MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA STEM COLLARED HA COATED STD STEM SIZE 4; CEMENTLESS HIP STEM

Catalog Number	01.18.234
Health Effect - Clinical Codes	Failure of Implant (1924); Unspecified Infection (1930)
Date of Event	03/01/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Batch review performed on 28 may 2018; lot 154535: (b)(4) items manufactured and released on 01 december 2015.Expiration date: 2020-11-18; 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 patient came in complaining of instability 1 year and 8 months after the previous surgery.The surgeon determined the stem had loosened proximally.A small pedestal formed at the distal end of the stem.The surgeon revised the stem, head and liner.The surgery was completed successfully.Note: second revision surgery for the patient, the first one was due to infection (stem, head and liner replaced) (b)(4).
Additional Manufacturer Narrative
Clinical evaluation reported on 01 june 2018 by medical affairs director: partial hip revision surgery (stem, head and liner) 1 year and 8 months after septic revision.Radiographic images provided show the presence of radiolucent lines in the proximal region and signs of stress shielding suggesting implant mobilization.The stem is not completely seated in the femoral canal and therefore the load pattern is significantly different from the design conditions.The reason of this position cannot be determined on the basis of information received, and there was probably a medical reason for this choice.With such insufficient proximal bone stock a longer stem could have provided better support.

• Brand Name: STEM COLLARED HA COATED STD STEM SIZE 4
• Common Device Name: CEMENTLESS HIP STEM
• Manufacturer (Section D): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, switzerland 6874 ; SZ 6874
• MDR Report Key: 7553221
• Report Number: 3005180920-2018-00387
• Device Sequence Number: 16692846
• Product Code: LZO
• UDI-Device Identifier: 07630030804595
• UDI-Public: 07630030804595
• 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: 2016
• Device Explanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 06/26/2018

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 Catalogue Number: 01.18.234
• Device Lot Number: 154535
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 05/01/2018
• Supplement Date Received by Manufacturer: 05/01/2018
• Initial Report FDA Received Date: 05/30/2018
• Supplement Report FDA Received Date: 06/26/2018
• 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