MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA AMISTEM-P COLLARED STD STEM SIZE 8; HIP CEMENTLESS STEM

Model Number	01.29.210
Medical Device Problem Code	Device Appears to Trigger Rejection (1524)
Health Effect - Clinical Code	Unspecified Infection (1930)
Date of Event	08/17/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
At about 2 years and 8 months after the primary surgery, the patient came in due to signs of an infection and the pathogen is unknown.The surgeon performed a washout and revised the head and liner.The surgery was completed successfully.
Additional Manufacturer Narrative
Batch review performed on 24-aug-2022: lot 1904653: (b)(4) items manufactured and released on 25-sep-2019.Expiration date: 2024-09-08.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been sold with no similar reported case during the period of review.Additional device involved batch review performed on 24-aug-2022: liner: mpact 01.32.3652hct flat pe hc liner ø36/g (k103721) lot 1900223: (b)(4) items manufactured and released on 16-apr-2019.Expiration date: 2024-04-02.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been sold with no similar reported case during the period of review.
Event or Problem Description
The patient had a primary hip surgery on (b)(6) 2019.On (b)(6) 2022, the patient came in reporting pain due to a dislocation of the head from the liner and the cause is unknown.The surgeon revised successfully the head and liner.On (b)(6) 2022, the patient came in due to signs of an infection and the pathogen was unknown.The surgeon performed a washout and revised head, sleeve, liner, cup and stem.The surgery was completed successfully.
Additional Manufacturer Narrative
The patient had a primary hip surgery on (b)(6) 2019.On (b)(6) 2022, the patient came in reporting pain due to a dislocation of the head from the liner and the cause is unknown.The surgeon revised successfully the head and liner.On (b)(6) 2022, the patient came in due to signs of an infection and the pathogen was unknown.The surgeon performed a washout and revised head, sleeve, liner, cup and stem.The surgery was completed successfully.The patient primary surgery date is (b)(6) 2019.These are the revised product: batch review performed on 03-may-2023: lot 1900091: (b)(4) items manufactured and released on 02-may-2019.Expiration date: 2024-04-16.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been sold with no similar reported case during the period of review.Additional devices involved batch reviews performed on 03-may-2023: liner: impact 01.32.4052hc10a face-changing 10° pe hc liner ø40/g (k183582) lot 1810856: (b)(4) items manufactured and released on 04-apr-2019.Expiration date: 2024-03-19.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been sold with another similar reported case during the period of review.Ball heads: mectacer 01.29.233h head biolox option ø 40 (k131518) lot 2115395: (b)(4) items manufactured and released on 02-feb-2022.Expiration date: 2027-01-24.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been sold with no similar reported case during the period of review.Cup: mpact 01.32.162dh acetabular shell ø62 two-holes (k132879) lot 178265: (b)(4) items manufactured and released on 20-mar-2018.Expiration date: 2023-03-09.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been sold with no similar reported case during the period of review.Ball heads: mectacer 01.29.242a sleeve size l (k131518) lot 22c0012: (b)(4) items manufactured and released on 08-mar-2022.Expiration date: 2027-02-15.No anomalies found related to the problem.To date, all items of the same lot have been sold with no similar reported case during the period of review.

• Brand Name: AMISTEM-P COLLARED STD STEM SIZE 8
• Common Device Name: HIP CEMENTLESS STEM
• Manufacturer (Section D): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, switzerland 6874 ; SZ 6874
• Manufacturer (Section G): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, switzerland 6874 ; SZ 6874
• Manufacturer Contact: stefano baj ; strada regina; castel san pietro, switzerland 6874 ; SZ 6874
• MDR Report Key: 15400680
• Report Number: 3005180920-2022-00696
• Device Sequence Number: 6178988
• Product Code: LZO
• UDI-Device Identifier: 07630040720274
• UDI-Public: 07630040720274
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• PMA/510(K) Number: K173794
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Device Explanted Year: 2022
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 05/04/2023

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: 04/16/2016
• Device Model Number: 01.29.210
• Device Catalogue Number: 01.18.438
• Device Lot Number: 1900091
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/17/2022
• Supplement Date Received by Manufacturer: 08/17/2022
• Initial Report FDA Received Date: 09/12/2022
• Supplement Report FDA Received Date: 05/04/2023
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 05/02/2019
• 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: Male