MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA STEM: AMISTEM-H PROX. COAT. AMISTEM-H PROXIMAL COATING STD STEM SIZE 4; CEMENTLESS HIP STEM

Model Number	01.18.174
Health Effect - Clinical Codes	Unspecified Infection (1930); Inadequate Osseointegration (2646)
Date of Event	07/09/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Batch review performed on 20 july 2020: lot 177122: (b)(4) items manufactured and released on 08-feb-2018.Expiration date: 2023-01-31.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.Clinical evaluation performed by medical affairs manager: delayed infection in cementless tha, 2 months after primary operation.Infection is a known possible adverse event following every surgery, including tha's.To date, there is no reason to suspect that the cause may be linked to the implanted devices.Additional implant involved: cup: versafitcup cc trio 01.26.45.1158 acetabular shell cc trio no-hole ø 58 (k122911) lot.174469.Batch review performed on 20 july 2020: lot 174469: (b)(4) items manufactured and released on 08-nov-2017.Expiration date: 2022-10-25.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.Additional implant involved: liner: versafitcup cc trio 01.26.3248hct flat pe hc liner ø 32 / f (k103352) lot.165956.Batch review performed on 20 july 2020: lot 165956: (b)(4) items manufactured and released on 05-dec-2016.Expiration date: 2021-11-15.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.
Event or Problem Description
The hip of the patient was revised on the (b)(6) 2020 (2 months after primary) due to the loosening of the hip stem.Initially, he wanted to change only the stem, but since the surgeon did a puncture and discovered a low-grade infection, he decided also to change the cup and the liner.No more information about the infection agent is available.It is unknown if the loosening is related to the infection.

• Brand Name: STEM: AMISTEM-H PROX. COAT. AMISTEM-H PROXIMAL COATING STD STEM SIZE 4
• Common Device Name: CEMENTLESS HIP STEM
• Manufacturer (Section D): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, 6874 ; SZ 6874
• MDR Report Key: 10354963
• Report Number: 3005180920-2020-00483
• Device Sequence Number: 950916
• Product Code: LZO
• UDI-Device Identifier: 07630030804397
• UDI-Public: 07630030804397
• Combination Product (Y/N): N
• Initial Reporter Country: SZ
• PMA/510(K) Number: K161635
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Device Explanted Year: 2020
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 08/03/2020

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: 01/31/2023
• Device Model Number: 01.18.174
• Device Catalogue Number: 01.18.174
• Device Lot Number: 177122
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/08/2020
• Initial Report FDA Received Date: 08/03/2020
• 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