MAUDE Adverse Event Report: AESCULAP IMPLANT SYSTEMS COLUMBUS CR/PS TIB.PLAT.PLASMAPORE T1; TIBIA IMPLANTS COLUMBUS

Model Number NN081K

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

Patient Problems Bone Fracture(s) (1870); Patient Problem/Medical Problem (2688)

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) year old female.We used a columbus pressfit tibia for her primary surgery on (b)(6) 2017.The patient had osteopenia which developed into osteoporosis.The tibia implant subsided and needed a revision surgery.We revised with a cemented tibia with stem and augments.No injury to patient.Complaint form states delay in surgery, but only need revision surgery.Additional intervention required.

Manufacturer Narrative

Investigation: according to photos and x-rays received, we found that the tibial component has subsided.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 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.Rational: according to the quality standard and dhr files a material defect or production error can be excluded.There is the possibility that the osteopenia developed into osteoporosis as the causal factor.No capa is necessary.

• Brand Name: COLUMBUS CR/PS TIB.PLAT.PLASMAPORE T1
• Type of Device: TIBIA IMPLANTS COLUMBUS
• Manufacturer (Section D): AESCULAP IMPLANT SYSTEMS; po box 40; tuttlingen, 78501 ; GM 78501
• MDR Report Key: 7301109
• MDR Text Key: 101174376
• Report Number: 9610612-2018-00057
• 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: 04/25/2018

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: NN081K
• Device Catalogue Number: NN081K
• Device Lot Number: 52176995
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 02/05/2018
• Device Age: 2 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: 04/25/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 74 YR