MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA AMISTEM H, HA COATED STEM SIZE 5 STD; CEMENTLESS FEMORAL STEM

Catalog Number	01.18.135
Health Effect - Clinical Code	Joint Disorder (2373)
Date of Event	08/15/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Batch review performed on (b)(6) 2017.Lot 103232: 60 items manufactured and released on (b)(6) 2010.Expiration date: (b)(6) 2015.No anomalies found related to the problem.To date, all items of the same lot have been already sold without any similar reported event.
Event or Problem Description
The patient came in complaining of pain.The surgeon determined the stem was loose.The cause of the loosening is unknown.The surgeon removed the stem, head and liner.The surgery was completed successfully.
Additional Manufacturer Narrative
On 02 october 2017 the r&d project manager performed a visual inspection of the retrieved items and commented as follows: the stem showed a coating almost totally absorbed, except some areas in the distal part.Big grooves in the lower taper and signs on the neck are visible for the extraction of the stem.The dm liner showed a yellowed external surface and some small sign.The metal head did not move well, probably due to the deformed liner after washing/sterilization or for third body between the two surfaces.From the received components it is not possible to determine the root cause of the event.

• Brand Name: AMISTEM H, HA COATED STEM SIZE 5 STD
• Common Device Name: CEMENTLESS FEMORAL STEM
• Manufacturer (Section D): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, 6874 ; SZ 6874
• MDR Report Key: 6860920
• Report Number: 3005180920-2017-00514
• Device Sequence Number: 116041
• Product Code: LZO
• UDI-Device Identifier: 07630030804564
• UDI-Public: 07630030804564
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K093944
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2011
• Device Explanted Year: 2017
• Reporter Type: Manufacturer
• Report Source: other
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 10/20/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Expiration Date: 10/31/2015
• Device Catalogue Number: 01.18.135
• Device Lot Number: 103232
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/20/2017
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 08/15/2017
• Supplement Date Received by Manufacturer: 08/15/2017
• Initial Report FDA Received Date: 09/13/2017
• Supplement Report FDA Received Date: 10/20/2017
• 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: Required Intervention