MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA MINIMAX CEMENTLESS FEMORAL STEM

Catalog Number	01.13.104R
Health Effect - Clinical Code	Joint Disorder (2373)
Date of Event	11/22/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
On (b)(6) 2017 the medical affairs director made the following analysis: early subsidence of an anatomic cementless stem in primary thr.Evidence of significant fracture can be drawn from the radiographs supplied; no mention of traumatic events.The reason for the fracture and the subsidence is not known, nor can we determine which happened first.One possibility is the insertion of an undersized stem that was unable to find sufficient stability, but of course other reasons may apply.Batch review performed on (b)(6) 2017, lot 160265: 16 items manufactured and released on 18 may 2016.Expiration date: (b)(6) 2021.No anomalies found related to the problem.To date, 12 items of the same lot have been already sold without any similar reported event.
Event or Problem Description
Following the primary surgery the review of the patient discovered that the stem had subsided and a greater trochanteric fracture was present.The revision surgery was completed successfully using a revision stem and cables.As the acetabulum is a dm cup a new liner and ceramic had was also implanted.Although subsided, the stem displayed excellent on-growth and stability within the canal as such it was difficult to explant.The cup was not touched.
Additional Manufacturer Narrative
On (b)(6) 2018 the r&d project manager checked the explant device commenting as following: the minimax stem was analyzed.The surface showed the coating absorbed in some areas, especially in extradox and intradox, where the maximum contact is supposed to be form the x-rays image.No other particular signs were noticed, and from the received piece it is not possible to determine the root cause of the event.

• Brand Name: MINIMAX CEMENTLESS FEMORAL STEM
• Common Device Name: CEMENTLESS FEMORAL STEM
• Manufacturer (Section D): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, 6874 ; SZ 6874
• MDR Report Key: 7142941
• Report Number: 3005180920-2017-00767
• Device Sequence Number: 19151419
• Product Code: LZO
• UDI-Device Identifier: 07630030803291
• UDI-Public: 07630030803291
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K170845
• 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): 01/18/2018

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: 04/07/2021
• Device Catalogue Number: 01.13.104R
• Device Lot Number: 160265
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/19/2017
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 11/22/2017
• Supplement Date Received by Manufacturer: 11/22/2017
• Initial Report FDA Received Date: 12/22/2017
• Supplement Report FDA Received Date: 01/19/2018
• 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: 73 YR