MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA AMISTEM COLLARED STEM, HA COATED STEM SIZE 0 STD; CEMENTLESS FEMORAL STEM

Catalog Number	01.18.230
Medical Device Problem Code	Device Issue (2379)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	07/20/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
On 17 august 2017 the r&d project manager performed a preliminary investigation based on the available images and commented as follows: in the images of both braoch and stem no particular sign can be noted.We will wait to receive the stem for dimensional controls: that in order to confirm the equivalence between broach and stem.To date, the root cause of the event cannot be determined.Batch review performed on 18 august 2017.Lot 170841: (b)(4) items manufactured and released on 06 april 2017.Expiration date: 2022-03-28.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been already sold without any similar reported event.
Event or Problem Description
The surgeon tried to implant the amistem-h collared stem size 0 after rasping, but the stem was not able to fit in the canal prepared with broach size 0.It was floated about 5mm height.The surgeon simply change for new stem size 00 and it was fit and fixed strongly.Due to this event, the surgery was prolonged about 10 minutes.The surgery was completed successfully.
Additional Manufacturer Narrative
On 15 september 2017 the r&d project manager performed a visual inspection of the retrieved stem and commented as follows: no particular signs can be noted, except some scratches on the neck probably due to the removal of the stem.A dimensional control has been performed, which identified nor anomalies nor defects.According to the dimensional control, the stem and the broach conform to the drawing.The root cause of the event cannot be determined.

• Brand Name: AMISTEM COLLARED STEM, HA COATED STEM SIZE 0 STD
• Common Device Name: CEMENTLESS FEMORAL STEM
• Manufacturer (Section D): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, 6874 ; SZ 6874
• MDR Report Key: 6803628
• Report Number: 3005180920-2017-00457
• Device Sequence Number: 2065947
• Product Code: LZO
• UDI-Device Identifier: 07630030804557
• UDI-Public: 07630030804557
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K121011
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 09/15/2017

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
• Operator of Device: Health Professional
• Device Expiration Date: 03/28/2022
• Device Catalogue Number: 01.18.230
• Device Lot Number: 170841
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/18/2017
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 07/20/2017
• Supplement Date Received by Manufacturer: 07/20/2017
• Initial Report FDA Received Date: 08/18/2017
• Supplement Report FDA Received Date: 09/15/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Age: 64 YR