MAUDE Adverse Event Report: AESCULAP IMPLANT SYSTEMS UNIVATION F MENISCAL COMP.T3 RM/LM 7MM; KNEE ENDOPROSTHETICS

Model Number NL472

Device Problem Device Operates Differently Than Expected (2913)

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

Event Date 10/17/2016

Event Type  malfunction  

Manufacturer Narrative

Manufacturing site evaluation: evaluation on-going.

Event Description

Country of complaint: (b)(6).It was reported that during a knee surgery, the inlay would not fit properly.There was an audible snap sound; however microscopic movement of the inlay was still visible.Changing from a 7mm to an 8mm did not bring any improvement.Components in use listed as concomitant devices are: no187k / univation xf femur cemented f3 lm.No164k / univation xf tibia cemented t3 lm.Nl472 / univation f meniscal comp.T3 rm/lm 7mm (2).

Manufacturer Narrative

Investigation: due to the circumstances that we did not receive any devices, a detailed investigation is not possible.This case was discussed with a specialist from the marketing department.Conclusion and root cause: a definitive conclusion and root cause could not be determined because we did not receive any devices for a detailed investigation.Based on our quality standards we exclude a manufacturing error.Rational: according to the responsible product manager, the mentioned movement of the meniscal component, recognized by the user , is caused due to a tolerance within specification.Depending on the tolerance the play is higher or lower.This situation has already been tested in a biomechanic test in respect to abrasion.Result: the abrasion results of the components with play are permitted for this product.Furthermore, the play between components will decrease because the body temperature (37°c) lead to an extension of the metal and pe component.Unlikely but possible in general, the root cause of this failure could be that cement residues or soft tissues at the joining point, prevented a proper fit of the component.No capa is necessary.

• Brand Name: UNIVATION F MENISCAL COMP.T3 RM/LM 7MM
• Type of Device: KNEE 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: 6109495
• MDR Text Key: 60622506
• Report Number: 3005673311-2016-00195
• Device Sequence Number: 1
• Product Code: HRY
• Combination Product (y/n): N
• PMA/PMN Number: K081293
• 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: 09/20/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/17/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: NL472
• Device Catalogue Number: NL472
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Distributor Facility Aware Date: 11/02/2016
• Date Manufacturer Received: 10/20/2016
• 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
• Treatment: NL472 / UNIVATION F MENISCAL COMP. T3 RM/LM 7MM; NO164K / UNIVATION XF TIBIA CEMENTED T3 LM; NO187K / UNIVATION XF FEMUR CEMENTED F3 LM
• Patient Outcome(s): Other