MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA QUADRA-H CEMENTLESS, HA COATED STEM SIZE 6 STD; CEMENTLESS FEMORAL STEM

Catalog Number	01.12.026
Health Effect - Clinical Code	Unspecified Infection (1930)
Date of Event	08/23/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
On (b)(6) 2017 the medical affairs director performed a clinical evaluation and commented as follows: late infection in cementless tha, 7.5 years after primary operation.Infection is a known possible adverse event following every surgery, including tha's.To date, there is no reason to suspect that the cause may be linked to the implanted devices.Batch reviews performed on 18 september 2017.Lot 082253: (b)(4) items manufactured and released on 23 september 2008.Expiration date: 2013-08-31.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been already sold without any similar reported event.Cocr ball head 12/14 ø 28 size m 0, code 01.25.012, lot.083350 (k072857) (b)(4) items manufactured and released on 23 february 2009.Expiration date: 2014-01-31.No anomalies found related to the problem.To date, all items of the same lot have been already sold without any similar reported event.Versafitcup acetabular shell cc light ø 50, code 01.26.50mbtl, lot.083394 (not marketed in us) (b)(4) items manufactured and released on 18 december 2008.Expiration date: 2013-11-30.No anomalies found related to the problem.To date, all items of the same lot have been already sold without any similar reported event.Versafitcup flat pe liner ø 28 / c, code (b)(4), lot.081408 (k103352) (b)(4) items manufactured and released on 28 july 2008.Expiration date: 2013-06-30.No anomalies found related to the problem.To date, all items of the same lot have been already sold without any similar reported event.
Event or Problem Description
Revision performed due to low grade infection.

• Brand Name: QUADRA-H CEMENTLESS, HA COATED STEM SIZE 6 STD
• Common Device Name: CEMENTLESS FEMORAL STEM
• Manufacturer (Section D): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, 6874 ; SZ 6874
• MDR Report Key: 6878305
• Report Number: 3005180920-2017-00527
• Device Sequence Number: 13632966
• Product Code: JDI
• UDI-Device Identifier: 07630030802072
• UDI-Public: 07630030802072
• 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: 2017
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 09/20/2017

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: 08/31/2013
• Device Catalogue Number: 01.12.026
• Device Lot Number: 082253
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 08/23/2017
• Initial Report FDA Received Date: 09/20/2017
• 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: 89 YR
• Patient Weight: 90