MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA STEM: AMISTEM C CEMENTED STD STEM SIZE 3; HIP CEMENTED STEM

Model Number	01.18.153
Health Effect - Clinical Code	Joint Disorder (2373)
Date of Event	06/10/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Batch review performed on 08 july 2020: lot 187516: (b)(4) items manufactured and released on 05-dec-2018.Expiration date: 2023-11-21.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.Lot 187517: (b)(4) items manufactured and released on 05-dec-2018.Expiration date: 2023-11-21.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.Clinical evaluation 1.5 years after hybrid tha (acetabular cup is not from medacta) the stem is found loose and replaced.The position of the stem in the pre-revision picture is suboptimal and cementation did not adhere to the bone, perhaps because of insufficient pressurization.We don't know if this condition was already existing after the index surgery as we only have the pre-revision images.The position and orientation of the stem, the undersizing and the poor cementation results are most likely the main causes for this loosening.Preliminary investigation as discussed with the r&d pm n.Pastormerlo it is not possible to establish the root cause based on the pictures.
Event or Problem Description
Revision surgery performed due to stem loosening 1 year and 5 months after the primary.

• Brand Name: STEM: AMISTEM C CEMENTED STD STEM SIZE 3
• Common Device Name: HIP CEMENTED STEM
• Manufacturer (Section D): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, 6874, CHE; CH 6874, CHE
• MDR Report Key: 10257288
• Report Number: 3005180920-2020-00393
• Device Sequence Number: 3083801
• Product Code: LZO
• UDI-Device Identifier: 07630030804281
• UDI-Public: 07630030804281
• Combination Product (Y/N): N
• Initial Reporter Country: SZ
• PMA/510(K) Number: K103189
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Device Explanted Year: 2020
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 07/10/2020

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: No Information
• Device Expiration Date: 11/21/2023
• Device Model Number: 01.18.153
• Device Catalogue Number: 01.18.153
• Device Lot Number: 187516
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/10/2020
• Initial Report FDA Received Date: 07/10/2020
• 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
• Patient Age: 82 YR
• Patient Weight: 75