MAUDE Adverse Event Report: BIOMET ORTHOPEDICS ARCOM RIMLOC 28MM 10DEG SZ2; PROSTHESIS, HIP

Model Number N/A

Device Problem Component or Accessory Incompatibility (2897)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 03/05/2016

Event Type  malfunction  

Manufacturer Narrative

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.Quantity 2 of this item/lot.This report is number 2 of 3 mdrs filed for the same event (reference 1825034-2016-01092 / 02725/ 02726).

Event Description

It was reported that during a hip revision procedure, three acetabular liners would not properly seat in the acetabular cup.A smaller liner was cemented into the cup to complete the procedure without delay.

Manufacturer Narrative

Visual inspection of the two returned liners noted a fractured nub on one and a damaged nub on the other, this was likely caused when attempting to seat the liners.Review of manufacture history records found no deviation or anomaly, the products likely left biomet conforming to print.It is possible that the liners were not aligned correctly, however, a definitive root cause cannot be identified.

• Brand Name: ARCOM RIMLOC 28MM 10DEG SZ2
• Type of Device: PROSTHESIS, HIP
• Manufacturer (Section D): BIOMET ORTHOPEDICS; 56 e. bell drive; warsaw IN 46582
• Manufacturer (Section G): BIOMET ORTHOPEDICS; 56 e. bell drive; warsaw IN 46582
• Manufacturer Contact: megan haas ; 56 e. bell drive; warsaw, IN 46582 ; 5743726700
• MDR Report Key: 5813595
• MDR Text Key: 50177491
• Report Number: 0001825034-2016-02725
• Device Sequence Number: 1
• Product Code: JDI
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: PK911718
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 06/16/2016

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: 09/30/2018
• Device Model Number: N/A
• Device Catalogue Number: 11-105212
• Device Lot Number: 599450
• Other Device ID Number: N/A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/16/2016
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 06/16/2016
• Initial Date FDA Received: 07/21/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 09/16/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/28/2013
• 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: 80 YR