MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA AMISTEM H HA COATED STD STEM SIZE 1; HIP UNCEMENTED STEM

Model Number	01.18.131
Health Effect - Clinical Code	Unspecified Infection (1930)
Date of Event	07/13/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Batch review performed on 20 july 2022: lot 131567: 60 items manufactured and released on 01-jul-13.Expiration date: 2018-may-31.No anomalies found related to the problem.To date, all items of the same lot have been sold with no similar reported event during the period of review.Additional devices involved: batch reviews performed on 20 july 2022.Ball heads: mectacer 01.29.203 biolox delta ceramic ball head 12/14 ø 28 size l +3.5 (k112115) lot 131047: 40 items manufactured and released on 22-may-2013.Expiration date: 2018-apr-30.No anomalies found related to the problem.To date, 37 items of the same lot have been sold with no similar reported event during the period of review.Liner: versafitcup dm 01.26.2852mhc double mobility hc liner ø 52/28 (k092265) lot 131719: 40 items manufactured and released on 15-may-2013.Expiration date: 2018-mar-31.No anomalies found related to the problem.To date, 39 items of the same lot have been sold with no similar reported event during the period of review.Cup: versafitcup 01.26.52mb acetabular shell cc ø 52 (k083116) lot 131688: 55 items manufactured and released on 15-may-2013.Expiration date: 2018-mar-31.No anomalies found related to the problem.To date, 54 items of the same lot have been sold with no similar reported event during the period of review.
Event or Problem Description
The patient came in due to signs of an infection and the pathogen is unknown.About 8 years and 10 months after the primary surgery, the surgeon performed a washout, removed all implants, and implanted an antibiotic spacer.The surgery was completed successfully.

• Brand Name: AMISTEM H HA COATED STD STEM SIZE 1
• Common Device Name: HIP UNCEMENTED STEM
• Manufacturer (Section D): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, 6874 ; SZ 6874
• Manufacturer (Section G): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, 6874 ; SZ 6874
• Manufacturer Contact: stefano baj ; strada regina; castel san pietro, switzerland 6874 ; SZ 6874
• MDR Report Key: 15154905
• Report Number: 3005180920-2022-00598
• Device Sequence Number: 5323811
• Product Code: LZO
• UDI-Device Identifier: 07630030804076
• UDI-Public: 07630030804076
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• PMA/510(K) Number: K093944
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2013
• Device Explanted Year: 2022
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 03/08/2022

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: 05/31/2018
• Device Model Number: 01.18.131
• Device Catalogue Number: 01.18.131
• Device Lot Number: 131567
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/13/2022
• Initial Report FDA Received Date: 08/03/2022
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 07/01/2013
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Female