MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA STEM: QUADRA-H CEMENTLESS, HA COATED LAT STEM SIZE 1; CEMENTLESS HIP STEM

Catalog Number	01.12.031
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	12/10/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Batch review performed on (b)(6) 2019: lot 050833: 24 items manufactured and released on (b)(6) 2005.Expiration date: (b)(6) 2010.No anomalies found related to the problem.To date, all the items of this same lot have been already sold without any similar reported event.
Event or Problem Description
Revision surgery performed 13 years after primary due to peri-prosthetic metallosis on the proximal part of the stem and on the periphery of the non-medacta cup.No invasion of the joint capsule.Liner and head were ceramic implants.The surgeon revised the stem with a quadra r size 1.
Additional Manufacturer Narrative
Visual inspection performed by r&d project manager visual inspection performed on 23rd september 2019.The ha coating of the stem was almost totally absorbed and lots of scratches were visible in the neck region, probably some occurred during the revision; anyway, it is not clear if some of these scratches are related to impingement with other products, as the competitor's cup geometry is unknown.From the received piece it is not possible to determine with certainty the root cause of the event, but it could be related to the competitor's cup.

• Brand Name: STEM: QUADRA-H CEMENTLESS, HA COATED LAT STEM SIZE 1
• Common Device Name: CEMENTLESS HIP STEM
• Manufacturer (Section D): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, 6874 ; SZ 6874
• MDR Report Key: 8230879
• Report Number: 3005180920-2018-01076
• Device Sequence Number: 195338
• Product Code: JDI
• UDI-Device Identifier: 07630030802133
• UDI-Public: 07630030802133
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: K082792
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2005
• Device Explanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 10/17/2019

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: 05/31/2010
• Device Catalogue Number: 01.12.031
• Device Lot Number: 050833
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/17/2019
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/10/2018
• Supplement Date Received by Manufacturer: 12/10/2018
• Initial Report FDA Received Date: 01/09/2019
• Supplement Report FDA Received Date: 10/17/2019
• 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: 63 YR