MAUDE Adverse Event Report: FH INDUSTRIE ARROW; GLENOSPHERE COCR D42

Model Number 265152 - CoCr GLENOSPHERE, Ø42

Device Problems Incomplete or Missing Packaging (2312); Device Packaging Compromised (2916); Device Contaminated During Manufacture or Shipping (2969)

Patient Problem Not Applicable (3189)

Event Date 10/10/2017

Event Type  malfunction  

Event Description

Des résidus blancs ont été observés sur plusieurs implants.Le chirurgien a dû en nettoyer un avant de l'implanter.White residues were present on several implants.The surgeon had to wash one in order to implant it.

• Brand Name: ARROW
• Type of Device: GLENOSPHERE COCR D42
• Manufacturer (Section D): FH INDUSTRIE; 6 rue nobel; quimper, 29000 ; FR 29000
• Manufacturer (Section G): FH INDUSTRIE; 6 rue nobel; quimper, 29000 ; FR 29000
• Manufacturer Contact: renaud ruillier ; 3 rue de la forêt; heimsbrunn, 68990 ; FR 68990
• MDR Report Key: 7322852
• MDR Text Key: 102123479
• Report Number: 3003898228-2017-00015
• Device Sequence Number: 1
• Product Code: KWS
• UDI-Device Identifier: 03661489651526
• UDI-Public: (01)03661489651526(17)180329(10)D00039-AND-(01)003661489651526(17)180929(10)D01966
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K112193
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Reporter Occupation: Health Professional
• Remedial Action: Recall
• Type of Report: Initial
• Report Date: 11/17/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/08/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/29/2018
• Device Model Number: 265152 - CoCr GLENOSPHERE, Ø42
• Device Catalogue Number: 265152
• Device Lot Number: D00039 AND D01966
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/14/2013
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1