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	Pain (1994)
Date of Event	11/29/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Clinical evaluation performed by medical affairs on 13 december 2017: partial hip revision surgery (stem and head) occurred 1 year and 8 months after primary implantation.The patient was complaining about pain.Radiographic image provided shows proximal radiolucent lines that suggest the stem did not find proximal stability, and this might be the cause for pain.The image supplied is of very low quality; a possible bone formation is visible above the greater trochanter, but its relationship with the pain is unknown.Also, the cup is significantly proud from the acetabulum, reason unknown, but there is no evidence that the source of pain can be related.The cup has not been revised.Batch review performed on 14 december 2017.Lot 146966: (b)(4) items manufactured and released on 11 february 2015.Expiration date: 2019-12-31.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.Biolox delta ceramic ball head 12/14 ø 36 size m 0 reference 01.29.209 (k112115) lot 155426: (b)(4) items manufactured and released on 15 december 2015.Expiration date: 2020-11-29 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.
Event or Problem Description
One year and 9 months after primary the surgeon revised the patient for hip pain.Head and stem swapped successfully.

• 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, 6874 ; SZ 6874
• MDR Report Key: 7121383
• Report Number: 3005180920-2017-00749
• Device Sequence Number: 16496742
• Product Code: LZO
• UDI-Device Identifier: 07630030804175
• UDI-Public: 07630030804175
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• PMA/510(K) Number: K093944
• 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): 12/15/2017

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: 12/31/2019
• Device Catalogue Number: 01.18.141
• Device Lot Number: 146966
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/16/2017
• Initial Report FDA Received Date: 12/15/2017
• 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: 76 YR