FDA Adverse Event Malfunction Summary report: N

TRIATHLON PS FEM COMPONENT, CEMENTED

MDR report key: 1903609 · Received November 16, 2010

Report

Report Number: 2249697-2010-01554
Event Type: Malfunction
Date Received: November 16, 2010
Date of Event: January 1, 2010
Report Date: October 22, 2010
Manufacturer: STRYKER ORTHOPAEDICS MAHWAH
Product Code: JWH
PMA / PMN Number: K042993
Removal / Correction Number: NA
Product Problem: Yes
Report Source: Manufacturer report
Reporter Location: OK, US
Reporter Occupation: OTHER

Narratives

Additional Manufacturer Narrative · 1

THE FOLLOWING OTHER DEVICES WERE REPORTED TO BE IMPLANTED IN THE PT: TRIATHLON-PS TIBIAL INSERT #3 - 11MM, CAT# 5532-P-311, LOT LBP264; TRI TS BASEPLATE SIZE 3, CAT# 5521-B-300, LOT ZOGN; TRIATHLON-ASYMMETRIC PATELLA A32MM(S/I*) X 10MM, CAT# 5551-L-320, LOT LBQ350; SIMPLEX P SPEEDSET FULL DOSE 1 PACK, CAT# 6192-1-001, LOT DLQ024. IT CANNOT BE DETERMINED WHICH, IF ANY OF THESE DEVICES MAY HAVE CAUSED OR CONTRIBUTED TO THE REPORTED PT'S ISSUE. AN EVALUATION OF THE DEVICE CANNOT BE PERFORMED AS THE DEVICE REMAINED IMPLANTED IN THE PT AND WAS NOT RETURNED TO THE MANUFACTURER. ADDITIONAL INFORMATION WAS REQUESTED. THE EVALUATION SUMMARY WILL BE SUBMITTED IN A SUPPLEMENTAL REPORT.

Description of Event or Problem · 1

IT WAS REPORTED THAT, "RICK CONTACTED STRYKER VIA E-MAIL ON BEHALF OF AN ELDERLY FEMALE FRIEND WHO IS EXPERIENCING RATTLE, OR POPS WHILE WALKING OR SITTING DOWN, SHAKING THE LEG WITH NO WEIGHT ON IT. THE KNEE WAS FULLY REPLACED BACK IN (B)(6), THIS YEAR 2010. MR. (B)(6) REPORTED THAT THE PT WAS SEEN BY THE DOCTOR WHO TOLD HER THERE IS NOTHING WRONG WITH IT. HE ASKED IF THIS IS "NORMAL".

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
1	TRIATHLON PS FEM COMPONENT, CEMENTED	IMPLANT	JWH	STRYKER ORTHOPAEDICS MAHWAH	NA	XFIL

Patients

Seq	Age	Sex	Outcome	Treatment
1	71 YR		Other