MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA AMISTEM C CEMENTED STD STEM SIZE 1; CEMENTED HIP STEM

Catalog Number	01.18.151
Health Effect - Clinical Code	No Code Available (3191)
Date of Event	06/21/2015
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Batch review performed on (b)(6) 2018: lot 131188: 25 items manufactured and released on (b)(6) 2013.Expiration date: (b)(6) 2018.No anomalies found related to the issue.To date, all the items of the same lot have been already sold without any similar reported event.
Event or Problem Description
On (b)(6) 2018 the sales representative has been informed by the surgeon that a revision surgery was performed.At this time we do not know if the reason of the revision surgery is bone fracture or stem loosening.
Additional Manufacturer Narrative
Clinical evaluation performed by medical affairs director: revision surgery for loosening of femoral stem in a partial hip arthroplasty performed one year before on an elderly lady, diagnosis unknown, but most likely consequent to proximal femoral fracture.The stem is slightly valgus, the uneven cement mantle is clearly detached from the medial bone, which suggests that during stem insertion conditions could not be kept optimal.The position of the femoral plug is very distal, reason unknown.The resection was performed with an oblique angle and it is rather low: the influence of these parameters on the poor outcome cannot be determined.We cannot see that a defective device caused this adverse event.

• Brand Name: AMISTEM C CEMENTED STD STEM SIZE 1
• Common Device Name: CEMENTED HIP STEM
• Manufacturer (Section D): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, 6874 ; SZ 6874
• MDR Report Key: 7291618
• Report Number: 3005180920-2018-00082
• Device Sequence Number: 18867737
• Product Code: LZO
• UDI-Device Identifier: 07630030804267
• UDI-Public: 07630030804267
• Combination Product (Y/N): N
• Initial Reporter Country: SZ
• PMA/510(K) Number: K103189
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2014
• Device Explanted Year: 2015
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 04/24/2018

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: 04/30/2018
• Device Catalogue Number: 01.18.151
• Device Lot Number: 131188
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 01/24/2018
• Supplement Date Received by Manufacturer: 01/24/2018
• Initial Report FDA Received Date: 02/23/2018
• Supplement Report FDA Received Date: 04/24/2018
• 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: 86 YR