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

Catalog Number	01.18.174
Health Effect - Clinical Code	Inadequate Osseointegration (2646)
Date of Event	07/03/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Batch review performed on 10 july 2019: lot 182815: (b)(4) items manufactured and released on 04-july-2018.Expiration date: 2023-06-20.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 devices involved: batch review performed on 10 july 2019: cup: versafitcup cc trio 01.26.45.1158 acetabular shell cc trio no-hole ø 58 (k122911) lot 181710: (b)(4) items manufactured and released on 22-may-2018.Expiration date: 2023-05-07.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.Preliminary investigation performed by medacta r&d hip project manager: from the received images, no particular signs were noticed that could relate to the event.Analyzing the x-ray images, accordingly to the medical direction, the positioning of the stem and the cup, protruding from the related seats, could be a cause related to the event; from the received information the event cannot be related to a defective device.Clinical evaluation performed by medacta medical affairs director: few months after primary cementless tha a revision is required for loosening.The anatomy of the patient probably drove the femoral resection level to be extremely low and in these conditions the stem is subject to an extreme challenge to withstand rotational loads.Probably for the same reason, and to preserve correct leg length, the cup has been implanted too proud from the acetabulum and could not offer sufficient stability.The cause for this revision is not defective devices.
Event or Problem Description
On the (b)(4) 2019 we were informed of a revision surgery performed on the (b)(6) 2019, about 4 months and a half from the primary for stem loosening and cup malpositioning.Femur stress shielding was detected.The surgery was completed successfully.

• Brand Name: STEM: AMISTEM-H PROX. COAT. STD STEM SIZE 4
• Common Device Name: UNCEMENTED HIP STEM
• Manufacturer (Section D): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, 6874 ; SZ 6874
• MDR Report Key: 8840207
• Report Number: 3005180920-2019-00628
• Device Sequence Number: 259713
• 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: 2019
• 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): 07/30/2019

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: 06/20/2023
• Device Catalogue Number: 01.18.174
• Device Lot Number: 182815
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/02/2019
• Initial Report FDA Received Date: 07/30/2019
• 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: 49 YR
• Patient Weight: 102