MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA STEM: QUADRA-H CEMENTLESS, HA COATED LAT SIZE 1; CEMENTLESS FEMORAL STEM

Model Number	01.12.031
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Fall (1848)
Date of Event	09/28/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Batch review performed on 10-nov-2021: lot 150210: 67 items manufactured and released on 15-apr-2015.Expiration date: 2020-02-29.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been sold without any similar reported event since the item release.Visual inspection: during the analysis it is evaluated that the neck of the stem is broken.Looking at the neck surfaces some signs and scratches are present.It is not possible to understand if the signs are caused during last revision surgery or if they are consequence of previous head revision surgeries.Some continuous signs are visible from the shoulder to the trunnion meaning that they were probably present before the neck breakage.We have analyzed the fracture section on the neck with the usage of a microscope and we found a burn mark close to the external surface.It seems that the surgeon hit the neck surface with electrocauterizing during surgeries.Additionally the breakage pattern suggest that the breakage was sudden, maybe during the fall of the patient (as reported in the event description).Additionally it is visible that the taper is connected with an high offset sleeve of competitor not approved by medacta.We have measured the resulting offset finding that it is 15mm larger than maximum offset expected with the use of medacta heads.This situation is such critical in terms of fatigue mechanical resistance of the neck because the level arm is increased introducing a new worst case in respect to what tested and validated by medacta.Following this analysis some issues are found even if it is not possible to determine a certain root cause of the reported stem neck breakage.
Event or Problem Description
After a fall, the stem neck broke, 5 years and 10 months after the primary surgery.The patient underwent revision surgery on (b)(6) 2017 due to an unknown reason, then due to a hip dislocation two close reductions has been performed and on (b)(6) 2017 the xl head was replaced with a 4xl head (it was used a 4xl sleeve not from medacta) due to an unknown reason.
Additional Manufacturer Narrative
On 10-january-2022 the visual inspection was updated.Visual inspection performed by r&d project manager during the analysis it is evaluated that the neck of the stem is broken.Looking at the stem is clearly is visible that the stem taper is connected with an high offset sleeve of competitor (merete bioball) not approved by medacta.We have measured the resulting offset finding that it is 15mm larger than maximum offset expected with the use of medacta heads.This situation is such critical in terms of fatigue mechanical resistance of the neck because the level arm is increased introducing a new worst case in respect to what tested and validated by medacta.Additionally in the ifu of merete bioball the following statement is reported: "no biomechanical testing information is available on the usage of bioball adapters with hip stems from other manufacturers.Consequently, only manufacturer-approved extensions may be used", confirming the unproper usage with medacta stems.Morever, looking at the neck surfaces some signs and scratches are present.It is not possible to understand if the signs are caused during last revision surgery or if they are conseguence of previous head revision surgeries.Some continuos signs are visible from the shoulder to the trunnion meaning that they were probably present before the neck breakage.We have analyzed the fracture section on the neck with the usage of a microscope and we found also a slight burn mark close to the external surface.It seems that the surgon hit the neck surface with electrocautering during surgeries.Additionally the breakage pattern suggest that the breakage was suddently, maybe during the fall of the patient (as repoted in the event description).

• Brand Name: STEM: QUADRA-H CEMENTLESS, HA COATED LAT SIZE 1
• Common Device Name: CEMENTLESS 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: 12878120
• Report Number: 3005180920-2021-00918
• Device Sequence Number: 4472844
• Product Code: JDI
• UDI-Device Identifier: 07630030802133
• UDI-Public: 07630030802133
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: K082792
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2015
• Device Explanted Year: 2021
• 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
• Report Date (Section B): 01/21/2022

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: 02/29/2020
• Device Model Number: 01.12.031
• Device Catalogue Number: 01.12.031
• Device Lot Number: 150210
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/19/2021
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/28/2021
• Supplement Date Received by Manufacturer: 10/28/2021
• Initial Report FDA Received Date: 11/26/2021
• Supplement Report FDA Received Date: 01/21/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/15/2015
• 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 Age: 61 YR
• Patient Sex: Male