MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA LINER: VERSAFITCUP CC TRIO FLAT PE HC LINER 36 / F

Model Number	01.26.3648HCT
Health Effect - Clinical Code	Pain (1994)
Date of Event	07/27/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Batch review performed by medacta regulatory affairs department on 07.08.2020: lot 147158: (b)(4) items manufactured and released on 14-jan-2015.Expiration date: 2019-nov-30.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been already sold without any other similar reported event since 2016.Clinical evaluation performed by medical affairs director: 5 years after primary cementless tha the patient has pain and a head-inlay exchange is performed, after verifying that the stem is well fixed.The stem position appears to be rather distal, as if it had subsided a little, and a rarefied bone density area is visible in gruen zone 5, but since we have no history of this case we cannot judge the relevance of these observations.The cause for this pain and need for reoperation remains undetermined, but there is no hint that it can be due to a defective device.Additional item involved in the event: implants from ceramtec 38.49.7175.925.00 biolox delta ceramic ball head 12/14 ø 36 size xl +8 lot.802014 (item not registered in usa).
Event or Problem Description
Amis revision surgery performed after 4 years and 9 months due to pain.The surgeon removed the head and inlay, after that he hit the stem a few times with an pestle to look if the stem is loosened.The stem was not loosened.The surgeon implanted a new inlay liner f 32mm and an 32mm xxl cocr head.

• Brand Name: LINER: VERSAFITCUP CC TRIO FLAT PE HC LINER 36 / F
• Common Device Name: PE HC LINER
• Manufacturer (Section D): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, 6874 ; SZ 6874
• MDR Report Key: 10447984
• Report Number: 3005180920-2020-00539
• Device Sequence Number: 19904374
• Product Code: LZO
• UDI-Device Identifier: 07630030807688
• UDI-Public: 07630030807688
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: K103352
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2015
• Device Explanted Year: 2020
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 08/25/2020

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: 11/30/2019
• Device Model Number: 01.26.3648HCT
• Device Catalogue Number: 01.26.3648HCT
• Device Lot Number: 147158
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/27/2020
• Initial Report FDA Received Date: 08/25/2020
• 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