MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA STEM: AMISTEM H HA COATED LAT STEM SIZE 4; CEMENTLESS STEM

Catalog Number	01.18.144
Health Effect - Clinical Code	Unspecified Infection (1930)
Date of Event	09/05/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Batch review performed on (b)(6) 2019: lot 162260: 57 items manufactured and released on 26-jul-2016.Expiration date: 2021-07-04.No anomalies found related to the problem.To date, 45 items of the same lot have been already sold without any similar reported event.Additional implants involved in the event, batch review performed on (b)(6) 2019: cup: versafitcup cc trio 01.26.45.1152 acetabular shell cc trio no-hole ø 52 (k122911) lot.164420.Lot 164420: 140 items manufactured and released on 24-oct-2016.Expiration date: 2021-10-09.No anomalies found related to the problem.To date, 140 items of the same lot have been already sold without any similar reported event.Liner: cc e cc light 01.26.3244 hct flat pe hc liner ø 32 / e (k103352) lot.163954 lot 163954: 130 items manufactured and released on 22-sept-2016.Expiration date: 2021-09-07.No anomalies found related to the problem.To date, 130 items of the same lot have been already sold without any similar reported event.Implants from ceramtec 38.49.7175.665.00 biolox delta ceramic ball head 12/14 ø 32 size s -4 lot.7011090857 (item not registered in usa).The component properties and the microstructure as obtained from the quality documents fulfill the requirements as specified at the time of production.There are no indications of any pre-existing material defect or non-conformities regarding sterilisation.Due to a lack of ceramic parts further investigations cannot be done.
Event or Problem Description
On the (b)(6) 2019 we were informed of a revision surgery planned and performed on the (b)(6) 2019, about 2 years and 9 months after primary for infection and stem subsidence.The surgery was completed successfully.The pathogen is multi-resistent skin germ.

• Brand Name: STEM: AMISTEM H HA COATED LAT STEM SIZE 4
• Common Device Name: CEMENTLESS STEM
• Manufacturer (Section D): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, 6874 ; SZ 6874
• MDR Report Key: 9096668
• Report Number: 3005180920-2019-00785
• Device Sequence Number: 2592059
• Product Code: LZO
• UDI-Device Identifier: 07630030804205
• UDI-Public: 07630030804205
• Combination Product (Y/N): N
• Initial Reporter Country: SZ
• PMA/510(K) Number: K093944
• 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): 09/20/2019

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: 07/04/2021
• Device Catalogue Number: 01.18.144
• Device Lot Number: 162260
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/22/2019
• Initial Report FDA Received Date: 09/20/2019
• 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