MAUDE MDR 3161565

MDR report key: 3161565
Report number: 3004878714-2013-00013
Event key: 0
Event type: 3
Date received: 2013-05-06
Adverse event: 3
Product problem: 3
Patients in event: 0
Reporter occupation: 1
Health professional: 3
Initial report to FDA: 3
Event location: 0

Manufacturer Contact#

Address: HULDA MELLGRENS GATA 5 V. FROLUNDA SE-42 SW
Phone: 174-174-1746
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	ARTELON CMC SPACER	SPACER	ARTIMPLANT AB	KYI							N

Patients#

Sequence, Received, Treatment table
Sequence	Received	Treatment	Outcome
1	2013-05-06	0

Event Narratives#

D

Patient 1

EXPLANTATION OF ARTELON CMC SPACER DUE TO INCREASING PAIN AT ACTIVITY. THE PATIENT HAD BEEN PAIN FREE AND FUNCTIONAL UNTIL APPROX 18 MONTHS AFTER IMPLANT SURGERY. X-RAYS REVEALED RECURRENT OSTEOPHYTES. (SAME PATIENT AS 3004878714-2013-00014). (B)(4).

N

Patient 1

EXPLANT SENT TO HISTOLOGY. NO RESULT YET.

Primary DI, Brand, Company table
Primary DI	Brand	Company	Product code	Published
00810063560232	Ensemble CMC	Ensemble Orthopedics, Inc.	KYI	2025-05-06
M209177990	THUMB MOD HEAD TITANIUM 13MM+2	BIOPRO, INC.	KYI	2024-06-30
M209178000	THUMB MOD HEAD TITANIIUM 12MM	BIOPRO, INC.	KYI	2024-06-30
M209178010	THUMB MOD HEAD TITANIUM 12MM+2	BIOPRO, INC.	KYI	2024-06-30
M209178060	THUMB MOD HEAD TITANIUM 14MM	BIOPRO, INC.	KYI	2024-06-30
M209178070	THUMB MOD HEAD TITANIUM 14MM+2	BIOPRO, INC.	KYI	2024-06-30
M209178080	THUMB MOD HEAD TITANIUM 15MM	BIOPRO, INC.	KYI	2024-06-30
M209178090	THUMB MOD HEAD TITANIUM 15MM+2	BIOPRO, INC.	KYI	2024-06-30
M209177980	THUMB MOD HEAD TITANIUM 13MM	BIOPRO, INC.	KYI	2024-05-30
00810063560201	Ensemble CMC	Ensemble Orthopedics, Inc.	KYI	2023-08-01
00885556830789	PyroSphere CMC	Smith & Nephew, Inc.	KYI	2022-12-22
00885556830840	PyroSphere CMC	Smith & Nephew, Inc.	KYI	2022-12-22
00885556830857	PyroSphere CMC	Smith & Nephew, Inc.	KYI	2022-12-22
00885556830864	PyroSphere CMC	Smith & Nephew, Inc.	KYI	2022-12-22
00885556830871	PyroSphere CMC	Smith & Nephew, Inc.	KYI	2022-12-22
00885556830888	PyroSphere CMC	Smith & Nephew, Inc.	KYI	2022-12-22
00885556857748	NuGrip CMC	Smith & Nephew, Inc.	KYI	2022-12-22
00885556857755	NuGrip CMC	Smith & Nephew, Inc.	KYI	2022-12-22
00885556857762	NuGrip CMC	Smith & Nephew, Inc.	KYI	2022-12-22
00885556857779	NuGrip CMC	Smith & Nephew, Inc.	KYI	2022-12-22
00885556857786	NuGrip CMC	Smith & Nephew, Inc.	KYI	2022-12-22
00885556857793	NuGrip CMC	Smith & Nephew, Inc.	KYI	2022-12-22
00885556857809	NuGrip CMC	Smith & Nephew, Inc.	KYI	2022-12-22
00885556857816	NuGrip CMC	Smith & Nephew, Inc.	KYI	2022-12-22
00885556857823	NuGrip CMC	Smith & Nephew, Inc.	KYI	2022-12-22
00885556857915	NuGrip CMC	Smith & Nephew, Inc.	KYI	2022-12-22
00885556857922	NuGrip CMC	Smith & Nephew, Inc.	KYI	2022-12-22
00885556857939	NuGrip CMC	Smith & Nephew, Inc.	KYI	2022-12-22
00885556857946	NuGrip CMC	Smith & Nephew, Inc.	KYI	2022-12-22
00885556857953	NuGrip CMC	Smith & Nephew, Inc.	KYI	2022-12-22

Type, Submission, Product code table
Type	Submission	Product code	Device	Applicant	Decision date
510(k)	K201072	KYI	Ensemble CMC, Size 141, Ensemble CMC, Size 151, Ensemble CMC, Size 161	Ensemble Orthopedics, LLC	2020-12-02
510(k)	K180744	KYI	Stablyx CMC Arthroplasty Implant System	Skeletal Dynamics, LLC	2018-04-11
510(k)	K111068	KYI	STABLYX CMC ARTHROPLASTY IMPLANT MODEL SIZES 1, 2, 3, 4, AND 5	Skeletal Dynamics, LLC	2011-12-30
510(k)	K112278	KYI	ASCENSION NUGRIP CMC IMPLANT	Ascension Orthopedic	2011-11-04
510(k)	K092548	KYI	EXTREMITY MEDICAL TRAPEZIUM PROSTHESIS	Extremity Medical, LLC	2009-12-15

MAUDE MDR 3161565

Related Records#

Manufacturer Contact#

Devices#

Patients#

Event Narratives#

D

N

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