MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA MPACT ACETABULAR SHELL Ø58 MULTI-HOLE; ACETABULA SHELL

Catalog Number	01.32.158MH
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	06/05/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Batch review performed on 02 july 2018.Lot 145866: (b)(4) items manufactured and released on 17 april 2015.Expiration date: 29.02.2020.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.No additional reports have been received regarding this lot and the feedback history does not indicate there to be a systemic deficiency of the device.Visual inspection performed by r&d product manager on 02 july 2018.Analyzing impact 01.32.158mh acetabular shell d.58 multi hole lot.145866, we have noticed some particles of coating into the packaging.From the analyzed piece it is not possible to determine the root cause of the event.On (b)(6) 2018 the coating supplier was informed about the issue.On (b)(6) 2018 they reported that the subject device was coated using a manual machine coating process and then it was treated in order to remove irregularities in the coating.The manual machine has been replaced by an automatic machine coating process.The manual machine coating process may have resulted in coating peaks that were subject to detachment if abraded.
Event or Problem Description
The nurse found some coating pieces in the cup inner packaging.The surgeon used a back-up implant to complete the surgery.

• Brand Name: MPACT ACETABULAR SHELL Ø58 MULTI-HOLE
• Common Device Name: ACETABULA SHELL
• Manufacturer (Section D): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, switzerland 6874 ; SZ 6874
• MDR Report Key: 7662369
• Report Number: 3005180920-2018-00480
• Device Sequence Number: 16404142
• Product Code: LPH
• UDI-Device Identifier: 07630030810909
• UDI-Public: 07630030810909
• Combination Product (Y/N): N
• PMA/510(K) Number: K132879
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 07/04/2018

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: 02/29/2020
• Device Catalogue Number: 01.32.158MH
• Device Lot Number: 145866
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/21/2018
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/05/2018
• Initial Report FDA Received Date: 07/04/2018
• 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