MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA STEM: AMISTEM H 01.18.240 STEM COLLARED HA COATED LAT STEM SIZE 0; HIP STEM

Model Number	01.18.240
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	05/02/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
Revision surgery at 9 years from primary due to stem loosening.Stem revised successfully.
Additional Manufacturer Narrative
No analysis could be performed since lot number is unknown and device is not available for inspection.
Additional Manufacturer Narrative
Batch review performed on 22 june 2022: lot 115660: (b)(4) items manufactured and released on 20-feb-2012.Expiration date: 2017-01-31.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been sold without any similar reported event during the period of review.Visual inspection performed by r&d project manager: during the visual inspection it has been noticed that the ha coating body has been absorbed at the proximal aspect of the stem as expected, instead there is still some ha coated area in the distal aspect.It seems that the stem was not completely osteointegrated with the patient bone.Some signs and scratches are present on the stem neck probably due to revision surgery.It is not possible to determine the root cause of reported loosening.
Event or Problem Description
Revision surgery at 7 years and 10 mnths from primary due to stem loosening.Stem revised successfully.

• Brand Name: STEM: AMISTEM H 01.18.240 STEM COLLARED HA COATED LAT STEM SIZE 0
• Common Device Name: HIP STEM
• Manufacturer (Section D): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, 6874 ; SZ 6874
• Manufacturer (Section G): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, 6874 ; SZ 6874
• Manufacturer Contact: stefano baj ; strada regina; castel san pietro, switzerland 6874 ; SZ 6874
• MDR Report Key: 14522264
• Report Number: 3005180920-2022-00404
• Device Sequence Number: 6466204
• Product Code: LZO
• UDI-Device Identifier: 07630030804656
• UDI-Public: 07630030804656
• Combination Product (Y/N): N
• Initial Reporter Country: BE
• PMA/510(K) Number: K121011
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2014
• Device Explanted Year: 2022
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 07/08/2022

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: 01/31/2017
• Device Model Number: 01.18.240
• Device Catalogue Number: 01.18.240
• Device Lot Number: 115660
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/29/2022
• Supplement Date Received by Manufacturer: 04/29/2022
• Initial Report FDA Received Date: 05/27/2022
• Supplement Report FDA Received Date: 07/08/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/20/2012
• 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 Age: 73 YR
• Patient Sex: Female
• Patient Weight: 79 KG