MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA STEM: AMISTEM H HA COATED LAT STEM SIZE 8; HIP CEMENTLESS STEM

Model Number	01.18.148
Health Effect - Clinical Code	Bone Fracture(s) (1870)
Date of Event	05/17/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Batch review performed on 27 may 2021 lot 102760: (b)(4) items manufactured and released on 21-sep-2010.Expiration date: 2015-08-31.No anomalies found related to the problem.1 item resterilized and released on 24-aug-2012.Expiration date: 2017-06-30.No anomalies found related to the problem.(b)(4) resterilized and released on 13-jun-2015.Expiration date: 2020-04-30.No anomalies found related to the problem.(b)(4) resterilized and released on 06-jul-2015.Expiration date: 2020-05-31.No anomalies found related to the problem.(b)(4) resterilized and released on 05-aug-2015.Expiration date: 2020-05-31.No anomalies found related to the problem.(b)(4) resterilized and released on 24-aug-2015.Expiration date: 2020-07-27.No anomalies found related to the problem.(b)(4) resterilized and released on 23-sep-2015.Expiration date: 2020-08-23.No anomalies found related to the problem.(b)(4) resterilized and released on 18-may-2016.Expiration date: 2021-05-01.No anomalies found related to the problem.To date, (b)(4) of the same lot have been already sold without any other similar reported event since 2017.Clinical evalaution performed by medical affairs director: periprosthetic fracture 2 weeks after primary tha.The patient seems to be overweight and rather old, with very thin cortical bone.On the other hand, the stem looks undersized, and the acetabular cup not well laid on the medial wall, but these conditions are unlikely to have caused the fracture.In any case, we see no reason to suspect a faulty device.
Event or Problem Description
The patient came in 2 weeks after primary following a periprosthetic fracture (unknown cause).The surgeon cabled the fracture and revised successfully stem and head.

• Brand Name: STEM: AMISTEM H HA COATED LAT STEM SIZE 8
• Common Device Name: HIP CEMENTLESS STEM
• Manufacturer (Section D): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, 6874 ; SZ 6874
• MDR Report Key: 12015240
• Report Number: 3005180920-2021-00491
• Device Sequence Number: 4543690
• Product Code: LZO
• UDI-Device Identifier: 07630030804243
• UDI-Public: 07630030804243
• Combination Product (Y/N): N
• Initial Reporter Country: IS
• PMA/510(K) Number: K093944
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Device Explanted Year: 2021
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 06/17/2021

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: 05/18/2016
• Device Model Number: 01.18.148
• Device Catalogue Number: 01.18.148
• Device Lot Number: 102760
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/18/2021
• Initial Report FDA Received Date: 06/17/2021
• 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: 83 YR
• Patient Weight: 90