MAUDE Adverse Event Report: ZIMMER GMBH BIOLOX DELTA, CERAMIC FEMORAL HEAD, L, ø 36/+3.5, TAPER 12/14

Model Number N/A

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problems Bone Fracture(s) (1870); Unspecified Infection (1930)

Event Date 12/15/2011

Event Type  Injury  

Manufacturer Narrative

Medical product: revitan, proximal part, cylindrical, uncemented, 75, taper 12/14; catalog# : 0595001052; lot# : unknown, revitan, distal part, curved, uncemented, 16/140; catalog# : 0100406116; lot# : unknown, reinforcement ring with hook, 56; catalog# : 94162356; lot# : unknown, durasul, low profile cup, cemented, 52/36; catalog# : 0100402075; lot# : unknown, therapy date: (b)(6) 2011.The manufacturer did not receive x-rays for review.The manufacturer did not receive the device for investigation.As no lot number was provided, the device history records could not be reviewed.A cause for this specific event cannot be ascertained from the information provided.As soon as supplemental information becomes available an updated report will be submitted.Zimmer biomet¿s reference number of this file is (b)(4).

Event Description

Patient was implanted on the right side and underwent revision surgery due to infection and periprosthetic fracture.

Event Description

Investigation results are now available.

Manufacturer Narrative

Trend analysis: no trend has been identified.Event description: it was reported that the patient had the products implanted on the (b)(6) 2011, underwent surgery due to periprosthetic fracture on the (b)(6) 2011, had an additional surgical intervention on the (b)(6) 2011 due to infection and a subsequent revision surgery on the (b)(6) 2011 due to persistent infection, whereby all the implanted products were explanted.Review of received data: - primary surgical report received dated (b)(6) 2011.Total hip arthroplasty was conducted on the right hip due to previous shaft loosening due to abrasion and also due to stem fracture.Osteolysis was identified around the cup.Window-osteotomy had to be carried out to remove the fractured stem.However, due to cement having leaked approx.10cm further distally from the fractured stem and having massively fused with the corticalis, an additional window had to be carried out to remove the excess cement.The femur was noted as being extremely in risk of a fracture due to the double window-osteotomy.Several cerclage wires had therefore have to be used to provide support.During removal of the cup, a defect in the roof of the acetabulum in the size of a thumb was identified due to osteolysis.This defect has to be filled up with spongiosa.The acetabulum was prepared but is not suitable for receiving a press-fit cup due to a severe ventral defect.Therefore augmentation with a reinforcement ring with hook.Cementing a size 52 polyethylene cup into the 56 reinforcement ring with hook.To support the postoperative mobilisation due to a risk of fracture of the femur due to double window-osteotomy, the cerclage wires were replaced with a plate on the lateral femur and fixated with screws.Postoperative imaging show a good placement of stem and plate.Postoperative rehabilitation procedure has been given.- surgical report received dated (b)(6) 2011.Indication for surgery is a periprosthetic femur fracture on the right side (vancouver b1).Material used for osteosynthesis procedure in previous surgery ((b)(6) 2011) were removed.A 18-hole plate was implanted with screws.Fracture site is noted as being between the tip of the shaft implanted on the (b)(6) 2011 and the plate which was implanted on the (b)(6) 2011 at the site of the windowing done.Fracture noted as being diagonal.All fragments were removed from the site.In the proximal part of the plate only 4mm screws could be accepted and implanted due to the revitan stem.These screws were however noted as being properly sitting.Additional proximal security and support provided by two thick cerclage wires used from the dall-miles system.The screws were deliberately not screwed in at the area of fracture.X-ray documentation show good positioning of the implants.- surgical report received dated (b)(6) 2011.Indication for surgery is infection post osteosynthesis procedure dated (b)(6) 2011.An implant-preserving surgery was carried out on the (b)(6) 2011 as well as debridement and the placement of septopal-chains.The decision to carry out a implant-preserving surgery was due to the short time-frame since the last surgery ((b)(6) 2011).The plate has been noted as being stable.30 septopal-chains were placed on the plate.Planned revision surgery to take place in 7-10 days.- surgical report for the revision surgery dated (b)(6) 2011 received.Indication for surgery is persistent case of infection post total hip arthroplasty and post osteosynthesis procedure.All metal components (total endoprosthesis and osteosynthesis components) were explanted from the patient.The plate was noted of being completely surrounded by pus.Prior to removing the plate, the total endoprosthesis was removed first.The joint shows signs of inflammation, however no purulent liquid could be seen.Samples taken for testing.The revitan shaft could be removed easily.The cup was removed with all foreign material.Debridement of the joint was done.Resection of all inflamed tissue was carried out.Ossification in the fracture area were removed, as inflammatory assertion is suspected.For the intramedullary splinting two kirschner-wires are coated with bone cement.After a marrow-like drug carrier has set, it is threaded proximally to the fracture to be splinted.X-ray imaging confirm all metal components were removed during the procedure.- discharge report received post primary surgery dated (b)(6) 2011.Blood transfusions for anemia were noted and the patient was placed in the icu post-surgery and then in the normal unit on the (b)(6) 2011.Urinary tract infections (uti) was identified and treated on the(b)(6) 2011.Further rehabilitation and therapy notes are given in the report.- discharge report received post surgery due to periprosthetic fracture dated (b)(6) 2011.Blood transfusions for anemia was noted.The wound healing was primarily carried out in wound conditions that were not irritating at any times.Hemoglobin had to be transfused to the patient.Postoperative edematous swelling of the right leg without any signs of dvt was noted.These findings were regressive due to lymph drainage carried out on an inpatient basis.Protein-containing nutrition was recommended to the patient as well as the continuation of the therapy listed in the discharge report.- discharge report received post surgery dated (b)(6) 2011 and post revision surgery dated (b)(6) 2011.Blood transfusion was noted.Treatment with antibiotics (antibiosis).Patient to be immobilized 1 week postoperative and then to use a wheelchair with a knee-mobilizer.If applicable, lavage in stages and a change of the spacer 4 weeks postoperative.Thrombosis prevention treatment done.The patient complained of a week of persistent wound secretion from the middle wound pole (wound dehiscence approx.2.0 to 3.0 cm) post surgery dated (b)(6) 2011.Para-clinical inflammatory values were moderately increased.The removed material from the surgery dated (b)(6) 2011 was sent to the lab.Enterococcus faecalis was identified, which is why treatment with ampicillin was done.Due to persisting infection with continuous wound secretion a revision surgery was carried out on the (b)(6) 2011.Para-clinical inflammatory values showed signs of decrease after discharge.- revitan hip study adverse event report for the products implanted on (b)(6) 2011 received.Adverse events such as periprosthetic fracture, early infection and periprosthetic infection noted.Devices analysis: - no product was returned to zimmer biomet for in-depth analysis.Review of product documentation: - all involved devices are intended for treatment.- the compatibility check was performed from and showed that the product combination was approved by zimmer biomet.Conclusion summary: it was reported that the patient had the products implanted on the (b)(6) 2011, underwent surgery due to periprosthetic fracture on the (b)(6) 2011, had an additional surgical intervention on the (b)(6) 2011 due to infection and a subsequent revision surgery on the (b)(6) 2011 due to persistent infection, whereby all the products were explanted.The investigation results did not identify a non-conformance or a complaint out of box (coob).Review of the quality records (material, dimension, sterilization certificate) could not be conducted as the lot numbers of all records have not been provided.Medical documentation in form of surgical reports and discharge reports were provided.However, no x-rays were provided.The primary surgical report dated (b)(6) 2011 describes a window-osteotomy being carried out twice for the removal of the previous stem and the excess cement distal of the stem.The femur was thereafter noted as being extremely prone and in risk of fracturing.The femur was therefore supported with the implantation of a plate with screws.Postoperative rehabilitation protocol was provided to the patient.X-ray imaging showed good placement of the stem and plate.Blood transfusion for anemia was noted.Patient suffered from urinary tract infection (uti) and treated on the (b)(6) 2011.However, the periprosthetic fracture did occur approx.3 weeks after on the (b)(6) 2011.The fracture site was noted as being between the tip of the shaft and the plate, around the site of the window-osteotomy.Thereafter another plate had to be implanted to support osteosynthesis as well as two thick cerclage wires.The screws were noted as deliberately not being screwed in at the area of fracture.Blood transfusion for anemia was noted.Post operative edematous swelling of the right leg without any signs of dvt was noted, which was however regressive after lymph drainage.A implant preserving surgery was carried out on the (b)(6) 2011 due to an early stage infection.Debridement and placement of 30 septopal-chains was carried out.Blood transfusion for anema was noted.Enterococcus faecalis was identified and immediately treated with ampicillin.The revision surgery was ultimately carried out on the (b)(6) 2011 due to persistent infection and after the patient complained of a week of persistent wound secretion (wound dehiscence approx.2.0 to 3.0 cm).All metal components were explanted from the patient.The plate to support osteosynthesis was completely covered by pus.Debridement was carried out.Based on the available information and no x-rays being provided, the most likely root cause for the periprosthetic bone fracture is described in the primary surgical report dated (b)(6) 2011, whereby a window-osteotomy had to be carried out twice to remove the previous implant and cement, therefore leaving the femur at risk of fracturing.Site-description of the fracture in the surgical report dated (b)(6) 2011 confirm being around the location of the window-osteotomy.Based on the available information being provided, a definite root cause for the infection can not be confirmed as infection can have numerous root causes.Possible causes of infection include wrong handling of device due to wrong information, wrong re-sterilization procedures for sterile delivered parts or packaging failure during transportation.Enterococcus faecalis, which was identified commonly cause urinary tract infection (uti), to which the patient experienced.The patient additionally underwent a number of surgeries in a small time frame and during these surgeries almost always had to have a blood transfusion for anemia.The implanted trauma plate on the (b)(6) 2011 to support osteosynthesis after periprosthetic fracture are delivered to hospitals as un-sterile products.Therefore, it can not be concluded that the product was sterilized according to specification.The need for corrective measures is not indicated and zimmer gmbh considers this case as closed.Zimmer biomet's reference number of this file is (b)(4).The following reports are associated with this event: 0009613350-2019-00739-1, 0009613350-2019-00740-1, 0009613350-2019-00743-1, and 0009613350-2019-00726-1.

• Brand Name: BIOLOX DELTA, CERAMIC FEMORAL HEAD, L, ø 36/+3.5, TAPER 12/14
• Type of Device: BIOLOX DELTA, CERAMIC FEMORAL HEAD
• Manufacturer (Section D): ZIMMER GMBH; sulzer allee 8; sulzer industrie park; winterthur 8404 ; SZ 8404
• MDR Report Key: 9390173
• MDR Text Key: 168582063
• Report Number: 0009613350-2019-00745
• Device Sequence Number: 1
• Product Code: KXA
• UDI-Device Identifier: 00889024430372
• UDI-Public: 00889024430372
• Combination Product (y/n): N
• PMA/PMN Number: K071535
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,s
• Type of Report: Initial,Followup
• Report Date: 03/19/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/28/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: N/A
• Device Catalogue Number: 00-8775-036-03
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 03/18/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention