MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA STEM: QUADRA-H CEMENTLESS, HA COATED STD STEM SIZE 1, SHORT NECK; UNCEMENTED HIP STEM

Catalog Number	01.12.21SN
Health Effect - Clinical Code	Joint Disorder (2373)
Date of Event	12/05/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Batch review performed on 29 november 2019: lot 090847: (b)(4) items manufactured and released on 06-may-2009.Expiration date: 2014-03-31.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been already sold, without any similar event reported.Clinical evaluation performed by medacta medical director: hip revision surgery performed 10 months after cementless primary total hip arthroplasty.No information concerning patient age, activity level and comorbidities is available nor immediate postoperative images.The pre-revision xray shows a clearly undersized stem that subsided.An estimation of undersizing based on one projection is very unreliable, so it must be taken as estimation only.The acetabular cup is shown to be too vertical, and again we do not know if that is the result of migration or it was the original placement and in this case, for what reason this position was chosen.No further conclusion can be drawn with the limited information at hand.Preliminary investigation performed by medacta r&d hip project manager: implants are covered in biological fluids.It is not possible to determine any possible failure root cause.
Event or Problem Description
Revision surgery performed, 10 months after primary surgery, due to pain.Stem has been successfully removed.

• Brand Name: STEM: QUADRA-H CEMENTLESS, HA COATED STD STEM SIZE 1, SHORT NECK
• Common Device Name: UNCEMENTED HIP STEM
• Manufacturer (Section D): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, 6874 ; SZ 6874
• MDR Report Key: 9493949
• Report Number: 3005180920-2019-01074
• Device Sequence Number: 1541931
• Product Code: JDI
• UDI-Device Identifier: 07630030802614
• UDI-Public: 07630030802614
• 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: 2019
• Device Explanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 12/19/2019

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: 03/31/2014
• Device Catalogue Number: 01.12.21SN
• Device Lot Number: 090847
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/26/2019
• Initial Report FDA Received Date: 12/19/2019
• 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