MAUDE Adverse Event Report: AESCULAP IMPLANT SYSTEMS EXCIA T PLASMAPORE 12/14 SIZE 13MM; HIP ENDOPROSTHETICS

Model Number NU213T

Device Problem Failure To Adhere Or Bond (1031)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Type  malfunction  

Manufacturer Narrative

Manufacturing site evaluation: evaluation on-going.

Event Description

Country of complaint: (b)(6).On (b)(6) 2016, the patient underwent a implantation.At the time of the patient's check-up, the x-ray showed that the prosthesis had sunk.Components in use listed as concomitant devices are: nu213t / excia t plasmapore 12/14 size 13mm; nv058t / plasmafit poly cup size 58mm k; nv207e / vitelene insert k 32mm sym; nk561d / biolox delta prosth.Head 12/14 32mm m.

Manufacturer Narrative

Due to the circumstances that the devices are not available an investigation is not possible.The device quality and manufacturing history records have been checked for all available lot numbers.The device history file has been checked and found to be according to our specification valid at the time of production.No similar incidents have been filed with products from these batches.The mentioned failure is most probably patient, respective user related.A root cause for this failure could be a bad bone condition of the patient.Another root cause could be the wrong preparation of the bone bed by the surgeon or a too low hammered implant.According to (b)(4) a capa is not necessary.

• Brand Name: EXCIA T PLASMAPORE 12/14 SIZE 13MM
• Type of Device: HIP ENDOPROSTHETICS
• Manufacturer (Section D): AESCULAP IMPLANT SYSTEMS; po box 40; tuttlingen, 78501 ; GM 78501
• Manufacturer (Section G): AESCULAP AG; po box 40; tuttlingen, 78501 ; GM 78501
• Manufacturer Contact: nicole broyles ; 615 lambert pointe drive; hazelwood, MO 63042 ; 3145515988
• MDR Report Key: 6038389
• MDR Text Key: 57802875
• Report Number: 3005673311-2016-00184
• Device Sequence Number: 1
• Product Code: LZO
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: K140915
• 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,Followup
• Report Date: 06/28/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/18/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: NU213T
• Device Catalogue Number: NU213T
• Device Lot Number: 52191854
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Distributor Facility Aware Date: 10/07/2016
• Device Age: 9 MO
• Date Manufacturer Received: 09/19/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/22/2016
• 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
• Treatment: NK561D / BIOLOX DELTA PROSTH.HEAD 12/14 32MM M; NU213T / EXCIA T PLASMAPORE 12/14 SIZE 13MM; NV207E / VITELENE INSERT K 32MM SYM
• Patient Outcome(s): Other
• Patient Age: 55 YR