MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA ACETABULAR SHELL CC TRIO Ø 54; ACETABULAR HIP CUP

Catalog Number	01.26.45.0054
Health Effect - Clinical Code	Joint Disorder (2373)
Date of Event	12/01/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The head and the liner dislocated are not marketed in us.Clinical evaluation performed on 21 december 2017 by medical affairs director: immediate postoperative revision due to hip dislocation.The single image provided shows the presence of migrated acetabular shell.The pre-dislocation implants position cannot be assessed on the basis of available information.The cause of this event cannot be determined but it's likely due to insufficient primary stability achieved at surgery.Batch review performed on 29 december 2017.(b)(4).
Event or Problem Description
The same day of primary surgery the patient luxated his hip for an involuntary contraction.After a first anatomical reduction the patient hip re-luxated and this time a cup migration was detected.The surgeon revised the patient the same day swapping successfully the cup implants and the stem head.
Additional Manufacturer Narrative
Visual inspection performed on 29 january 2018 by r&d product manager: liner and shell (not marketed in us) arrived disassembled for visual inspection.Couple of scratches were found on the taper surface of the acetabular shell.Few metal transfer scratches were found on the articulating surface of the ceramic liner.In both cases they are probably due to removal process.The probable cause of acetabular shell mobilization was the anatomical reduction procedures together with poor initial shell fixation.
Event or Problem Description
The same day of primary surgery the patient luxated his hip for an involuntary contraction.After a first anatomical reduction the patient hip re-luxated and this time a cup migration was detected.The surgeon revised the patient the same day swapping successfully the cup implants and the stem head.

• Brand Name: ACETABULAR SHELL CC TRIO Ø 54
• Common Device Name: ACETABULAR HIP CUP
• Manufacturer (Section D): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, 6874 ; SZ 6874
• MDR Report Key: 7153831
• Report Number: 3005180920-2017-00797
• Device Sequence Number: 16161342
• Product Code: LZO
• UDI-Device Identifier: 07630030807787
• UDI-Public: 07630030807787
• Combination Product (Y/N): N
• Initial Reporter Country: IT
• PMA/510(K) Number: K103352
• 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): 02/15/2018

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: 10/10/2017
• Device Catalogue Number: 01.26.45.0054
• Device Lot Number: 173551
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/17/2018
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 12/01/2017
• Supplement Date Received by Manufacturer: 12/01/2017
• Initial Report FDA Received Date: 12/29/2017
• Supplement Report FDA Received Date: 02/15/2018
• 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: 60 YR
• Patient Weight: 90