MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA STEM: AMISTEM-H PROX. COAT. AMISTEM-H PROXIMAL COATING STD STEM SIZE 3; CEMENTLESS HIP STEM

Catalog Number	01.18.173
Health Effect - Clinical Code	Unspecified Infection (1930)
Date of Event	10/08/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Batch review performed on 14 october 2019: lot 180055: (b)(4) items manufactured and released on 9-may-2018.Expiration date: 2023-05-01.No anomalies found related to the problem.To date, all items of the same lot have been already sold without any other similar reported event.Additional implant involved: cup: versafitcup cc trio 01.26.45.1154 acetabular shell cc trio no-hole 54 (k122911) lot.172515.Batch review performed on 14 october 2019: lot 172515: (b)(4) items manufactured and released on 12-sep-2018.Expiration date: 2022-09-03.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been already sold without any other similar reported event.Additional implant involved: liner: cc e cc light 01.26.2844hct flat pe hc liner 28 / e (k103352) lot.176979.Batch review performed on 14 october 2019: lot 176979: (b)(4) items manufactured and released on 6-mar-2018.Expiration date: 2023-02-15.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been already sold without any other similar reported event.Additional implant involved: implants from ceramtec 38.49.7175.465.00 biolox delta ceramic ball head 12/14 28 size l +3.5 lot.7010905183 (not distributed in the usa).Document review performed by the supplier ceramtec for the ceramic ball head implant: due to lack of information about the lase r engraving the identification of the ball head is only possible based on the information provided by medacta.The ball head belongs to the shop order (b)(4).Protocols and certificate of conformance were reviewed.The quality documents ( including the sterilization certificates) show that the values obtained on the ball head were according to the specification valid at the time of production.The component properties and 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 sterilization.Due to a lack of ceramic parts further investigations cannot be done.Clinical evaluation performed by medical affairs manager delayed infection in cementless tha, 1.4 years 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.
Event or Problem Description
Revision surgery performed 1 year and 4 months after the primary due to infection and observed subcutan swelling.The kind of pathogen is unknown.All implants have been removed, pathogen is being analyzed.No reimplantation at the moment.

• Brand Name: STEM: AMISTEM-H PROX. COAT. AMISTEM-H PROXIMAL COATING STD STEM SIZE 3
• Common Device Name: CEMENTLESS HIP STEM
• Manufacturer (Section D): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, 6874 ; SZ 6874
• MDR Report Key: 9284521
• Report Number: 3005180920-2019-00930
• Device Sequence Number: 19333690
• Product Code: LZO
• UDI-Device Identifier: 07630030804380
• UDI-Public: 07630030804380
• 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: 2018
• 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): 11/06/2019

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: 05/01/2023
• Device Catalogue Number: 01.18.173
• Device Lot Number: 180055
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/07/2019
• Initial Report FDA Received Date: 11/06/2019
• 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
• Patient Age: 72 YR
• Patient Weight: 97