT RESTRICTOR WITH NOZZLE
Generic Name	PROSTHESIS ELBOW SEMI CONSTRAINED CEMENTED
Product Code	JDB
Date Received	2019-03-06
Catalog Number	32-8105-38
Lot Number	61980266
Device Availability	*
Device Eval'ed by Mfgr	I
Device Sequence No	6
Device Event Key	0
Manufacturer	ZIMMER INC/ ZIMMER BIOMET

Device Sequence Number: 7

Brand Name	PALACOS LV RADIOPAQUE BONE CEMENT
Generic Name	BONE CEMENT
Product Code	LOD
Date Received	2019-03-06
Catalog Number	00-1118-140-01
Lot Number	70684239
Device Availability	*
Device Eval'ed by Mfgr	I
Device Sequence No	7
Device Event Key	0
Manufacturer	ZIMMER INC/ ZIMMER BIOMET

Patients

Patient Number	Treatment	Outcome	Date
1	0		2019-03-06