MAUDE Adverse Event Report: AESCULAP INC UNISYN STEM STRAIGHT 16 X 190; HIP ENDOPROSTHETICS

Model Number 3422-11619

Device Problem Break (1069)

Patient Problem Joint Disorder (2373)

Event Date 12/31/2018

Event Type  Injury  

Manufacturer Narrative

Additional information / investigation results will be provided in a supplemental report, if available.

Event Description

It was reported that there was a postoperative issue with a unisyn stem.The initial implant date was (b)(6) 2010, when the patient underwent left hip arthroplasty.On approximately (b)(6) 2018, the patient's hip "popped" during normal daily activities and a fall occurred.This resulted in a fracture of the femoral stem and there was a revision surgery on (b)(6) 2019.The femoral component was replaced along with extended trochanteric osteotomy.The fracture had been noted at the proximal modular junction, with intact acetabular component; no signs of infection or complications.Treatment included antibiotics as prophylaxis.Additional information has been requested.Concomitant parts: (to be confirmed).Aesculap cup, liner, femoral head, cancellous screws.Competitor femoral neck and nut.

Manufacturer Narrative

Operative findings - fractured femoral stem, intact acetabular component, no obvious signs of infection, no evidence of metallosis.Extended trochanteric osteotomy performed and joint replacement with nonaesculap implants.Involved components: (left hip) - updated [some numbers in the original record were blurred].Body, standard 3461-42630-a, lot 271159.Neck, standard 3441-13642-a, lot 472115.Lock nut 3449-06000-0, lot 720010.Femoral head 0007-1-3602, lot 170845.Acetabular shell 1706-0-0064, lot 740214.Acetabular insert 1008-0-3664, lot 750171.3 bone screws, cancellous 0013-1-6535, lot 232807 and 0013-1-6525, lot 232685a and 0013-1-6525, lot 232518.Product evaluation - no radiographs provided; no explants provided for investigation.Device history review - records were evaluated for all implant components installed at primary surgery.All components were cleaned, packaged and eo sterilized per validated processes.The stem had been re-sterilized per validated procedures prior to use.Instrument lots were inspected according to appropriate procedures and included 100% visual inspection.Per required inspection procedures we know that the hip stem, lock nut and acetabular shell were dimensionally inspected prior to implantation.It is unknown whether the remaining implanted components were dimensionally inspected but all components that were inspected were considered acceptable for use.Discussion - without an exact understanding of the activites leading up to the fracture it is impossible to determine whether the patient's activity had an impact on the fracture of the implant.Additionally it is unclear what the exact nature of the fracture was; without additional detail we cannot determine the exact location of the fracture.No explants or radiographs were provided to aid in evaluation.An evaluation of the dhr was conducted and shoed that all components that were inspected were considered acceptable for use.Due to the limited information available the cause of the stem fracture remains unknown.

• Brand Name: UNISYN STEM STRAIGHT 16 X 190
• Type of Device: HIP ENDOPROSTHETICS
• Manufacturer (Section D): AESCULAP INC; 3773 corporate parkway; center valley PA 18034
• MDR Report Key: 10093012
• MDR Text Key: 194952637
• Report Number: 2916714-2020-00162
• Device Sequence Number: 1
• Product Code: LWJ
• Combination Product (y/n): N
• PMA/PMN Number: K003649
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,other
• Type of Report: Initial,Followup
• Report Date: 12/18/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/27/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 3422-11619
• Device Catalogue Number: 3422-11619
• Device Lot Number: 490210AB
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 07/01/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 62 YR