FDA Adverse Event Injury Summary report: N

TRIDENT 0 DEG INSERT 40MM

MDR report key: 6821311 · Received August 25, 2017

Report

Report Number: 0002249697-2017-02614
Event Type: Injury
Date Received: August 25, 2017
Date of Event: July 31, 2017
Report Date: August 25, 2017
Manufacturer: STRYKER ORTHOPAEDICS-MAHWAH
Product Code: LPH
PMA / PMN Number: K061434
Adverse Event: Yes
Report Source: Manufacturer report
Reporter Location: FL, US
Reporter Occupation: PHYSICIAN

Narratives

Additional Manufacturer Narrative · 1

THE FOLLOWING DEVICES WERE ALSO LISTED IN THIS REPORT: PRIMARY TRITANIUM HEMI SOLIDBACK CUP 62MM; CAT# 500-03-62G; LOT# MMEL0E REAMER SHAFT, MOD.TRINKLE BIXCUT Ø8.0X284 MM; CAT# 02278240S; LOT# K02A1E5 GUIDE WIRE, SMOOTH-TIPPED, STERILE T2 HUMERUS Ø2,2X800 MM; CAT# 18060093S; LOT# K020C27 DELTA UN.FEM HD 40MM R40 16/18; CAT# 6519-1-040; LOT# 41177805 UNI ADAPTOR SLEEVE V40 TI; CAT# 6519-T-204; LOT# 41818101 CITATION TMZF HA SHORT SIZE#6R; CAT# 6265-5216; LOT# 43391801 IT CANNOT BE DETERMINED WHICH, IF ANY OF THESE DEVICES MAY HAVE CAUSED OR CONTRIBUTED TO THE PATIENT'S EXPERIENCE. REVIEW OF THE DEVICE HISTORY RECORDS INDICATE DEVICES WERE MANUFACTURED AND ACCEPTED INTO FINAL STOCK WITH NO REPORTED DISCREPANCIES. THERE HAVE BEEN NO OTHER EVENTS FOR THE LOT REFERENCED. IT WAS NOTED THAT THE DEVICE IS NOT AVAILABLE FOR EVALUATION. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE, IT WILL BE PROVIDED IN A SUPPLEMENTAL REPORT UPON COMPLETION OF THE INVESTIGATION.

Description of Event or Problem · 1

IT WAS REPORTED THAT THE SURGEON REVISED A PATIENT'S RIGHT HIP DUE TO PAIN. EVERYTHING EXCEPT THE STEM WAS REVISED.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
602439	TRIDENT 0 DEG INSERT 40MM	PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED	LPH	STRYKER ORTHOPAEDICS-MAHWAH		MHHNXT

Patients

Seq	Age	Sex	Outcome	Treatment
1	65 YR		Hospitalization\| R