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

Model Number NU214T

Device Problem Failure To Adhere Or Bond (1031)

Patient Problem No Code Available (3191)

Event Date 07/15/2016

Event Type  malfunction  

Manufacturer Narrative

Manufacturing site evaluation: evaluation on-going.

Event Description

Country of complaint: (b)(6).The patient had a periprosthetic fracture, intra-operatively.It was reported by the surgeon that during the impacting the prosthesis was slipping.After reviewing it with x-rays it was visible that there was a fissure on the femur shaft.Original surgery date reported as (b)(6) 2016.Revision surgery reported as (b)(6) 2016.Components in use listed as concomitant devices are: nu214t - excia t plasmapore 12/14 size 14mm.Nk561d - biolox delta prosth.Head 12/14 32mm m.Nv048t - plasmafit poly cup size 48mm f.Nv202e - vitelene insert f 32mm sym.

Manufacturer Narrative

Investigation: due to the circumstances that the devices are not available an investigation at the implants is not possible.Batch history review: 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.Conclusion and root cause: due to further experiences the mentioned failure is most probably patient, respective user related.Rational: a root cause for this failure could be a bad bone condition of the patient.In the ifu is clearly mentioned: do not use in the presence of: acute osteoporoses or osteomalacia.Another root cause could be a wrong preparation of the bone bed by the surgeon.Corrective action: according to sop (b)(4) a capa is not necessary.

• Brand Name: EXCIA T PLASMAPORE 12/14 SIZE 14MM
• Type of Device: HIP ENDOPROSTHETICS
• Manufacturer (Section D): AESCULAP IMPLANT SYSTEMS; 615 lambert pointe drive; hazelwood MO 63042
• 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: 6094445
• MDR Text Key: 59742089
• Report Number: 3005673311-2016-00187
• 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: 06/21/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/10/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: NU214T
• Device Catalogue Number: NU214T
• Device Lot Number: 52176975
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Device Age: 12 MO
• Date Manufacturer Received: 10/13/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/18/2015
• 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: NU214T / EXCIA T PLASMAPORE 12/14 SIZE 14MM; NV048T / PLASMAFIT POLY CUP SIZE 48MM F; NV202E / VITELENE INSERT F 32MM SYM.
• Patient Outcome(s): Other; Required Intervention
• Patient Age: 74 YR