MAUDE Adverse Event Report: AESCULAP IMPLANT SYSTEMS COLUMBUS CR/PS TIB.PLAT.PLASMAPORE T3; TIBIA IMPLANTS COLUMBUS

Model Number NN085K

Device Problems Fracture (1260); Material Integrity Problem (2978)

Patient Problems Bone Fracture(s) (1870); Hip Fracture (2349)

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

Country of complaint: usa.Patient is (b)(6) female.She primary surgery on (b)(6) 2017 and we used a pressfit tibia.The patient fell and fractured her tibia, causing us to have to revise her tibia implant.We revised on (b)(6) 2018 to a cemented tibia with stem and augment.No patient injury.Says there was a delay in surgery, but it was actually only required revision surgery.Additional intervention was reported.

Manufacturer Narrative

Investigation: according to the reference photos received, we found no damage to the implants.Batch history review: the device quality and manufacturing history records have been checked for the lot number and found to be according to the specification, valid at the time of production.Conclusion and root cause: no product is available and therefore an analysis is not possible, but we assume based on the information available, the root cause of this failure is not product related.The root cause of the problem could be patient related.Rational: according to the quality standard and dhr files, a material defect or production error can be excluded.No similar incidents have been filed with products form this batch.Unfortunately, due to a lack of data, we can not determine the exact cause.No capa is necessary.

• Brand Name: COLUMBUS CR/PS TIB.PLAT.PLASMAPORE T3
• Type of Device: TIBIA IMPLANTS COLUMBUS
• Manufacturer (Section D): AESCULAP IMPLANT SYSTEMS; po box 40; tuttlingen, 78501 ; GM 78501
• MDR Report Key: 7301114
• MDR Text Key: 101263063
• Report Number: 9610612-2018-00050
• Device Sequence Number: 1
• Product Code: JWH
• Combination Product (y/n): N
• PMA/PMN Number: K030367
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Type of Report: Initial,Followup
• Report Date: 04/27/2018

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 Expiration Date: 05/01/2021
• Device Model Number: NN085K
• Device Catalogue Number: NN085K
• Device Lot Number: 51762406
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 01/31/2018
• Device Age: 5 YR
• Initial Date Manufacturer Received: 01/30/2018
• Initial Date FDA Received: 02/27/2018
• Supplement Dates Manufacturer Received: 01/30/2018
• Supplement Dates FDA Received: 04/27/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 61 YR