FDA Adverse Event Malfunction Summary report: N

E1 RINGLOC BIPOLAR 28X51MM

MDR report key: 8705024 · Received June 17, 2019

Report

Report Number: 0001825034-2019-02589
Event Type: Malfunction
Date Received: June 17, 2019
Report Date: September 24, 2019
Manufacturer: ZIMMER BIOMET, INC.
Product Code: LZO
PMA / PMN Number: NA
Product Problem: Yes
Report Source: Manufacturer report
Reporter Location: JA
Reporter Occupation: PHYSICIAN

Narratives

Additional Manufacturer Narrative · 0

THE EVENT IS CONFIRMED WITH PRODUCT RETURNED. UPON VISUAL INSPECTION THE LOCKING RING HAD BEEN REMOVED FROM THE SHELL. NO DEBRIS COULD BE SEEN INSIDE OF THE LOCKING FEATURE OF THE SHELL. THE BEND IN THE LOCKING RING IS AWAY FROM THE CHAMFER AND THE SCRATCHES TO THE UNDERSIDE OF THE LOCKING RING CORRESPOND WITH IMPACTION. DHR WAS REVIEWED AND NO DISCREPANCIES RELEVANT TO THE REPORTED EVENT WERE FOUND. A CORRECTIVE ACTION HAS BEEN INITIATED TO DETERMINE THE ROOT CAUSE.

Description of Event or Problem · 0

NO FURTHER EVENT INFORMATION AVAILABLE AT THE TIME OF THIS REPORT.

Additional Manufacturer Narrative · 1

(B)(4). REPORT SOURCE: (B)(6). THIS PRODUCT IS NOT CLEARED FOR DISTRIBUTION IN THE U.S. HOWEVER, THIS REPORT IS BEING SUBMITTED AS A SIMILAR DEVICE IS CLEARED FOR DISTRIBUTION UNDER 510K NUMBER K921181. CUSTOMER HAS INDICATED THAT THE PRODUCT IS IN PROCESS OF BEING RETURNED TO ZIMMER BIOMET FOR INVESTIGATION. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A FOLLOW-UP MDR WILL BE SUBMITTED.

Description of Event or Problem · 1

IT WAS REPORTED THAT WHEN THE STERILE PACKAGING OF THIS PRODUCT WAS OPENED, RING OF BIPOLAR CUP HAD COME OFF AND BENT. THIS SURGERY WAS FINISHED WITH BACKUP PRODUCT. NO ADVERSE EVENTS HAVE BEEN REPORTED AS A RESULT OF THE MALFUNCTION.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
498682	E1 RINGLOC BIPOLAR 28X51MM	PROSTHEIS HIP	LZO	ZIMMER BIOMET, INC.	N/A	988520

Patients

Seq	Age	Sex	Outcome	Treatment
1