MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA AMISTEM COLLARED STEM, HA COATED STEM SIZE 1 STD; CEMENTLESS FEMORAL STEM

Catalog Number	01.18.231
Health Effect - Clinical Code	Joint Disorder (2373)
Date of Event	08/23/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Additional information received on 05 september 2017 and includes: this patient had previous hip surgery due to her hip anatomy (dysplastic hip).Batch reviews performed on 18 september 2017.Lot 166465: (b)(4) items manufactured and released on 01 february 2017.Expiration date: 2022-01-23.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.Mectacer biolox delta ceramic ball head 12/14 ø 32 size s -4, code 01.29.204, lot.165967 (k112115) (b)(4) items manufactured and released on 05 january 2017.Expiration date: 2021-12-19.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
Post-op the surgeon determined the leg length was off.The surgeon revised the stem and head.The surgery was completed successfully.

• Brand Name: AMISTEM COLLARED STEM, HA COATED STEM SIZE 1 STD
• Common Device Name: CEMENTLESS FEMORAL STEM
• Manufacturer (Section D): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, 6874 ; SZ 6874
• MDR Report Key: 6878297
• Report Number: 3005180920-2017-00524
• Device Sequence Number: 13658020
• Product Code: LZO
• UDI-Device Identifier: 07630030804564
• UDI-Public: 07630030804564
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• PMA/510(K) Number: K121011
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Device Explanted Year: 2017
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 09/20/2017

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: 01/23/2022
• Device Catalogue Number: 01.18.231
• Device Lot Number: 166465
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 08/23/2017
• Initial Report FDA Received Date: 09/20/2017
• 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