MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA AMISTEM H HA COATED LAT STEM SIZE 1; CEMENTLESS HIP STEM

Catalog Number	01.18.141
Health Effect - Clinical Code	Osteolysis (2377)
Date of Event	05/14/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Batch review performed on 12 june 2018.Lot 123317:20 items manufactured and released on (b)(6) 2012 expiration date: 2017-10-31, no anomalies found related to the problem.To date, 17 items of the same lot have been already sold without any similar reported event.Clinical evaluation performed by medical affairs manager on (b)(6) 2018 partial hip revision surgery occurred 4 years after primary cementless total hip arthroplasty.Bone formation on the distal part of the stem is visible but radiographic image provided doesn't allow a proper clinical evaluation due to low quality.No conclusion can be drawn on the basis of information received.Visual inspection performed by r&d product manager on (b)(6) 2018 hip stem shows residual hydroxyapatite on the proximal stem, indicating non-complete resorption of the ha layer in that area.X-ray images provided do not allow a valid analysis of the stem positioning before revision.The acetabular insert shows normal signs of wear in phase on the articulating surface, slightly burnished as result of few years of in situ time, with no particular signs of scratches.Femoral head shows slight metal transfer scratching due to extraction process.Femoral neck shows sign of deep scratching due to stem extraction process.
Event or Problem Description
About 4 years after primary the surgeon revised the patient right hip for osteolysis.The surgery was completed successfully.
Additional Manufacturer Narrative
On 07 august 2018 the sales representative reported the stem was not mobilized as it was well fixed distally.

• Brand Name: AMISTEM H HA COATED LAT STEM SIZE 1
• Common Device Name: CEMENTLESS HIP STEM
• Manufacturer (Section D): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, switzerland 6874 ; SZ 6874
• MDR Report Key: 7596015
• Report Number: 3005180920-2018-00415
• Device Sequence Number: 10807778
• Product Code: LZO
• UDI-Device Identifier: 07630030804175
• UDI-Public: 07630030804175
• 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: 2014
• Device Explanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 09/06/2018

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: 10/31/2017
• Device Catalogue Number: 01.18.141
• Device Lot Number: 123317
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/30/2018
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/14/2018
• Supplement Date Received by Manufacturer: 05/14/2018
• Initial Report FDA Received Date: 06/13/2018
• Supplement Report FDA Received Date: 09/06/2018
• 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