MAUDE Adverse Event Report: BIOMET UK LTD. ARCOM XL HI-WALL LINER RINGLOC-X SZ 54MM (RINGLOC SIZE 24); PROSTHESIS, HIP

Model Number N/A

Device Problems Component or Accessory Incompatibility (2897); Unintended Movement (3026)

Patient Problem No Information (3190)

Event Date 03/22/2016

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.Device availability - the device is reportedly available for evaluation; however, it has not been received by biomet to date.In the event that the device is received and evaluated, a follow-up report will be send to the fda to provide results.Pma 510(k):- 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 in (b)(4) manufactures a similar device in the united states under 510k number k023357.This report is number 2 of 2 mdrs filed for the same patient (reference 3002806535-2016-00187 / 00188).

Event Description

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.

Manufacturer Narrative

(b)(4).

Manufacturer Narrative

(b)(4).Manufacturing history found no evidence of product nonconformance.Examination of the returned device revealed evidence of heavy damage, most likely occurring during extraction of the implant.Dimensional analysis found device conformed to print specifications.A conclusive root cause cannot be determined due to the level of damage to the device and available information.

• Brand Name: ARCOM XL HI-WALL LINER RINGLOC-X SZ 54MM (RINGLOC SIZE 24)
• 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: 5592164
• MDR Text Key: 43180378
• Report Number: 3002806535-2016-00188
• 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: 10/26/2020
• Device Model Number: N/A
• Device Catalogue Number: XL-053654
• Device Lot Number: 3671486
• 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: 03/22/2016
• Initial Date FDA Received: 04/20/2016
• Supplement Dates Manufacturer Received: Not provided; Not provided
• Supplement Dates FDA Received: 10/31/2016; 12/09/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/04/2015
• 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: 24 YR
• Patient Weight: 60