MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA AMISTEM-H PROXIMAL COATING STEM SIZE 5 STD; CEMENTLESS FEMORAL STEM

Catalog Number	01.18.175
Health Effect - Clinical Code	Unspecified Infection (1930)
Date of Event	09/04/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
On 29 september 2017 the manufacturer of the ceramic components involved in this case (not marketed in the us), provided a document review for the lots involved, reporting as follows: the component properties and the microstructure as obtained from the quality documents accomplish the requirements as specified at the time of production.There are no indications of any pre-existing material defect or non-conformities regarding sterilisation.Due to a lack of ceramic parts further investigations cannot be done.Batch reviews performed on 04 october 2017.(b)(4).
Event or Problem Description
The patient complained of a febrile infectious syndrome.The surgeon revised the patient due to infection (streptococcus b), swapping successfully the stem, the head and the liner.The surgery was completed successfully.
Additional Manufacturer Narrative
On (b)(6) 2017 the r&d project manager performed a visual inspection of the retrieved items and commented as follows: the parts were observed.The stem had the coating partially absorbed (it was remained in the proximal region).Some scratches were noticed in the neck and taper, occurred during the revision, and some fibrotic tissue was observed in the macrostructures.The cup revealed some grooves in the rim, most probably occurred during the removal.The ceramic liner and head did not show particular signs.From the received pieces it was not possible to determine the route cause of the event.

• Brand Name: AMISTEM-H PROXIMAL COATING STEM SIZE 5 STD
• Common Device Name: CEMENTLESS FEMORAL STEM
• Manufacturer (Section D): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, 6874 ; SZ 6874
• MDR Report Key: 6917384
• Report Number: 3005180920-2017-00550
• Device Sequence Number: 19050892
• Product Code: LZO
• UDI-Device Identifier: 07630030804403
• UDI-Public: 07630030804403
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: K161635
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Device Explanted Year: 2017
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 11/17/2017

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: 09/19/2021
• Device Catalogue Number: 01.18.175
• Device Lot Number: 164519
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/18/2017
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 09/05/2017
• Supplement Date Received by Manufacturer: 09/05/2017
• Initial Report FDA Received Date: 10/05/2017
• Supplement Report FDA Received Date: 11/17/2017
• 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: 51 YR
• Patient Weight: 115