MAUDE Adverse Event Report: AESCULAP IMPLANT SYSTEMS COLUMBUS RP TIBIAL PLATEAU CEMENTED T1; TIBIA IMPLANTS COLUMBUS

Model Number NN271K

Device Problem Detachment Of Device Component (1104)

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

Event Date 05/03/2017

Event Type  malfunction  

Manufacturer Narrative

Reported device not marketed in the u.S., however, similar devices or devices that share components, raw materials, process methods or any other technological characteristics with a medical device that is registered within the u.S.(b)(4).Manufacturing site evaluation: evaluation on-going.Device not returned.

Event Description

(b)(6).It was reported that a revision surgery was required due to a columbus inlay spinout.Components in use listed as concomitant devices are: nn271k / columbus rp tibial plateau cemented t1, nn261k / tibial obturator d12mm, nn910k / columbus cr narrow femur cemented f5nr.

Manufacturer Narrative

Investigation: according to the reference photos received, we found that the slot is damaged.Additionally we found visible damge and unknown residues.Batch history review: the device quality and manufacturing history records have been checked for all the lot numbers and found to be according to the specification, valid at the time of production.Conclusion and root cause: the root cause of the problem is most probably patient related.Rational: according to the quality standard and dhr files, a material defect and production error can be excluded.No similar incidents have been filed with products from this batch.We assume the traumatic influences as a causal factor.No capa is necessary.

• Brand Name: COLUMBUS RP TIBIAL PLATEAU CEMENTED T1
• Type of Device: TIBIA IMPLANTS COLUMBUS
• 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: 6609629
• MDR Text Key: 76721532
• Report Number: 9610612-2017-00309
• Device Sequence Number: 1
• Product Code: HSX
• Combination Product (y/n): N
• Reporter Country Code: AU
• 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: 04/17/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/02/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 10/01/2022
• Device Model Number: NN271K
• Device Catalogue Number: NN271K
• Device Lot Number: 51889226
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Distributor Facility Aware Date: 05/30/2017
• Device Age: 4 YR
• Date Manufacturer Received: 05/03/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/10/2012
• 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): Required Intervention
• Patient Age: 75 YR