MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA AMISTEM-H PROXIMAL COATING STEM SIZE 1 STD; CEMENTLESS FEMORAL STEM

Catalog Number	01.18.171
Health Effect - Clinical Codes	Pain (1994); Joint Disorder (2373)
Date of Event	05/24/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Batch review performed on 25 july 2017.Lot 164515: (b)(4) items manufactured and released on 22 september 2016.Expiration date: 2021-09-12.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.On (b)(6) 2017 the medical affairs director performed a clinical evaluation and commented as follows: stem revision in cementless tha after 5 months.The pre-revision x-rays show a stem that achieved no osseointegration, radiographically loose.The report mentions a very high and early activity level of the patient, which might be a cause; such a thorough detachment of the stem from the bone could also be the result of an acute inflammatory process, although we presume, given the high degree of specialization of the treating center, that causes such as infection have been checked and ruled out.The cause of this revision cannot be determined with certainty with the information at hand.
Event or Problem Description
Revision surgery, two months after primary surgery, due to pain and loosening.

• Brand Name: AMISTEM-H PROXIMAL COATING STEM SIZE 1 STD
• Common Device Name: CEMENTLESS FEMORAL STEM
• Manufacturer (Section D): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, 6874 ; SZ 6874
• MDR Report Key: 6746478
• Report Number: 3005180920-2017-00413
• Device Sequence Number: 16189940
• Product Code: LZO
• UDI-Device Identifier: 07630030804366
• UDI-Public: 07630030804366
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: K161635
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2016
• Device Explanted Year: 2017
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 07/27/2017

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: 09/12/2021
• Device Catalogue Number: 01.18.171
• Device Lot Number: 164515
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 06/29/2017
• Initial Report FDA Received Date: 07/27/2017
• 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: 64 YR