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

Catalog Number	01.12.034
Health Effect - Clinical Codes	Pain (1994); Joint Disorder (2373)
Date of Event	08/15/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
On 08 september 2017 the medical affairs performed a clinical evaluation and commented as follows: partial hip (stem, head and liner) revision surgery occurred 3 years after primary cementless tha.Radiographic images provided show a loose stem, with no osseointegration.History and/or evolution of this case is not known: osseointegration may have started and then withdrawn for any of several reasons or it could never have started, which would be surprising as the patient maintained such condition for three years.Aseptic loosening is a possible, literature described adverse event after primary cementless tha and causes are often unknown.In this case, the reason of this event cannot be determined because information is insufficient.Batch review performed on 11 september 2017.Lot 143473: (b)(4) items manufactured and released on 09 september 2014.Expiration date: 2019-07-31.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.
Event or Problem Description
The patient complained of ongoing pain.The surgeon reviewed x-rays and suspected loosening of the stem.Revision surgery was undertaken and loose stem confirmed intra-operatively.It was removed and replaced.

• Brand Name: QUADRA-H CEMENTLESS, HA COATED STEM SIZE 4 LAT
• Common Device Name: CEMENTLESS FEMORAL STEM
• Manufacturer (Section D): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, 6874 ; SZ 6874
• MDR Report Key: 6860916
• Report Number: 3005180920-2017-00511
• Device Sequence Number: 890454
• Product Code: JDI
• UDI-Device Identifier: 07630030802164
• UDI-Public: 07630030802164
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K082792
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2014
• Device Explanted Year: 2017
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 09/13/2017

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: 07/31/2019
• Device Catalogue Number: 01.12.034
• Device Lot Number: 143473
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 08/15/2017
• Initial Report FDA Received Date: 09/13/2017
• 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