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

Catalog Number	01.12.034
Health Effect - Clinical Code	Inadequate Osseointegration (2646)
Date of Event	01/10/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Batch review performed on 12 march 2019: lot 123766: (b)(4) items manufactured and released on 28-nov-2012.Expiration date: 2017-10-31.No anomalies found related to the problem.To date, (b)(4) items of this lot have already been sold without any other similar event reported.
Event or Problem Description
The patient had started to complain about hip pain on (b)(6) 2017, 4 years after primary.The x-ray had showed a shaft loosening.Since the symptoms were not that strong yet and there were muscular problems, they initially agreed on a physiotherapy with the instruction that if the pain intensified a stem change would have to be made.1 year and 8 months later, that means 5 years and 8 months after the primary case, the patient was revised, with exclusion of infection.The surgery was completed successfully replacing the stem.
Additional Manufacturer Narrative
On march 15, 2019 we received x-rays of the patient and they were evaluated as follows by the medical affairs manager: hip revision surgery occurred about 6 years after primary cementless total hip arthroplasty in an elderly woman (82 year old).Radiographic image provided shows the presence of radiolucent lines around the stem and signs of stress shielding suggesting implant mobilization.The stem looks slightly undersized but the reason of this choice cannot be assessed on the basis of a single pre-revision anteroposterior radiographic projection.Aseptic loosening is a possible literature described adverse event after cementless tha and causes are often unknown.The reason of this event cannot be determined.

• Brand Name: QUADRA-H CEMENTLESS LAT STEM SIZE 4
• Common Device Name: HIP STEM CEMENTLESS
• Manufacturer (Section D): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, switzerland 6874 ; SZ 6874
• MDR Report Key: 8421077
• Report Number: 3005180920-2019-00160
• Device Sequence Number: 2051744
• 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: 2013
• Device Explanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 04/11/2019

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: 10/31/2017
• Device Catalogue Number: 01.12.034
• Device Lot Number: 123766
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/15/2019
• Supplement Date Received by Manufacturer: 02/15/2019
• Initial Report FDA Received Date: 03/14/2019
• Supplement Report FDA Received Date: 04/11/2019
• 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: 82 YR