FDA Adverse Event Injury Summary report: N

UHR BIPOLAR 26X54MM

MDR report key: 9726799 · Received February 19, 2020

Report

Report Number: 0002249697-2020-00345
Event Type: Injury
Date Received: February 19, 2020
Date of Event: January 22, 2020
Report Date: February 19, 2020
Manufacturer: STRYKER ORTHOPAEDICS-MAHWAH
Product Code: KWL
UDI-DI: 07613327017243
PMA / PMN Number: K800207
Adverse Event: Yes
Report Source: Manufacturer report
Reporter Location: RI, US
Reporter Occupation: PHYSICIAN

Narratives

Additional Manufacturer Narrative · 1

THE FOLLOWING DEVICES WERE ALSO LISTED IN THIS REPORT: 665918,6260-9-126,26MM STD LFIT V40 HEAD,SHC; CAT# 6260-9-126; LOT# 62051209. 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 RELEVANT REPORTED DISCREPANCIES. THERE HAVE BEEN NO OTHER SIMILAR 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 A REVISION WILL BE PERFORMED ON THE PATIENT'S HIP. AN IRRIGATION AND DEBRIDEMENT WITH REVISION OF THE BIPOLAR COMPONENT AND FEMORAL HEAD WILL BE PERFORMED ON (B)(6) 2020. THE REASON FOR THE REVISION WAS NOT REPORTED TO THE REP. REP PROVIDED THE USAGE SHEET FROM HER PREVIOUS SURGERY. THE REP MAY BE ABLE TO OBTAIN USAGE INFORMATION FOR THE UPCOMING REVISION. AS NO STRYKER REP WILL BE PRESENT FOR THE PROCEDURE, REP REPORTED THAT NO FURTHER INFORMATION WILL BE AVAILABLE.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
192766	UHR BIPOLAR 26X54MM	HIP JOINT FEMORAL (HEMI-HIP) METALLIC CEMENTED OR UNCEMENTED PROSTHESIS.	KWL	STRYKER ORTHOPAEDICS-MAHWAH	UH1-54-26	TE6JT0	07613327017243

Patients

Seq	Age	Sex	Outcome	Treatment
1	66 YR		Hospitalization\| R