MAUDE Adverse Event Report: AESCULAP IMPLANT SYSTEMS UNIVATION XF TIBIA CEMENTED T5 LM; TIBIA IMPLANTS UNIVATION

Model Number NO166K

Device Problem Fracture (1260)

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

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

(b)(6).There was a fracture of tibia head reported.The patient does not have such severe symptoms at the moment, so there is currently no revision scheduled.Components in use listed as concomitant devices are: no166k / univation xf tibia cemented t5 lm, no188k / univation xf femur cemented f4 lm, nl480 / univation f meniscal comp.T5 rm/lm 8mm.

Manufacturer Narrative

Investigation: several x-ray images are available.This case was also discussed with a specialist from the marketing department.Batch history review: the device quality and manufacturing history records have been checked for the 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: based on the information available it is hardly possible to determine a conclusion and root cause of the failure.We assume that this failure is not product or design related.Rational: there are some possible reasons for a tibia fracture: too deep tibia cut: the tibia is weakened since the bone stock is reduced under the tibia implant.Too deep cut on the sagittal cut with the reciprocating saw.The bone is weakened in those area and increases the risk of fracture.Too high forces while tibia final preparation (hammer) or while final tibia implantation.No capa is necessary.

• Brand Name: UNIVATION XF TIBIA CEMENTED T5 LM
• Type of Device: TIBIA IMPLANTS UNIVATION
• 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: 7305775
• MDR Text Key: 101483122
• Report Number: 9610612-2018-00095
• Device Sequence Number: 1
• Product Code: KRO
• Combination Product (y/n): N
• Reporter Country Code: GM
• 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: 03/14/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/01/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: NO166K
• Device Catalogue Number: NO166K
• Device Lot Number: 52353529
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Distributor Facility Aware Date: 02/19/2018
• Device Age: 6 MO
• Date Manufacturer Received: 02/01/2018
• Was Device Evaluated by Manufacturer?: Yes
• 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