MAUDE Adverse Event Report: SMITH & NEPHEW ORTHOPAEDICS AG UNKN. BICON-PLUS SHELL; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, CEMENTED

Catalog Number UNKNOWN

Device Problems Entrapment of Device (1212); Difficult to Remove (1528)

Patient Problems Failure of Implant (1924); Sepsis (2067); Shock (2072)

Event Date 01/04/2021

Event Type  Death  

Manufacturer Narrative

(b)(4).

Event Description

It was reported that, during a revision surgery to treat a septic infection, the bicon cup could not be easily removed: the unscrewing instrument of the bicon cup did not grip, which is why the cup could not be taken out as planned: it had to be cut around with gooseneck chisels, which allowed the cup to be removed.This contributed to surgical delay.The patient developed severe haemodynamic shock intraoperatively: partly septic (because of the infection), and partly because of the duration of the surgery (blood loss).This resulted in multi-organ dysfunction with anuric kidney failure, hepatopathy, increasing hyperlactatemia and increasing circulatory instability, which led to patient's death next day.Although the patient did not have any s&n prosthesis at the time of death, it is believed that one of reasons that might have contributed to patient's outcome was the delayed surgery caused by the difficulty in cup removal.

Manufacturer Narrative

H3, h6: it was reported that an explantation surgery of a size 4 bicon cup took place in winterthur on (b)(6) 2021.The report sent by the hospital to the swiss nca as well as the surgery reports indicate that a haemodynamic shock developed due to sepsis and blood loss from which the patient ultimately died the day following the surgery.During this surgery the surgeon did not succeed in removing the cup using the available bicon instruments.The cup was instead extracted using a chisel.This caused a bone defect which required a reconstruction.The instruments used in the treatment have been provided for investigation.These instruments were tested according to the relevant inspection instructions.A further functional test was performed with new implants obtained from stock.No functional issues that could explain the unsuccessful attempt to remove the cup were detected.Furthermore available data shows that the instruments used for the extraction of the cup were used at least 9 times since 2012.No malfunctions were reported during these previous surgeries.There is therefore no indication that these instruments either failed to match specification upon release for distribution or failed to perform as expected during surgery.A bicon cup size 4 and the pe insert part n°75101935 batch a1903452 were returned for investigation.These devices were used in treatment.The batch number of the cup is not readable due to the presence of bone.The amount of bone visible on the bicon cup demonstrates that is was well osseointegrated.A crack is visible from the corner of one slot down to the floor of the cup.No detail analysis of the crack is possible without destructive methods.The origin of the crack remains unclear.A drill hole is visible on the edge of the pe insert.Such a hole is typical of the use of a screw in order to remove the insert operatively.A matching dent is visible on the floor of the cup.The severity and occurence of the reported failure mode (implant requiring of a chisel to be explanted leading to a surgery extension of up to 30 minutes) are covered in the risk file.Operation of a very critical patient with multiple comorbidities including sepsis is a general surgical risk that is not in the scope of the device risk file.Available instruction for use indicates that in case of a well osseointegrated screw cup the use of an ancillary chisel is expected and a normal part of the explantation procedure.Furthermore infection is listed among the contra-indications in the instruction for use lit.No.12.23 ed.05/16.The reports provided by the hospital indicate that a haemodynamic shock developed due to sepsis and blood loss from which the patient ultimately died.Our investigation shows that the initial difficulty to explant the cup led to a surgery extension of 15 to 20 minutes which is standard for such revision and not considered a delay to the expected duration of this type of surgery.The very unfortunate death of the patient, appears to be a result of the comorbidities reported during the multiple previous procedures and finally of a complicated revision of his septic hip and resulting blood loss.The source of the sepsis cannot be confirmed but the subject had multiple procedures that occurred over the prior 5 months performed after a fall and resulting periprosthetic fracture 20 years after the initial implant of the s+n components.Based on the investigation performed no further actions have been initiated.No direct causal relationship between the failed initial attempt to remove the cup and the death of the patient can be identified.Smith and nephew will monitor these devices for further issues.The returned devices will be retained.

• Brand Name: UNKN. BICON-PLUS SHELL
• Type of Device: PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, CEMENTED
• Manufacturer (Section D): SMITH & NEPHEW ORTHOPAEDICS AG; schachenallee 29; aarau CH-50 00; SZ CH-5000
• MDR Report Key: 11240210
• MDR Text Key: 229073793
• Report Number: 9613369-2021-00056
• Device Sequence Number: 1
• Product Code: JDI
• Combination Product (y/n): N
• PMA/PMN Number: UNKNOWN
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,consum
• Type of Report: Initial,Followup
• Report Date: 05/29/2021

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
• Device Operator: Health Professional
• Device Catalogue Number: UNKNOWN
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: 01/06/2021
• Initial Date FDA Received: 01/27/2021
• Supplement Dates Manufacturer Received: 05/28/2021
• Supplement Dates FDA Received: 05/29/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Death; Hospitalization; Required Intervention
• Patient Age: 70 YR
• Patient Weight: 115