MAUDE Adverse Event Report: AESCULAP AG AS TIBIA OFFSET STEM D20X92 CEMENTLESS; KNEE ENDOPROSTHETICS

Model Number NR180Z

Device Problem Manufacturing, Packaging or Shipping Problem (2975)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 02/24/2020

Event Type  malfunction  

Manufacturer Narrative

Manufacturing site evaluation: investigation on-going.Additional information / investigation results will be provided in a supplemental report.

Event Description

It was reported that there was an issue with as tibia offset stem.The reported incident was against catalog item nr180z.It was reported that the stem was packaged in a clear cylinder.The container had significant residue on the inside walls.The stem itself was discolored brown, not standard gold color and had considerable white residue or powder on it.The surgeon was hesitant to use it.This incident did cause a 10 minute delay in surgery.The surgeon used the same stem the allegation was against since there was no back-up in the facility.The patient outcome was good, there were no complications noted.Additional information was not provided nor available / was not available.The adverse event/malfunction is filed under (b)(4).

Manufacturer Narrative

General information: the following information was provided by the subsidiary: "residue on the inside walls! the stem was packaged in a clear cylinder.The container had significant residue on the inside walls.The stem itself was discolored brown, not standard gold color and had considerable white residue or powder on it.Surgeon was hesitant to use product considering recall".Consequences for the patient: according to the available information, there were no negative consequences for patient.Investigation: investigation is not possible -> no product at hand.There are no pictures available.Batch history review: the device quality and manufacturing history records have been checked for the available lot number and found to be according to our specification valid at the time of production.No similar incidents have been filed with products from this batch.Conclusion and root cause: based on the information available it is not possible to determine a definitive root cause for the failure.It could be possible that the mentioned failure is package related (related due to several delivery processes).Rationale: on the basis of the current information and without a product for investigation, a clear conclusion can not be drawn.The device history records have been checked and no abnormalities could be observed.From our experience (on the basis of similar cases described) it could be possible that the mentioned "residues on the inside walls" resulting from contact between the implant and the package.On the basis of the manufacturing date (2014) most probably the complained device is part from a loan service.Therefore it could be possible that a high level of workload due to several delivery processes lead to a complete damage of the packaging -> oxygen reached to the product and lead to the mentioned discoloration.Corrective action: m-4-2-04-000-0 (corrective action & preventive action) a capa is not necessary.

• Brand Name: AS TIBIA OFFSET STEM D20X92 CEMENTLESS
• Type of Device: KNEE ENDOPROSTHETICS
• Manufacturer (Section D): AESCULAP AG; po box 40; tuttlingen, 78501 ; GM 78501
• MDR Report Key: 9824497
• MDR Text Key: 183254735
• Report Number: 9610612-2020-00075
• Device Sequence Number: 1
• Product Code: KRO
• Combination Product (y/n): N
• PMA/PMN Number: K101815
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 06/03/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/12/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: NR180Z
• Device Catalogue Number: NR180Z
• Device Lot Number: 52068326
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 05/12/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1