MAUDE Adverse Event Report: AESCULAP IMPLANT SYSTEMS COLLECT.NO.QAS IMPLANTS FROM COMPETITORS; MISCELLANEOUS AESCULAP

Model Number AE-QAS-COMPET-IMP

Device Problem Metal Shedding Debris (1804)

Patient Problem Pain (1994)

Event Date 10/13/2017

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Manufacturing site evaluation: evaluation on-going device not returned.

Event Description

Country of complaint: (b)(6).The patient has suffered on increasing pain since 2010.Several blood analysis have been made.The first one in (b)(6) 2016 proved cobalt and chrome in the blood as well as the following analysis in (b)(6) 2017.The blood levels of cobalt and chrome are both strikingly increased.Components in use listed as concomitant devices are: ae-qas-compet-imp / collect.No.Qas implants from competitors nc285t / metha ¿cap 12/14 135°/0° size 5.

• Brand Name: COLLECT.NO.QAS IMPLANTS FROM COMPETITORS
• Type of Device: MISCELLANEOUS AESCULAP
• Manufacturer (Section D): AESCULAP IMPLANT SYSTEMS; po box 40; tuttlingen, 78501 ; GM 78501
• Manufacturer (Section G): AESCULAP IMPLANT SYSTEMS; po box 40; tuttlingen, 78501 ; GM 78501
• Manufacturer Contact: nicole broyles ; 615 lambert pointe drive; hazelwood, MO 63042
• MDR Report Key: 7130365
• MDR Text Key: 95743194
• Report Number: 9610612-2017-00619
• Device Sequence Number: 1
• Product Code: LWJ
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: K080584
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 12/19/2017

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: Health Professional
• Device Model Number: AE-QAS-COMPET-IMP
• Device Catalogue Number: AE-QAS-COMPET-IMP
• Was Device Available for Evaluation?: No
• Distributor Facility Aware Date: 12/12/2017
• Initial Date Manufacturer Received: 12/08/2017
• Initial Date FDA Received: 12/19/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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
• Patient Outcome(s): Other
• Patient Age: 66 YR