MAUDE Adverse Event Report: BIOMET UK LTD. ARCOM XL HI-WALL LINER RINGLOC-X SZ 46MM (RINGLOC SIZE 22); PROSTHESIS, HIP

Model Number N/A

Device Problem Component or Accessory Incompatibility (2897)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 06/28/2016

Event Type  malfunction  

Manufacturer Narrative

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.Pma 510(k): this device is not manufactured by zimmer biomet in the united states; however, we are filing this report as zimmer biomet 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 3002806535-2016-00634 / 00635).Product requested, not yet returned.

Event Description

The acetabular liner would not assemble correctly with the acetabular shell during the procedure.There was no delay in procedure or patient injury.The procedure was completed with a different acetabular liner.

Manufacturer Narrative

(b)(4).

Manufacturer Narrative

(b)(4).Review of manufacturing history found no evidence of product nonconformance.Evaluation of the returned liner revealed that it was well seated in the shell with no movement, indicating the liner and shell combination were correct.A root cause could not be determined and the complaint could not be confirmed.

• Brand Name: ARCOM XL HI-WALL LINER RINGLOC-X SZ 46MM (RINGLOC SIZE 22)
• Type of Device: PROSTHESIS, HIP
• Manufacturer (Section D): BIOMET UK LTD.; waterton industrial estates; bridgend CF31 3XA; UK CF31 3XA
• Manufacturer (Section G): BIOMET UK LTD.; waterton industrial estates; bridgend CF31 3XA; UK CF31 3XA
• Manufacturer Contact: daniel tilbury ; waterton industrial estates; bridgend ; 0441656655
• MDR Report Key: 5834823
• MDR Text Key: 50814541
• Report Number: 3002806535-2016-00634
• Device Sequence Number: 1
• Product Code: LPH
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: PN/A
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 10/01/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Expiration Date: 10/31/2020
• Device Model Number: N/A
• Device Catalogue Number: XL-052846
• Device Lot Number: 3664781
• Other Device ID Number: SEE NARRATIVE IN H10
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/01/2016
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 06/29/2016
• Initial Date FDA Received: 07/29/2016
• Supplement Dates Manufacturer Received: Not provided; Not provided
• Supplement Dates FDA Received: 11/01/2016; 12/30/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/15/2015
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Patient Age: 81 YR