MAUDE MDR 6961409

MDR report key: 6961409
Report number: 2530191-2017-00144
Event key: 0
Event type: 3
Date of event: 2017-10-09
Date received: 2017-10-19
Adverse event: 3
Product problem: 3
Patients in event: 0
Reporter occupation: 403
Health professional: 3
Initial report to FDA: 3
Event location: 3

Manufacturer Contact#

Contact: MR. JOHN REYHER
Address: 200 HIDDEN VALLEY ROAD MCMURRAY PA 15317 US
Phone: 724-724-7249
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	PROFORM HIP SYSTEM	28MM COCR FEMORAL HEAD	STELKAST INC.	JDO	SC1151-28MM +3.5		4596-102901				R	N

Patients#

Sequence, Received, Treatment table
Sequence	Received	Treatment	Outcome
1	2017-10-19	0	1. R

Event Narratives#

N

Patient 1

AN EVALUATION OF THE DEVICE CANNOT BE PERFORMED AS THE DEVICE WAS NOT RETURNED.

D

Patient 1

PATIENT REVISED FOR LOOSE HIP STEM; 28MM ACETABULAR LINER REVISED WITH 32MM LINER.

Primary DI, Brand, Company table
Primary DI	Brand	Company	Product code	Published
00885556116272	PERI-LOC	Smith & Nephew, Inc.	JDO	2022-03-04
00885556720806	CONQUEST FN	Smith & Nephew, Inc.	JDO	2020-03-02
00885556696279	CONQUEST FN	Smith & Nephew, Inc.	JDO	2018-06-25
00885556704059	CONQUEST FN	Smith & Nephew, Inc.	JDO	2018-06-25
00885556704202	CONQUEST FN	Smith & Nephew, Inc.	JDO	2018-06-25
00885556704219	CONQUEST FN	Smith & Nephew, Inc.	JDO	2018-06-25
00885556704257	CONQUEST FN	Smith & Nephew, Inc.	JDO	2018-06-25
00885556704271	CONQUEST FN	Smith & Nephew, Inc.	JDO	2018-06-25
00885556704288	CONQUEST FN	Smith & Nephew, Inc.	JDO	2018-06-25
00885556704295	CONQUEST FN	Smith & Nephew, Inc.	JDO	2018-06-25
00885556704325	CONQUEST FN	Smith & Nephew, Inc.	JDO	2018-06-25
00885556704332	CONQUEST FN	Smith & Nephew, Inc.	JDO	2018-06-25
00885556704349	CONQUEST FN	Smith & Nephew, Inc.	JDO	2018-06-25
00885556704363	CONQUEST FN	Smith & Nephew, Inc.	JDO	2018-06-25
00885556704370	CONQUEST FN	Smith & Nephew, Inc.	JDO	2018-06-25
00885556704387	CONQUEST FN	Smith & Nephew, Inc.	JDO	2018-06-25
00885556704417	CONQUEST FN	Smith & Nephew, Inc.	JDO	2018-06-25
00885556704448	CONQUEST FN	Smith & Nephew, Inc.	JDO	2018-06-25
00885556696262	CONQUEST FN	Smith & Nephew, Inc.	JDO	2018-01-03
00885556683613	CONQUEST FN	Smith & Nephew, Inc.	JDO	2017-06-27
00885556683620	CONQUEST FN	Smith & Nephew, Inc.	JDO	2017-06-27
00885556530207	CONQUEST FN	Smith & Nephew, Inc.	JDO	2016-03-30
00885556530238	CONQUEST FN	Smith & Nephew, Inc.	JDO	2016-03-30
00885556530245	CONQUEST FN	Smith & Nephew, Inc.	JDO	2016-03-30
00885556530269	CONQUEST FN	Smith & Nephew, Inc.	JDO	2016-03-30
00885556530283	CONQUEST FN	Smith & Nephew, Inc.	JDO	2016-03-30
00885556530306	CONQUEST FN	Smith & Nephew, Inc.	JDO	2016-03-30
00885556530313	CONQUEST FN	Smith & Nephew, Inc.	JDO	2016-03-30
00885556530320	CONQUEST FN	Smith & Nephew, Inc.	JDO	2016-03-30
00885556530351	CONQUEST FN	Smith & Nephew, Inc.	JDO	2016-03-30

Type, Submission, Product code table
Type	Submission	Product code	Device	Applicant	Decision date
510(k)	K230764	JDO	OsteoCentric Integrated Hip Fastener System	OsteoCentric Technologies	2023-04-18
510(k)	K213126	JDO	Smith & Nephew, Inc. Plates and Screws Systems: EVOS, Peri-Loc, D-Rad, TC-100, VLP Mini-Mod, Compression Hip Screw (CHS), CONQUEST FN, and cannulated screws	Smith & Nephew, Inc.	2022-09-29
510(k)	K210247	JDO	OsteoCentric Integrated Hip Fastener System	Osteocentric Technologies D.B.A. Osteocentric Trauma	2021-04-30
510(k)	K193029	JDO	CONQUEST FN	Smith & Nephew, Inc.	2020-02-28
510(k)	K173826	JDO	THP Hip Fracture Plating System	Biomet, Inc.	2018-02-07

MAUDE MDR 6961409

Related Records#

Manufacturer Contact#

Devices#

Patients#

Event Narratives#

N

D

Related GUDID Devices By Product Code#

Related PMN/PMA Records By Product Code#