FDA Adverse Event Malfunction Summary report: N

ARCOM XL HI-WALL LINER RINGLOC-X SZ 54MM (RINGLOC SIZE 24)

MDR report key: 5592163 · Received April 20, 2016

Report

Report Number: 3002806535-2016-00187
Event Type: Malfunction
Date Received: April 20, 2016
Date of Event: March 22, 2016
Report Date: October 1, 2016
Manufacturer: BIOMET UK LTD.
Product Code: LPH
PMA / PMN Number: PN/A
Removal / Correction Number: N/A
Product Problem: Yes
Report Source: Manufacturer report
Reporter Location: CH
Reporter Occupation: PHYSICIAN

Narratives

Additional Manufacturer Narrative · 1

THIS USER FACILITY IS OUTSIDE OF THE UNITED STATES. CURRENT INFORMATION IS INSUFFICIENT TO PERMIT A CONCLUSION AS TO THE CAUSE OF THE EVENT. REVIEW OF DEVICE HISTORY RECORDS SHOW THAT LOT RELEASED WITH NO RECORDED ANOMALY OR DEVIATION. THIS PRODUCT IS MANUFACTURED BY ZIMMER BIOMET (B)(4) AND IS NOT CLEARED OR DISTRIBUTED IN THE U.S. HOWEVER, THIS REPORT IS BEING SUBMITTED AS ZIMMER BIOMET (B)(4) MANUFACTURES A SIMILAR DEVICE IN THE UNITED STATES UNDER 510K NUMBER K023357. THIS REPORT IS NUMBER 1 OF 2 MDRS FILED FOR THE SAME PATIENT (REFERENCE 3002806535-2016-00187 / 00188). REMAINS IMPLANTED.

Additional Manufacturer Narrative · 1

(B)(4).

Description of Event or Problem · 1

IT WAS REPORTED THAT THE PATIENT UNDERWENT BILATERAL TOTAL HIP ARTHROPLASTIES ON (B)(6) 2016. DURING THE PROCEDURE, THE ACETABULAR LINER WAS LOOSE AND SHOWED MOVEMENT WITHIN THE SHELL. THE ACETABULAR LINER WAS REMOVED AND REPLACED WITH ANOTHER LINER. THE SECOND ACETABULAR LINER ALSO SHOWED MOVEMENT. THERE WAS NO PATIENT INJURY AND THE EVENT RESULTED IN A DELAY OF TWENTY (20) MINUTES.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
248306	ARCOM XL HI-WALL LINER RINGLOC-X SZ 54MM (RINGLOC SIZE 24)	PROSTHESIS, HIP	LPH	BIOMET UK LTD.	N/A	3671486

Patients

Seq	Age	Sex	Outcome	Treatment
1	24 YR