MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA STEM: AMISTEM H HA COATED LAT STEM SIZE 2; CEMENTLESS STEM

Catalog Number	01.18.142
Health Effect - Clinical Code	Pain (1994)
Date of Event	12/14/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Batch review performed on 18 september 2019: lot 152218: 123 items manufactured and released on 16-jul-2015.Expiration date: 2020-06-30.No anomalies found related to the problem.To date, 115 the items of the same lot have been sold without any similar reported event.Clinical evaluation performed by medical affairs director: few months after primary cementless tha, the patient reports pain and the stem is revised.We have very limited information, but the single image provided displays a very anomalous bone condition, whose origin is totally unknown to us but it cannot be considered alien to the early loss of fixation.Though we are not informed of the general health status of this patient, the probability that the general condition determined this loosening is extremely high, based on our experience.Additional implants involved in the event, batch review performed on 18 september 2019: ball heads: cocr 01.25.123 cocr ball head 12/14 ø 22 size m 0 (k080885) lot.142883 lot 142883: 19 items manufactured and released on 16-jul-2014.Expiration date: 2019-06-30.No anomalies found related to the problem.To date, 11 the items of the same lot have been sold without any similar reported event.Liner: versafitcup dm 01.26.2246mhc double mobility hc liner ø 46/22.2 (k092265) lot.183111 lot 183111: 24 items manufactured and released on 10-jul-2018.Expiration date: 2023-06-20.No anomalies found related to the problem.To date, 13 the items of the same lot have been sold without any similar reported event.
Event or Problem Description
Revision surgery performed 10 months after the primary due to pain and the cause of the pain is unknown.The surgeon revised the stem, liner and head successfully.The implants looked well fixed, the cause of the pain couldn't be identified.

• Brand Name: STEM: AMISTEM H HA COATED LAT STEM SIZE 2
• Common Device Name: CEMENTLESS STEM
• Manufacturer (Section D): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, 6874 ; SZ 6874
• MDR Report Key: 9155333
• Report Number: 3005180920-2019-00840
• Device Sequence Number: 2599459
• Product Code: LZO
• UDI-Device Identifier: 07630030804182
• UDI-Public: 07630030804182
• 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: 2018
• Device Explanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 10/04/2019

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: 06/30/2020
• Device Catalogue Number: 01.18.142
• Device Lot Number: 152218
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/06/2019
• Initial Report FDA Received Date: 10/04/2019
• 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