MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA STEM: AMISTEM H HA COATED LAT STEM SIZE 2; CEMENTLESS HIP STEM

Catalog Number	01.18.142
Health Effect - Clinical Code	Inadequate Osseointegration (2646)
Date of Event	03/19/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Batch review performed on 12 april 2019: lot 115308: (b)(4) items manufactured and released on 09-mar-2012.Expiration date: 2017-01-31.No anomalies found related to the problem.To date, all the items of this lot have already been sold, without any other similar event reported.Clinical evaluation performed by medical affairs manager: partial hip revision surgery (stem and head) occurred 6.5 years after cementless total hip arthroplasty in a (b)(6) year old man.Radiographic image provided does not allow a proper clinical evaluation, and no other useful information is available.We cannot determine the cause for this adverse event.
Event or Problem Description
On (b)(6) 2019 we were informed about a revision performed on the next day, 6 years and 4 months after primary, due to stem loosening.Stem and ceramic head revised successfully.
Additional Manufacturer Narrative
On the contrary to what initially reported in the initial report, the explant became available and was received on (b)(6) 2019.Visual inspection performed by r&d project manager: ha layer still intact on the proximal part of the stem.The visual inspection is in line with the revision motivation.

• Brand Name: STEM: AMISTEM H HA COATED LAT STEM SIZE 2
• Common Device Name: CEMENTLESS HIP STEM
• Manufacturer (Section D): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, switzerland 6874 ; SZ 6874
• MDR Report Key: 8522866
• Report Number: 3005180920-2019-00280
• Device Sequence Number: 16833963
• Product Code: LZO
• UDI-Device Identifier: 07630030804182
• UDI-Public: 07630030804182
• Combination Product (Y/N): N
• Initial Reporter Country: SZ
• PMA/510(K) Number: K093944
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2012
• Device Explanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 05/27/2019

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: 01/31/2017
• Device Catalogue Number: 01.18.142
• Device Lot Number: 115308
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/29/2019
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/18/2019
• Supplement Date Received by Manufacturer: 03/18/2019
• Initial Report FDA Received Date: 04/17/2019
• Supplement Report FDA Received Date: 05/27/2019
• 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: 65 YR
• Patient Weight: 92