MAUDE Adverse Event Report: AESCULAP AG AS TIBIA OFFSET STEM D20X92 CEMENTLESS STEMS (IMPLANTS) COLUMBUS

Model Number NR180Z

Device Problem Contamination /Decontamination Problem (2895)

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

Event Date 08/14/2018

Event Type  Injury  

Manufacturer Narrative

(b)(4). There is no product on hand, therefore an investigation is not possible. This case was discussed with the quality coordinator and it was determined that during the manufacturing process it is not possible for such a defect to occur. Additionally, there is 100 % final inspection, and if the defect was present it would have been observed. The origins of this foreign contaminant is unknown. The root cause of the event was unable to be determined, since the defect is not manufacturing-related. A batch history review was performed for the batch and there was no related complaints for the this failure against batch number 51858838.

Event Description

It was reported that upon removal from the sterile package that there were "black sand-like or powder-like" debris near threads and within sterile container. The implant was washed with sterile saline which contained antibiotics to remove debris. The device was implanted during surgery. There was no reported harm to patient and a less than 5 minute delay in surgery.

• Brand Name: AS TIBIA OFFSET STEM D20X92 CEMENTLESS
• Type of Device: STEMS (IMPLANTS) COLUMBUS
• Manufacturer (Section D): AESCULAP AG; 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: 7895780
• MDR Text Key: 120960662
• Report Number: 9610612-2018-00412
• Device Sequence Number: 1
• Product Code: KRO
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K101815
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative

Reporter Occupation

• Type of Report: Initial
• Report Date: 09/20/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/20/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes

Device Operator

• Device Expiration Date: 06/01/2022
• Device Model Number: NR180Z
• Device Catalogue Number: NR180Z
• Device Lot Number: 51858838
• Was Device Available for Evaluation?: No

Is the Reporter a Health Professional?

Was the Report Sent to FDA?

• Distributor Facility Aware Date: 08/28/2018
• Device Age: 6 YR
• Event Location: No Information
• Date Manufacturer Received: 08/23/2018
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 08/01/2012
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial

Patient Treatment Data

Date Received: 09/20/2018 Patient Sequence Number: 1