MAUDE Adverse Event Report: AESCULAP IMPLANT SYSTEMS UNIVATION XF TIBIA CEMENTED T1 RM; TIBIA IMPLANTS UNIVATION

Model Number NO156K

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

Country of complaint: (b)(6).The fracture was fixed with a plate.Further information next week.Components in use listed as concomitant devices are: no156k / univation xf tibia cemented t1 rm no181k / univation xf femur cemented f2 rm nl470 / univation f meniscal comp.T1 rm/lm 7mm.

Manufacturer Narrative

Investigation: several x-rays 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 and been fund 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 this failure.We assume that this failure is not product or design related.Rational: there are some possible reason for a tibia fracture: tibia cut too deeply: 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 this area and increased the risk of fracture.Too high forces while the final preparation (hammer) or during final tibia implantation.No capa is necessary.

• Brand Name: UNIVATION XF TIBIA CEMENTED T1 RM
• Type of Device: TIBIA IMPLANTS UNIVATION
• Manufacturer (Section D): AESCULAP IMPLANT SYSTEMS; po box 40; tuttlingen, 78501 ; GM 78501
• MDR Report Key: 7305781
• MDR Text Key: 101365073
• Report Number: 9610612-2018-00097
• Device Sequence Number: 1
• Product Code: KRO
• Combination Product (y/n): N
• 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: 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: NO156K
• Device Catalogue Number: NO156K
• Device Lot Number: 52138524
• Was Device Available for Evaluation?: No
• Distributor Facility Aware Date: 02/20/2018
• Device Age: 2 YR
• Date Manufacturer Received: 02/01/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: NL470 / UNIVATION F MENISCAL COMP.T1 RM/LM 7MM; NO156K / UNIVATION XF TIBIA CEMENTED T1 RM; NO181K / UNIVATION XF FEMUR CEMENTED F2 RM
• Patient Outcome(s): Other