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

Device Problems Loose or Intermittent Connection (1371); Appropriate Term/Code Not Available (3191)

Patient Problem Insufficient Information (4580)

Event Date 05/02/2022

Event Type  Injury  

Event Description

Revision surgery at 9 years from primary due to stem loosening.Stem revised successfully.

Manufacturer Narrative

No analysis could be performed since lot number is unknown and device is not available for inspection.

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 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
• Type of Device: 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
• MDR Text Key: 292816091
• Report Number: 3005180920-2022-00404
• Device Sequence Number: 1
• Product Code: LZO
• UDI-Device Identifier: 07630030804656
• UDI-Public: 07630030804656
• Combination Product (y/n): N
• Reporter Country Code: BE
• PMA/PMN Number: K121011
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Company Representative
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date: 07/08/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/27/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: 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
• Date Manufacturer Received: 04/29/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/20/2012
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 73 YR
• Patient Sex: Female
• Patient Weight: 79 KG