MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA VERSAFITCUP CC TRIO ACETABULAR SHELL CC TRIO NO-HOLE Ø 52; SCETABULAR SHELL

Catalog Number	01.26.45.1152
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	06/20/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Batch review performed on 17 july 2018: lot 174465: (b)(4) items manufactured and released on 02 november 2017.Expiration date: 2022-10-23 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.Visual inspection performed by washing and packaging manager on 16 july 2018 from the picture it is possible notice the presence of a hair.The hair is between the mousse and the tyvek, due to the position it is not possible see it during the double check performed during external packaging phase.It is possible that during the packaging phase in cleanroom, a hair fell into the packaging.After the manufacturing of this lot, new equipment as new cleanroom suit were introduced and new cleaning method were introduced in order to prevent this kind of contamination.However, the packaging was received opened from the hospital, so it is not possible to be 100% sure that the event occurred during packaging process.
Event or Problem Description
Before the sterile cup was opened, the medical staff found a hair inside the blister.The operation was carried out with the same cup size, different lot.

• Brand Name: VERSAFITCUP CC TRIO ACETABULAR SHELL CC TRIO NO-HOLE Ø 52
• Common Device Name: SCETABULAR SHELL
• Manufacturer (Section D): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, switzerland 6874 ; SZ 6874
• MDR Report Key: 7706374
• Report Number: 3005180920-2018-00520
• Device Sequence Number: 996224
• Product Code: LZO
• UDI-Device Identifier: 07630030807893
• UDI-Public: 07630030807893
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: K122911
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 07/20/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 10/23/2022
• Device Catalogue Number: 01.26.45.1152
• Device Lot Number: 174465
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/27/2018
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/20/2018
• Initial Report FDA Received Date: 07/20/2018
• 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: Other
• Patient Age: 72 YR
• Patient Weight: 65