MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA QUADRA-H CEMENTLESS, HA COATED STEM SIZE 2 STD; CEMENTLESS FEMORAL STEM

Catalog Number	01.12.022
Health Effect - Clinical Code	Joint Disorder (2373)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
On 20 october 2017 the medical affairs director performed a clinical evaluation and commented as follows: partial hip revision surgery occurred 4 years after primary cementless total hip arthroplasty.According to the report the stem was completely loose.The radiographic image provided shows the presence of areas of bone resorption in the greater trochater region and massive osteolysis around the stem.Sometimes similar situations are caused by polyethylene wear debris but this does not seem to be the case because there is no visible eccentricity of the head; besides, such a reaction on a highly-crosslinked polyethylene liner after 4 years would be exceptional.Therefore, in our opinion a different cause for osteolysis and bone resorption should be sought, such as silent infection, but of course we do not have the elements to support such hypothesis.Batch review performed on 23 october 2017.(b)(4).
Event or Problem Description
Revision due to stem loosening.The stem was completely loose and has been replaced.Liner and ball head have also been replaced.

• Brand Name: QUADRA-H CEMENTLESS, HA COATED STEM SIZE 2 STD
• Common Device Name: CEMENTLESS FEMORAL STEM
• Manufacturer (Section D): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, 6874 ; SZ 6874
• MDR Report Key: 6983010
• Report Number: 3005180920-2017-00616
• Device Sequence Number: 1228410
• Product Code: LZO
• UDI-Device Identifier: 07630030802034
• UDI-Public: 07630030802034
• 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: 2013
• Device Explanted Year: 2017
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 10/26/2017

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: 08/31/2019
• Device Catalogue Number: 01.12.022
• Device Lot Number: 132656
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 09/27/2017
• Initial Report FDA Received Date: 10/27/2017
• 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 Weight: 78