MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA CUP: VERSAFITCUP CC TRIO ACETABULAR SHELL CC TRIO Ø 50; ACETABULAR CUP

Catalog Number	01.26.45.0050
Medical Device Problem Code	Loosening of Implant Not Related to Bone-Ingrowth (4002)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	12/05/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Batch review performed on 10 december 2019.Lot 157648: 100 items manufactured and released on 24-mar-2016.Expiration date: 2021-03-10.No anomalies found related to the problem.To date, 88 items of the same lot have been already sold without any similar reported event.Preliminary investigation performed by r&d project manager.Shell covered in biological fluids, signs of extraction on pe liner.It is not possible to determine failure root cause.Clinical evaluation performed by medical affairs manager.Partial hip revision surgery (head, cup and liner) performed 3 years and 7 months after cementless total hip arthroplasty in an elderly woman ((b)(6)).Cup mobilization is visible in the image provided but no additional evaluation can be done due to low quality.The surgeon suspects the presence of a cyst or bone defect that cannot be confirmed on the basis of available information.The reason of this event cannot be determined.
Event or Problem Description
Revision surgery performed, 3 years and 7 months after primary surgery, due to cup loosening.Anterior approach used during the revision.Also the head, liner and the screws have been removed.The surgeon suspects the patient had a cyst or bone defect that collapsed causing the implant to move.

• Brand Name: CUP: VERSAFITCUP CC TRIO ACETABULAR SHELL CC TRIO Ø 50
• Common Device Name: ACETABULAR CUP
• Manufacturer (Section D): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, 6874 ; SZ 6874
• MDR Report Key: 9510715
• Report Number: 3005180920-2019-01105
• Device Sequence Number: 209563
• Product Code: LZO
• UDI-Device Identifier: 07630030807763
• UDI-Public: 07630030807763
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K103352
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2016
• Device Explanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 12/23/2019

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: 03/10/2021
• Device Catalogue Number: 01.26.45.0050
• Device Lot Number: 157648
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/05/2019
• Initial Report FDA Received Date: 12/23/2019
• 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
• Patient Age: 85 YR
• Patient Weight: 90