FDA Adverse Event Injury Summary report: N

ARCOS CON SZ E HI 80MM HA

MDR report key: 7352559 · Received March 20, 2018

Report

Report Number: 0001825034-2018-02048
Event Type: Injury
Date Received: March 20, 2018
Date of Event: August 13, 2014
Report Date: March 20, 2018
Manufacturer: ZIMMER BIOMET, INC.
Product Code: KWA
PMA / PMN Number: PN/A
Removal / Correction Number: N/A
Adverse Event: Yes
Report Source: Manufacturer report
Reporter Location: SP
Reporter Occupation: PHYSICIAN

Narratives

Additional Manufacturer Narrative · 1

(B)(4) MULTIPLE MDR'S WERE SUBMITTED FOR THIS EVENT. PLEASE SEE REPORTS: 0001825034-2018-02049, 0001825034-2018-02050, 0001825034-2018-02051. CONCOMITANT MEDICAL PRODUCTS: 22-300920 ARCOS 20 X 190 MM SPL TPR DIST HA, LOT 530270. PT-106056 REGEN/RNGLC+ MULTI 56 MM SZ 24, LOT 187210. EP-105894 EPOLY RLC 36 MM 10DEG SZ24, LOT 251340. THE 650-0843 36 MM COCR BIOMET FEM HD +6 NK, LOT 3229357. (B)(6). REPORTED EVENT WAS UNABLE TO BE CONFIRMED DUE TO LIMITED INFORMATION RECEIVED FROM THE CUSTOMER. DHR WAS REVIEWED AND NO DISCREPANCIES WERE FOUND. 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. DEVICE REMAINS IMPLANTED.

Description of Event or Problem · 1

IT WAS REPORTED THAT THE PATIENT UNDERWENT A TOTAL LEFT HIP ARTHROPLASTY. SUBSEQUENTLY, THE PATIENT DEVELOPED A URINARY TRACT INFECTION POST-IMPLANTATION. ATTEMPTS HAVE BEEN MADE AND NO FURTHER INFORMATION HAS BEEN MADE AVAILABLE AT THIS TIME.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
199076	ARCOS CON SZ E HI 80MM HA	PROSTHESIS, HIP	KWA	ZIMMER BIOMET, INC.	N/A	766400

Patients

Seq	Age	Sex	Outcome	Treatment
1	65 YR		Other