MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA STEM: QUADRA-H CEMENTLESS, HA COATED LAT STEM SIZE 5, SHORT NECK; HIP FEMORAL STEM

Model Number	01.12.35SN
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	Fall (1848)
Date of Event	02/02/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Batch review performed on 9 february 2022.Lot 102366: (b)(4) items manufactured and released on 16-sep-2010.Expiration date: 2015-aug-31.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been sold with no similar reported event.Preliminary investigation performed by r&d project manager.Based on event description the patient fell down in bathroom and after the event it is reported the breakage of the stem neck (size 5lat coupled with head 28xxl).It is not possible to evaluate if the breakage occurred due to the fall or if the patient fell down consequently to the stem neck breakage.Looking at the images attached to the complaint it is visible that the neck of the stem is broken.It is visible that, on the broken surface, there is a stair on the posterior side, it seems that the breakage occurs with a sudden bent.Unfortunately the broken surface is not clearly visible, for this reason it is not possible to evaluate if fatigue breakage waves (fatigue breakage) are present of not.Additionally also the upper part of the neck surface is not visible, for this reason it is not possible to evaluate if some signs of elecrocautering or scratches are present or not.Due the fact that the implant will not be available for the visual inspection we are not able to add more details to this analysis.The root cause of reported neck breakage is unknown.
Event or Problem Description
Revision surgery was performed 7 years and 2 months after the primary surgery because of a stem neck fracture after the patient fell (walking to the bathroom, turned his leg and fell).Stem body and cup were solidly attached, cup and stem were retroverted.Stem, trunnion, and acetabular components were removed.The acetabular component was removed to allow the insertion of a larger component.
Additional Manufacturer Narrative
Device returned on 28 august 2024 and further comprehensive evaluation will be performed.
Additional Manufacturer Narrative
Investigation performed by r&d project manager.All devices were received for analysis (stem, cup, head, liner).Looking at the stem body, it can be seen that the neck portion is broken approximately in the central region.The fractured surface shows a clear pattern of fatigue failure, with a step in the middle.Looking at the rim of the cup, some wear is visible and it is presumable that the neck stem has had repeated impacts with the cup.Looking at the outer surface of the liner, some scratches are visible, probably due to metal debris detached from the breakage of the neck stem and/or the rim of the cup.In addition, there are some huge marks on both the body of the stem and the outer surface of the cup, probably due to the revision surgery and not pertinent to the reported problem.Impingement marks correspond to the fracture initiation point; therefore, we can state that the stem breakage was initiated by the weakening of the stem due to impingement with the cup.
Additional Manufacturer Narrative
On (b)(6) 2024 we received the xrays.Clinical evaluation performed by medical affairs department in 2022, revision surgery was undertaken on a patient whose tha stem had fractured.Now, explants and some xray pictures are available.The system remained in situ for 7 years, despite rather evident malposition of the cup (retroverted and grossly horizontal) and probably some retroversion of the stem too.Also, the head used was an xl head, with a metal sleeve that envelops the stem neck, reducing the range of motion.Due to the suboptimal orientation of the components, impingement between the stem neck and cup rim was repeatedly taking place, presumably at hip flexion and surely at hip abduction (and combinations of the two).The location of impingement is very clearly marked on the stem neck and the cup rim.After years of progressive wear of the titanium alloy (the stem) by the harder stainless steel alloy (the cup), the resisting section decreased to the point of rupture and the neck broke, in the absence of a traumatic event.The cause for this event is clearly cup (and partially stem) malposition at primary surgery.

• Brand Name: STEM: QUADRA-H CEMENTLESS, HA COATED LAT STEM SIZE 5, SHORT NECK
• Common Device Name: HIP FEMORAL STEM
• Manufacturer (Section D): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, 6874 ; SZ 6874
• Manufacturer (Section G): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, 6874 ; SZ 6874
• Manufacturer Contact: stefano baj ; strada regina; castel san pietro, switzerland 6874 ; SZ 6874
• MDR Report Key: 13706924
• Report Number: 3005180920-2022-00156
• Device Sequence Number: 12095475
• Product Code: LZO
• UDI-Device Identifier: 07630030802751
• UDI-Public: 07630030802751
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• PMA/510(K) Number: K093944
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2014
• Device Explanted Year: 2022
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 10/17/2024

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: 08/31/2015
• Device Model Number: 01.12.35SN
• Device Catalogue Number: 01.12.35SN
• Device Lot Number: 102366
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/07/2022
• Supplement Date Received by Manufacturer: Not provided; Not provided; Not provided
• Initial Report FDA Received Date: 03/09/2022
• Supplement Report FDA Received Date: 09/27/2024; 10/01/2024; 10/17/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/16/2010
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Male