MAUDE Adverse Event Report: AESCULAP IMPLANT SYSTEMS BIOLOX PROSTHESIS HEAD 12/14 32MM S; MPLANTS STANDARD PROSTHESES HE

Model Number NK560

Device Problem Device Operates Differently Than Expected (2913)

Patient Problem Adhesion(s) (1695)

Event Date 06/24/2016

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Evaluation: on going.

Event Description

Country of complaint: (b)(6).Three year_ten month post-operative pronounced capsule adhesions.First surgery (b)(6) 2007.Revision surgery (b)(6) 2011.Additional components to be evaluated are included in concomitant section of report include: nc081t / metha short hip stem p size 1, lot number: 51385443, production date: 05/23/2007, expiration date: 04/30/2011.Nc089k / metha neck 12/14 135deg/7.5deg l retro-r ante, lot number: 51381260, production date: 01/23/2007, expiration date: 12/31/2016.

Manufacturer Narrative

According to the quality specifications for the ball head, the material properties correspond to the specifications that were valid at the time of manufacture.There are no indications of a material defect.

• Brand Name: BIOLOX PROSTHESIS HEAD 12/14 32MM S
• Type of Device: MPLANTS STANDARD PROSTHESES HE
• Manufacturer (Section D): AESCULAP IMPLANT SYSTEMS; po box 40; tuttlingen, 78501 ; GM 78501
• MDR Report Key: 5818049
• MDR Text Key: 50291427
• Report Number: 3005673311-2016-00114
• Device Sequence Number: 1
• Product Code: LWJ
• Combination Product (y/n): N
• PMA/PMN Number: K060918
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 12/18/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 05/31/2017
• Device Model Number: NK560
• Device Catalogue Number: NK560
• Device Lot Number: 51413356
• Was Device Available for Evaluation?: No
• Distributor Facility Aware Date: 07/01/2016
• Initial Date Manufacturer Received: 04/01/2016
• Initial Date FDA Received: 07/23/2016
• Supplement Dates Manufacturer Received: 07/26/2016
• Supplement Dates FDA Received: 12/18/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 54 YR