MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA AMISTEM H, HA COATED STEM SIZE 7 STD; CEMENTLESS FEMORAL STEM

Catalog Number	01.18.137
Health Effect - Clinical Code	Joint Disorder (2373)
Date of Event	09/15/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
On 06 october 2017 the medical affairs director performed a clinical evaluation and commented as follows: partial hip revision surgery (stem and head) occurred 7 years after primary total hip arthroplasty.According to the report, the reason for revision is stem aseptic loosening.The poor quality radiographic image provided doesn't allow an adequate clinical evaluation.Aseptic loosening is a possible, literature described mid-term adverse event following cementless tha and causes are often unknown.On the basis of available information, the reason of this event cannot be determined batch review performed on 17 october 2017.Lot 093017: (b)(4) items manufactured and released on 09 may 2010.Expiration date: 2015-01-31.No anomalies found related to the problem.To date, (b)(4) stems of this lot have been already sold and this is the second similar issue reported on the lot.On 19 october 2017 the r&d project manager performed a visual inspection of the retrieved items and commented as follows: the stem was analyzed: it was visible a surface without ha remained and the presence of fibrotic tissue on the body in the metaphyseal area.Moreover, great signs of removal were visible in the intradox and on the taper, the last ones occurred by the use of the stem extractor.Also signs on the neck were present.In the ceramic ball head there were a big sign, probably occurred during the extraction.All these signs show a demanding revision phase, apparently showing a good anchorage of the implant into the femur.From the received pieces it was not possible to determine the root cause of the event.
Event or Problem Description
Seven years after primary the surgeon detected stem loosening and revised the patient swapping successfully the stem and the liner.

• Brand Name: AMISTEM H, HA COATED STEM SIZE 7 STD
• Common Device Name: CEMENTLESS FEMORAL STEM
• Manufacturer (Section D): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, 6874 ; SZ 6874
• MDR Report Key: 6964491
• Report Number: 3005180920-2017-00595
• Device Sequence Number: 11087017
• Product Code: LZO
• UDI-Device Identifier: 07630030804137
• UDI-Public: 07630030804137
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: K093944
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2010
• Device Explanted Year: 2017
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 10/20/2017

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: 01/31/2015
• Device Catalogue Number: 01.18.137
• Device Lot Number: 093017
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/18/2017
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 09/20/2017
• Initial Report FDA Received Date: 10/20/2017
• 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: 63 YR