MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA STEM: QUADRA-C CEMENTED, MIRROR POLISHING STD STEM SIZE 0 12/14; CEMENTED HIP STEM

Catalog Number	01.12.040
Health Effect - Clinical Code	Joint Disorder (2373)
Date of Event	07/16/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Batch review performed on 31 october 2018; lot 168422: (b)(4) items manufactured and released on 11 april 2017.Expiration date: 2022-03-27.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.Preliminary investigation performed by r&d project manager: they did not respect the surgical technique using the implant as trial stem and, due to the fact that they did not have a stem extractor they didn't manage to remove the implant.
Event or Problem Description
During surgery the surgeon trialed the final implant.The femoral canal was very tight.The surgeon was only able to get down the 0 quadra broach.He then went to put down the smallest cement restrictor and it got stuck - would not budge.So he tried to see if the 0 cemented implant would fit down (prior to cementing) and tapped it a few times with the insertor; then he could not get the implant out as the screw in extractor was not in the set.As the patient was a low demand nursing home the surgeon elected to leave the cemented stem in uncemented and act as a pure wedge.The surgery was completed successfully.The patient did well for 2 months until she fell and fractured the lesser trochanter.During the revision the stem easily came out.Surgeon's plan was to cable the fx and cement in a smaller prosthesis.He cemented the 0 quadra after placing 3 cables (2 on the lesser piece and one in the subtrochanteric area to prevent any extension).

• Brand Name: STEM: QUADRA-C CEMENTED, MIRROR POLISHING STD STEM SIZE 0 12/14
• Common Device Name: CEMENTED HIP STEM
• Manufacturer (Section D): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, switzerland 6874 ; SZ 6874
• MDR Report Key: 8023979
• Report Number: 3005180920-2018-00848
• Device Sequence Number: 11090588
• Product Code: LZO
• UDI-Device Identifier: 07630030802218
• UDI-Public: 07630030802218
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K083558
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Device Explanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: other
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 10/31/2018

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: 03/27/2022
• Device Catalogue Number: 01.12.040
• Device Lot Number: 168422
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/03/2018
• Initial Report FDA Received Date: 10/31/2018
• 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: Other