MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA QUADRA-H CEMENTLESS, HA COATED LAT STEM SIZE 4; CEMENTLESS HIP STEM

Catalog Number	01.12.034
Health Effect - Clinical Code	Inadequate Osseointegration (2646)
Date of Event	05/07/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Batch review performed on 03 jun 2019: lot 083860: (b)(4) items manufactured and released on 25-feb-2009.Expiration date: 2014-01-31.No anomalies found related to the problem.To date, all the items of the same lot have been already sold without any similar reported event.Additional implants involved in the event- cup: versafitcup cc light 01.26.54mbtl acetabular shell cc light ø 54 (item not registered in usa), lot 083951: (b)(4) items manufactured and released on 25-feb-2009.Expiration date: 2014-01-31.No anomalies found related to the problem.To date, all the items of the same lot have been already sold without any similar reported event (neither metallosis nor osteolysis).Liner: cc e cc light 01.26.2844stt flat pe liner ø 28 / e (k103352) lot 072006: (b)(4) items manufactured and released on 28-sep-2007.Expiration date: 2012-07-31.No anomalies found related to the problem.To date, all the items of the same lot have been already sold without any similar reported event.
Event or Problem Description
Revision surgery after about 10 years after primary surgery due to acetabulum osteolysis, suspected pe wear, metallosis and stem loosening.The surgery was completed successfully.

• Brand Name: QUADRA-H CEMENTLESS, HA COATED LAT STEM SIZE 4
• Common Device Name: CEMENTLESS HIP STEM
• Manufacturer (Section D): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, 6874 ; SZ 6874
• MDR Report Key: 8670151
• Report Number: 3005180920-2019-00437
• Device Sequence Number: 16216206
• Product Code: JDI
• UDI-Device Identifier: 07630030802164
• UDI-Public: 07630030802164
• Combination Product (Y/N): N
• Initial Reporter Country: SZ
• PMA/510(K) Number: K082792
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2009
• Device Explanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 06/05/2019

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: 01/31/2014
• Device Catalogue Number: 01.12.034
• Device Lot Number: 083860
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/07/2019
• Initial Report FDA Received Date: 06/05/2019
• 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