MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA STEM: QUADRA-H CEMENTLESS, HA COATED LAT STEM SIZE 2; STEM CEMENTLESS HA CAOTED

Model Number	01.12.032
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Bone Fracture(s) (1870)
Date of Event	12/31/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Batch review performed on 08-january-2021: lot 051660: (b)(4) items manufactured and released on 16-feb-2006.Expiration date: 31-dec-2010.No anomalies found related to the problem.To date, all items of the same lot have been already sold without any other reported event.Clinical evaluation performed by medacta medical affairs department: 9 years after tha the ceramic liner broke and was replaced with a new one.Shortly after this operation, the neck of the femoral stem fractured and this originated this failure report.It is very likely that the fracture of the ceramic liner, or possibly the revision operation, damaged the neck of the femoral stem and inititated a fatigue fracture.This could be verified through in-depth examination of the femoral stem.The fracture of femoral stem necks subsequent to revision surgeries where the femoral stem is left in situ is known and described in literature.We have no evidence that there is causality between the revision operation and the fracture of the neck but, based on our own experience, iit is highly probable.
Event or Problem Description
Revision surgery performed after about 10 years from the primary surgery due to femur bone fracture and the breakage of the stem neck.The patient already had many intermediate revision hip surgeries not involving the stem (the precedent to this revision surgery was a revision surgery for ceramic liner breakage).The removal of the explants performed on (b)(6) 2020 was done via posterior approach by a femoral flap.The acetabular shell was in good condition and was left in place.The ceramic liner was removed and replaced by a pe highcross inlay, the stem was replaced by a cementless stem and the femoral head was also replaced.
Event or Problem Description
Revision surgery performed after about 14 years from the primary surgery due to femur bone fracture and the breakage of the stem neck.The patient already had many intermediate revision hip surgeries not involving the stem.The removal of the explants performed on december 31st, 2020 was done via posterior approach by a femoral flap.The acetabular shell was in good condition and was left in place.The ceramic liner was removed and replaced by a pe highcross inlay, the stem was replaced by a cementless stem and the femoral head was also replaced.
Additional Manufacturer Narrative
Clinical evaluation perforemed by medacta medical affirs department.14 years after primary stem implantation in tha, the neck of the femoral stem fractured and this originated this failure report.In the meantime, the patient underwent several revision procedures, not all of them documented.Among them, at least one fracture of an unspecified ceramic inlay.It is very likely that the fracture of the ceramic liner, or possibly the revision operation, damaged the neck of the femoral stem and inititated a fatigue fracture.This could be verified through in-depth examination of the femoral stem.The fracture of femoral stem necks subsequent to revision surgeries where the femoral stem is left in situ is known and described in literature.We have no evidence that there is causality between the revision operation and the fracture of the neck but , based on our own experience, it is highly probable.Visual inspection performed by medacta r&d hip project manager: the femoral stem is fractured in 2 pieces in the neck portion: the proximal part is still connected to the ceramic femoral head, through a metallic sleeve.The ceramic femoral head has many scratches and gray signs that are probably due to the rubbing against metal surfaces, such as the fractured neck of the femoral stem.The proximal part of the neck has some scratches, with one deeper indentation on the top of the fractured zone.In particular a large burn halo it is visible on the top of the neck in correspondence of the fractured part.Also the stem part has the same scratches and a large burn halo.Looking at the fractured section, both on the neck and on the stem parts, waves of fatigue fracture are visibile coming out from the upper part of the neck, exactly where the burn halo is visible.It is assumable that the scratches on the neck have been created during the revision surgery of this patient but they are not the root cause of the reported fracture.The root cause of the event is likely the surface cracks that with time may lead to fracture of the involved region; the cracks are caused by some burns due to the electro-cutter or by some scratches during revision surgery.Based on the nature of the stem breakage and the visual inspection completed, it has been concluded that the fracture was triggered by surface damage, possibly due to interaction with a high-density power source (i.E.Electrosurgical knife) or high-energy contact with hard objects (e.G.Surgical instruments), that most likely happened during the revision.The batch record review does not indicate any potential manufacturing-related issue.

• Brand Name: STEM: QUADRA-H CEMENTLESS, HA COATED LAT STEM SIZE 2
• Common Device Name: STEM CEMENTLESS HA CAOTED
• Manufacturer (Section D): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, 6874 ; SZ 6874
• MDR Report Key: 11243438
• Report Number: 3005180920-2021-00073
• Device Sequence Number: 3718542
• Product Code: JDI
• UDI-Device Identifier: 07630030802140
• UDI-Public: 07630030802140
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: K082792
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Explanted Year: 2020
• 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): 05/19/2021

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: 12/31/2010
• Device Model Number: 01.12.032
• Device Catalogue Number: 01.12.032
• Device Lot Number: 051660
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/19/2021
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/29/2020
• Supplement Date Received by Manufacturer: 12/29/2020
• Initial Report FDA Received Date: 01/28/2021
• Supplement Report FDA Received Date: 05/19/2021
• 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