EPOLY RINGLOC

Report

Report Number: 0001825034-2017-05545
Event Type: Injury
Date Received: August 2, 2017
Date of Event: July 1, 2017
Report Date: February 9, 2018
Manufacturer: BIOMET ORTHOPEDICS
Product Code: JDI
PMA / PMN Number: PK070399
Removal / Correction Number: N/A
Adverse Event: Yes
Report Source: Manufacturer report
Reporter Location: MI, US
Reporter Occupation: PHYSICIAN

Narratives

Additional Manufacturer Narrative · 1

(B)(4). CUSTOMER HAS INDICATED THAT THE PRODUCT WILL NOT BE RETURNED TO ZIMMER BIOMET FOR INVESTIGATION. THE INVESTIGATION IS IN PROCESS. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A FOLLOW-UP MDR WILL BE SUBMITTED. CONCOMITANT PRODUCT(S): A 14-103662 UNIVERSAL SHELL 860870. A 103532 TI LOW PROFILE SCREW 140280. A 51-10460 TAPERLOC STEM 6028664. A 11-363663 COCR FEMORAL HEAD 335580.

Additional Manufacturer Narrative · 1

THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. REPORTED EVENT WAS UNABLE TO BE CONFIRMED. DEVICE HISTORY RECORD (DHR) WAS REVIEWED AND NO DISCREPANCIES RELEVANT TO THE REPORTED EVENT WERE FOUND. REVIEW OF COMPLAINT HISTORY DETERMINED THAT NO FURTHER ACTION IS REQUIRED AS NO TRENDS WERE IDENTIFIED. ROOT CAUSE WAS UNABLE TO BE DETERMINED. 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 A PATIENT'S HIP ARTHROPLASTY WAS REVISED 3 WEEKS POST-IMPLANTATION DUE TO PAIN, INCISION REDNESS AND DRAINAGE SECONDARY TO INFECTION. DURING THE PROCEDURE, SIGNIFICANT CLOUDY FLUID WAS ENCOUNTERED. THE FEMORAL HEAD AND LINER WERE EXCHANGED.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
541174	EPOLY RINGLOC	PROSTHESIS, HIP	JDI	BIOMET ORTHOPEDICS	N/A	009630

Patients

Seq	Age	Sex	Outcome	Treatment
1	48 YR		Hospitalization\| R