FDA Adverse Event Injury Summary report: N

36MM COCR BIOMET FEM HD +6 NK

MDR report key: 7855463 · Received September 7, 2018

Report

Report Number: 3002806535-2018-01059
Event Type: Injury
Date Received: September 7, 2018
Date of Event: August 13, 2014
Report Date: September 7, 2018
Manufacturer: BIOMET UK LTD.
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). (B)(6). THIS PRODUCT IS MANUFACTURED BY ZIMMER BIOMET US AND IS NOT CLEARED OR DISTRIBUTED IN THE U.S. HOWEVER, THIS REPORT IS BEING SUBMITTED AS ZIMMER BIOMET IN (B)(4) MANUFACTURES A SIMILAR DEVICE IN THE UNITED STATES UNDER 510K NUMBER K042037. CONCOMITANT PRODUCTS: 22-300920 ARCOS 20X190MM SPL TPR DIST HA 530270; PT-106056 REGEN/RNGLC+ MULTI 56MM SZ 24 187210; EP-105894 EPOLY RLC 36MM 10DEG SZ24 251340; 22-301355 ARCOS CON SZ E HI 80MM HA 766400; 103531 TI LOW PROFILE SCREW 6.5X20MM 3364867; 103534 BM ACET LP DOME SCW TI S/TAP DIA6.5X35MM 3094517. THE COMPLAINT CANNOT BE CONFIRMED AS THE FOLLOW OP NOTES WERE NOT PROVIDED. REVIEW OF THE DEVICE HISTORY RECORD IDENTIFIED NO DEVIATIONS OR ANOMALIES. ROOT CAUSE COULD NOT BE DETERMINED WITH INFORMATION AVAILABLE. 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.

Description of Event or Problem · 1

IT WAS REPORTED THAT THE PATIENT UNDERWENT LEFT HIP ARTHOPLASTY AND EXPERIENCED A URINARY TRACT INFECTION TWO WEEKS POST IMPLANTATION. THE PATIENT WAS TREATED WITH ANTIBIOTICS, AND THE ISSUE RESOLVED WITHIN ONE WEEK. NO ADDITIONAL INFORMATION IS AVAILABLE.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
699133	36MM COCR BIOMET FEM HD +6 NK	PROSTHESIS, HIP	KWA	BIOMET UK LTD.	N/A	3229357

Patients

Seq	Age	Sex	Outcome	Treatment
1	65 YR		Required Intervention