MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA STEM AMISTEM H CEMENTLESS SIZE 7; HIP STEM CEMENTLESS

Catalog Number	01.18.137
Health Effect - Clinical Code	Inadequate Osseointegration (2646)
Date of Event	01/29/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Batch review performed on (b)(6) 2019: lot 131576: (b)(4) items manufactured and released on 09-jul-2013.Expiration date: 2018-05-31.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been already sold without any similar reported event.Clinical evaluation performed by medical affairs manager: hip revision surgery occurred 5 years after primary cementless total hip arthroplasty in a (b)(6) year old man.Radiographic images provided show the presence of osteolytic regions in gruen zones 1 and 7 and signs of stress-shielding.Aseptic loosening is a possible, literature described adverse event after cementless total hip replacements and causes are often unknown.The reason of this event cannot be determined.
Event or Problem Description
On (b)(6) 2019 we were informed about a revision surgery, planned for (b)(6) 2019, so 5 years and two months after primary surgery, due to stem loosening.

• Brand Name: STEM AMISTEM H CEMENTLESS SIZE 7
• Common Device Name: HIP STEM CEMENTLESS
• Manufacturer (Section D): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, switzerland 6874 ; SZ 6874
• MDR Report Key: 8377331
• Report Number: 3005180920-2019-00101
• Device Sequence Number: 11527214
• Product Code: LZO
• UDI-Device Identifier: 07630030804137
• UDI-Public: 07630030804137
• Combination Product (Y/N): N
• Initial Reporter Country: BE
• PMA/510(K) Number: K093944
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2014
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 02/28/2019

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: 05/31/2018
• Device Catalogue Number: 01.18.137
• Device Lot Number: 131576
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/29/2019
• Initial Report FDA Received Date: 02/28/2019
• 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: 54 YR
• Patient Weight: 85