MAUDE MDR 9261938

MDR report key: 9261938
Report number: 1818910-2019-113427
Event key: 0
Event type: 3
Date of event: 2019-10-07
Date received: 2019-10-31
Adverse event: 3
Product problem: 3
Patients in event: 0
Reporter occupation: 100
Health professional: 3
Initial report to FDA: 3
Event location: 3

Manufacturer Contact#

Contact: KARA DITTY-BOVARD
Address: 1210 WARD AVENUE WEST CHESTER PA 46581 US
Phone: 610-610-6107
Report source: M
Manufacturer link flag: Y

Devices#

Seq, Brand, Generic table
Seq	Brand	Generic	Manufacturer	Product code	Model	Catalog	Lot	PMA	510(k)	Implant	Evaluated	Availability
1	MODULAR CATHCART BALL 52MM OD	HEMI HIP IMPLANT : HIP ACETABULAR METAL HEMI	DEPUY ORTHOPAEDICS INC US	LZY		136352000	J03G16				R	N

Patients#

Sequence, Received, Treatment table
Sequence	Received	Treatment	Outcome
1	2019-10-31	0	1. R

Event Narratives#

No narrative records found.

Primary DI, Brand, Company table
Primary DI	Brand	Company	Product code	Published
07630030804342	AMIStem-H Proximal Coating	Medacta International SA	LZY	2021-10-22
07630030804359	AMIStem-H Proximal Coating	Medacta International SA	LZY	2021-10-22
07630030804458	AMIStem-H Proximal Coating	Medacta International SA	LZY	2021-10-22
07630040719988	AMIStem-P	Medacta International SA	LZY	2021-10-22
07630040719995	AMIStem-P	Medacta International SA	LZY	2021-10-22
07630040720007	AMIStem-P	Medacta International SA	LZY	2021-10-22
07630040720014	AMIStem-P	Medacta International SA	LZY	2021-10-22
07630040720021	AMIStem-P	Medacta International SA	LZY	2021-10-22
07630040720038	AMIStem-P	Medacta International SA	LZY	2021-10-22
07630040720045	AMIStem-P	Medacta International SA	LZY	2021-10-22
07630040720052	AMIStem-P	Medacta International SA	LZY	2021-10-22
07630040720069	AMIStem-P	Medacta International SA	LZY	2021-10-22
07630040720076	AMIStem-P	Medacta International SA	LZY	2021-10-22
07630040720083	AMIStem-P	Medacta International SA	LZY	2021-10-22
07630040720090	AMIStem-P	Medacta International SA	LZY	2021-10-22
07630040720106	AMIStem-P	Medacta International SA	LZY	2021-10-22
07630040720113	AMIStem-P	Medacta International SA	LZY	2021-10-22
07630040720120	AMIStem-P	Medacta International SA	LZY	2021-10-22
07630040720137	AMIStem-P	Medacta International SA	LZY	2021-10-22
07630040720144	AMIStem-P	Medacta International SA	LZY	2021-10-22
07630040720151	AMIStem-P	Medacta International SA	LZY	2021-10-22
07630040720168	AMIStem-P	Medacta International SA	LZY	2021-10-22
07630040720175	AMIStem-P	Medacta International SA	LZY	2021-10-22
07630040720182	AMIStem-P Collared	Medacta International SA	LZY	2021-10-22
07630040720199	AMIStem-P Collared	Medacta International SA	LZY	2021-10-22
07630040720205	AMIStem-P Collared	Medacta International SA	LZY	2021-10-22
07630040720212	AMIStem-P Collared	Medacta International SA	LZY	2021-10-22
07630040720229	AMIStem-P Collared	Medacta International SA	LZY	2021-10-22
07630040720236	AMIStem-P Collared	Medacta International SA	LZY	2021-10-22
07630040720243	AMIStem-P Collared	Medacta International SA	LZY	2021-10-22

Type, Submission, Product code table
Type	Submission	Product code	Device	Applicant	Decision date
510(k)	K231448	LZY	TANDEM Hip System	Smith & Nephew, Inc.	2023-07-19
510(k)	K111145	LZY	ENDO HEAD	Medacta International	2011-08-16
510(k)	K974442	LZY	PRE-POWDERED NITRILE EXAMINATION GLOVES	P.T. Latexindo Tobaperkasa	1998-01-05
510(k)	K915528	LZY	BHR BIPOLAR FEMORAL HEAD COMPONENT	Implantology Corp.	1993-06-29
510(k)	K915548	LZY	IONGUARD TITANIUM MODULAR HEADS	Biomet, Inc.	1992-03-10

MAUDE MDR 9261938

Related Records#

Manufacturer Contact#

Devices#

Patients#

Event Narratives#

Related GUDID Devices By Product Code#

Related PMN/PMA Records By Product Code#