MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA AMISTEM H, HA COATED STEM SIZE 6 STD; CEMENTLESS FEMORAL STEM

Catalog Number	01.18.136
Health Effect - Clinical Code	Joint Disorder (2373)
Date of Event	07/28/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
On 18 august 2017 the medical affairs performed a clinical evaluation and commented as follows: partial revision on a cementless primary tha after 1,5 years.The quality of the available x-rays is extremely poor and no real assessment can be made.It appears that the stem is proximally debonded and radiographically loose.Some black shadows, both proximally and distally, are visible, but we cannot determine whether they are visual artefacts or signs of a specific situation.The root cause for this failure cannot be determined with the information at hand.Batch review performed on 22 august 2017.Lot 140016: (b)(4) items manufactured and released on 08 april 2014.Expiration date: 2019-02-28.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
Revision surgery performed due to stem loosening, 1 year and 5 months after primary surgery.The stem was easily removed with the extractor.It seems that the prosthesis never really integrated into the metaphyseal part and the patient has always been painful.
Additional Manufacturer Narrative
On 13 september 2017 the r&d project manager performed a visual inspection of the retrieved items and commented as follows: the stem was analyzed.The ha coating was totally absorbed in the distal region while in metaphysial area was still present, indicating an unproper fixation in the proximal region that could have caused the pain in the patient.Fibrotic tissues was noticed in some macrostructures and a small groove was present under the taper, probably occurred during the revision.The ceramic ball head showed some signs on the rim, probably occurred during the extraction from the stem.From the received pieces it was not possible to determine the root cause of the event.

• Brand Name: AMISTEM H, HA COATED STEM SIZE 6 STD
• Common Device Name: CEMENTLESS FEMORAL STEM
• Manufacturer (Section D): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, 6874 ; SZ 6874
• MDR Report Key: 6819962
• Report Number: 3005180920-2017-00476
• Device Sequence Number: 10773473
• Product Code: LZO
• UDI-Device Identifier: 07630030804120
• UDI-Public: 07630030804120
• 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: 2016
• Device Explanted Year: 2017
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 10/04/2017

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: 02/28/2019
• Device Catalogue Number: 01.18.136
• Device Lot Number: 140016
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/05/2017
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 07/28/2017
• Supplement Date Received by Manufacturer: 07/28/2017
• Initial Report FDA Received Date: 08/25/2017
• Supplement Report FDA Received Date: 10/04/2017
• 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: 59 YR
• Patient Weight: 83