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

Model Number NO160K

Device Problem Break (1069)

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

Country complaint: (b)(6).It is reported that the tibia broke.Operating room reports and x-ray will be received soon.

Manufacturer Narrative

Additional mdr added, additional information follow up.All med watch submissions related to this related to this report are: (b)(4).The device for investigation was not returned because the univation xf tibia cemented t5 rm is till implanted.No x-rays are available.Post-operative medical intervention will be necessary.Due to the circumstance that the device was not returned for investigation, a failure is not possible to determine.A review of the device quality and manufacturing history records was not possible because the lot number is unknown.Based on the information available it is hardly possible to determine a conclusion or root cause.There are possible reason for a tibia fracture: too deep a cut.Too deep a cut on the sagittal cut with the reciprocating saw.Too high forces while tibia final preparation (hammer) or while final tibia implantation.According to sop a capa is not necessary.

Event Description

Country of complaint: (b)(6).Additional mdr added, additional information follow-up.Components in use listed as concomitant devices are: no183k / univation xf femur cemented f4 rm.Nl473 / univation f meniscal comp.T4 rm/lm 7mm.

• Brand Name: UNIVATION XF TIBIA CEMENTED T5 RM
• 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
• MDR Report Key: 7114385
• MDR Text Key: 95058937
• Report Number: 9610612-2017-00596
• Device Sequence Number: 1
• Product Code: HRZ
• 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: 01/26/2018

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: NO160K
• Device Catalogue Number: NO160K
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Distributor Facility Aware Date: 12/04/2017
• Initial Date Manufacturer Received: 11/27/2017
• Initial Date FDA Received: 12/13/2017
• Supplement Dates Manufacturer Received: 01/22/2018
• Supplement Dates FDA Received: 02/08/2018
• 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