FDA Adverse Event Injury Summary report: N

UNKNOWN KNEE

MDR report key: 6967366 · Received October 21, 2017

Report

Report Number: 0001825034-2017-09319
Event Type: Injury
Date Received: October 21, 2017
Report Date: October 19, 2017
Manufacturer: ZIMMER BIOMET, INC.
Product Code: HRY
PMA / PMN Number: PN/A
Removal / Correction Number: N/A
Adverse Event: Yes
Report Source: Manufacturer report
Reporter Location: AS
Reporter Occupation: OTHER

Narratives

Additional Manufacturer Narrative · 1

ZIMMER BIOMET COMPLAINT- (B)(4). REPORTED EVENT WAS UNABLE TO BE CONFIRMED AS PART NUMBER AND LOT NUMBER OF THE DEVICE INVOLVED IN THE INCIDENT IS UNKNOWN. DEVICE HISTORY RECORD REVIEW WAS UNABLE TO BE PERFORMED AS THE LOT NUMBER OF THE DEVICE INVOLVED IN THE EVENT IS UNKNOWN. ROOT CAUSE WAS UNABLE TO BE DETERMINED AS THE NECESSARY INFORMATION TO ADEQUATELY INVESTIGATE THE REPORTED EVENT WAS NOT PROVIDED. IF ANY FURTHER INFORMATION IS FOUND WHICH WOULD CHANGE OR ALTER ANY CONCLUSIONS OR INFORMATION, A SUPPLEMENTAL WILL BE FILED ACCORDINGLY. ZIMMER BIOMET WILL CONTINUE TO MONITOR FOR TRENDS. THIS REPORT IS BEING SUBMITTED LATE AS IT HAS BEEN IDENTIFIED IN REMEDIATION. O¿DONNELL, T., & NEIL, M. J. (2010). THE REPICCI II UNICONDYLAR KNEE ARTHROPLASTY 9-YEAR SURVIVORSHIP AND FUNCTION. CLINICAL ORTHOPAEDICS AND RELATED RESEARCH, 468(NO. 11), 3094-3102. DOI:10.1007/S11999-010-1474-6.

Description of Event or Problem · 1

INFORMATION WAS RECEIVED BASED ON REVIEW OF A JOURNAL ARTICLE ENTITLED, "THE REPICCI II UNICONDYLAR KNEE ARTHROPLASTY 9-YEAR SURVIVORSHIP AND FUNCTION." ONE PATIENT WAS IDENTIFIED IN THE ARTICLE WHO DEVELOPED A HEMARTHROSIS FIVE (5) DAYS POST OPERATIVELY. THERE HAS BEEN NO FURTHER INFORMATION PROVIDED AND THE PATIENT OUTCOME IS UNKNOWN.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
746799	UNKNOWN KNEE	KNEE PROSTHESIS	HRY	ZIMMER BIOMET, INC.	NI	NI

Patients

Seq	Age	Sex	Outcome	Treatment
1			Other