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

Catalog Number	01.12.024
Health Effect - Clinical Code	No Code Available (3191)
Date of Event	08/22/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Batch review performed on 09 july 2019: lot 110577: (b)(4) items manufactured and released on 11-"mag"-2011.Expiration date: 2016-03-31.No anomalies found.To date, (b)(4) items of the same lot have been already sold without any event reported.Other devices were involved in the event, batch review performed on 09 july 2019: cup: versafitcup cc trio 01.26.45.0056 acetabular shell cc trio ø 56 lot.104042 (k103352): (b)(4)items manufactured and released on 28-feb-2011.Expiration date: 2016-01-31.No anomalies found.To date, (b)(4) items of the same lot have been already sold without any event reported.Liner: cc e cc light 01.26.3648hct flat pe hc liner ø 36 / f lot.110577 (k103352): (b)(4) items manufactured and released on 15-nov-2010.Expiration date: 2015-09-30.No anomalies found.To date, (b)(4) items of the same lot have been already sold without any event reported.Ball heads: mectacer 38.49.7179.285.00 biolox delta ceramic ball head 12/14 ø 36 size m 0 lot.666512 (item not registered in usa).
Event or Problem Description
About 8 years after primary the surgeon plans to revise the patient hip.The reason of revision is unknown for the moment.The surgeon plans to revise the liner, ball head and the stem.
Event or Problem Description
About 8 years after primary revision surgery for stem aseptic loosening.The surgeon revised successfully the stem and head.

• Brand Name: STEM: QUADRA-H CEMENTLESS, HA COATED STD STEM SIZE 4
• Common Device Name: HIP CEMENTLESS STEM
• Manufacturer (Section D): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, 6874 ; SZ 6874
• MDR Report Key: 8780215
• Report Number: 3005180920-2019-00562
• Device Sequence Number: 2639161
• Product Code: JDI
• UDI-Device Identifier: 07630030802058
• UDI-Public: 07630030802058
• 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: 2011
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 10/11/2019

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: 03/31/2016
• Device Catalogue Number: 01.12.024
• Device Lot Number: 110577
• Initial Date Received by Manufacturer: 06/14/2019
• Supplement Date Received by Manufacturer: 06/14/2019
• Initial Report FDA Received Date: 07/11/2019
• Supplement Report FDA Received Date: 10/11/2019
• 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: 77 YR