MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA AMISTEM H, HA COATED STEM SIZE 1 STD; CEMENTLESS FEMORAL STEM

Catalog Number 01.18.131

Device Problem Failure To Adhere Or Bond (1031)

Patient Problem Joint Disorder (2373)

Event Type  Injury  

Manufacturer Narrative

On 18 august 2017 the medical affairs director performed a clinical evaluation and commented as follows: partial revision (femoral stem) in cementless double mobility tha on a young lady after two years.The stem appears to be loose on the supplied radiographs.Some sclerotic lines are also visible around the cup, which has not been revised though.The stem appears to have a rather significant anteversion but this cannot be assumed to be the cause for loosening.Aseptic loosening is a possible adverse event following tha and very often, like in this case, the main cause remains unknown.Batch reviews performed on 21 august 2017.Lot 150841: (b)(4) items manufactured and released on 26 may 2015.Expiration date: 2020-04-30.No anomalies found related to the reported issue.To date, (b)(4) items of the same lot have been already sold without any similar reported event.Mectacer biolox delta ceramic ball head 12/14 ø 28 size l +3.5, code 01.29.203, lot.148656 (k112115).(b)(4) items manufactured and released on 17 march 2015.Expiration date: 2020-02-29.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.Versafitcup double mobility hc liner ø 48/28, code 01.26.2848mhc, lot.151096 (k092265) (b)(4) items manufactured and released on 07 july 2015.Expiration date: 2020-05-31.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.

Event Description

The patient came in complaining of laxity.The cause of laxity is unknown.The surgeon revised the stem, head, and liner.The surgery was completed successfully.X-rays are available.Explants will not become available.

• Brand Name: AMISTEM H, HA COATED STEM SIZE 1 STD
• Type of Device: CEMENTLESS FEMORAL STEM
• Manufacturer (Section D): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, 6874 ; SZ 6874
• Manufacturer (Section G): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, 6874 ; SZ 6874
• Manufacturer Contact: stefano baj ; strada regina; castel san pietro, 6874 ; SZ 6874
• MDR Report Key: 6812710
• MDR Text Key: 83366427
• Report Number: 3005180920-2017-00462
• Device Sequence Number: 1
• Product Code: LZO
• UDI-Device Identifier: 07630030804076
• UDI-Public: 07630030804076
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K093944
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 08/23/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/23/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 04/30/2020
• Device Catalogue Number: 01.18.131
• Device Lot Number: 150841
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 07/24/2017
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 05/26/2015
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention