MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH RESTORATION ADM X3 INS 28/52; PROSTHESIS, HIP, SEMI-CONSTRAINED, UNCEMENTED, METAL/POLYMER, NON-POROUS, CALICU

Model Number 1236-2-852

Device Problem Insufficient Information (3190)

Patient Problem Bacterial Infection (1735)

Event Date 11/29/2016

Event Type  Injury  

Manufacturer Narrative

Reported event: an event regarding infection involving a adm liner was reported.The event was not confirmed.Method & results: product evaluation and results: material analysis, visual, functional and dimensional inspections could not be performed as the device was not returned.Clinician review: no medical records were received for review with a clinical consultant.Product history review: a review of the device manufacturing records indicate that all devices accepted into final stock were free from discrepancies.Complaint history review: there have been no other similar events for the lot referenced.There have been no other similar events for the sterile lot referenced.Conclusions: all stryker products sold as sterile are validated to a minimum sterility assurance level sal of 10^-6 in accordance to applicable iso standards.The exact cause of the event could not be determined because insufficient information was provided.Further information such as return of the device, pathology reports, pre- and post-operative x-rays and the primary operative report as well as patient history and follow-up notes are needed to complete the investigation for determining root cause.No further investigation for this event is possible at this time.If devices and / or additional information become available to indicate further evaluation is warranted, this record will be reopened.

Event Description

This pi is for surgery performed (b)(6) 2016: ".Highlighted the positivity to (b)(6) and, therefore, recommended a surgical revision of the wound and fistulectomy, which was performed." the lawyer of the patient reported that on (b)(6) 2016, the patient underwent a total prosthesis surgery of the right hip.The patient went to the hospital on (b)(6)2016, due to severe pain in the right hip caused by a right coxarthrosis, for which the doctors who visited her recommended surgery for the "prosthetic replacement of the hip" during the hospital stay, after the first surgery, then several episodes of dislocation of the recently implanted prosthesis, for which the patient, on (b)(6) 2016, underwent a new reduction operation, by the surgeons, and was then discharged on (b)(6) 2016.Four days after the discharge occurred a new episode of dislocation, as a result of which she was once again hospitalized and, on (b)(6) 2016, subjected to a new revision surgery of the hip prosthesis, with "repositioning of the acetabular component of the implant", and then discharged on (b)(6) 2016, with the diagnosis of "dislocation resulting in right hip prosthesis.Allergic history, anemia.Surgical wound dehiscence.Local antibiotic therapy ".On (b)(6) 2016, the patient was transferred to a rehabilitation facility with diagnosis of entry: "right hip surgery.Sacral decubitus lesion, right hip surgical wound with punishment material" where they practiced muscle strengthening exercises in the lower limbs, strengthening the right quadriceps, static load exercises and rehabilitation in step and walking autonomous."in addition, at the facility, given the spill of purulent material from the surgical wound, it was necessary to perform blood-borne examinations and a swab of the wound that showed "positivity for a (b)(6) bacterium".On (b)(6) 2016, a new episode of prosthetic dislocation occurred for which the patient, following a report by the doctors of the rehabilitation facility of, was transferred to hospital and the following day underwent a reduction surgery again.Given the umpteenth episode of dislocation, therefore, the patient decided to turn to another orthopedic specialist, who, on (b)(6) 2016, diagnosed her: " right hip prosthesis revision surgery for relapsing dislocation (5 episodes) ", moreover, given the persistence of the infection, he prescribed an additional swab that highlighted the positivity to (b)(6) and, therefore, recommended a surgical revision of the wound and fistulectomy, which was performed on (b)(6) 2016.Further checks followed by doctor for the treatment of the infection which, however, was not eradicated.Still, the patient also turned to another orthopedic specialist, who, evaluating the conditions of the fistula on the right hip infected and always secreting purulent material, recommended an infectious disease consultation with a specialist in infectious diseases, which the applicant performed on (b)(6) 2017.The said infectious disease, after having diagnosed her with a: "delayed infection of total right hip prosthesis at the moment with secreting fistula", he prescribed blood tests, in addition to proposing a two-stage therapy, with removal of the prosthesis, with placement of an antibiotic spacer for reclamation of the outbreak of infection, and this until, on (b)(6) 2017, due to a new episode of dislocation of the right hip, the patient was urgently accompanied to the hospital, where she underwent to a new reduction intervention.It should also be noted that on (b)(6) 2018 the applicant made a new visit to the hospital which ascertained the closure of the secreting fistula, interrupted the therapy and prescribed follow up with repetition of the blood tests (ves and per) for monitoring and possible resumption of latent infection.

• Brand Name: RESTORATION ADM X3 INS 28/52
• Type of Device: PROSTHESIS, HIP, SEMI-CONSTRAINED, UNCEMENTED, METAL/POLYMER, NON-POROUS, CALICU
• Manufacturer (Section D): STRYKER ORTHOPAEDICS-MAHWAH; 325 corporate drive; mahwah NJ 07430
• Manufacturer (Section G): STRYKER ORTHOPAEDICS-CORK; ida industrial estate; carrigtwohill NA ; EI NA
• Manufacturer Contact: alessandra chavez ; 2555 davie road; fort lauderdale, FL 33317 ; 9546280700
• MDR Report Key: 10860946
• MDR Text Key: 218529719
• Report Number: 0002249697-2020-02487
• Device Sequence Number: 1
• Product Code: MEH
• UDI-Device Identifier: 04546540638991
• UDI-Public: 04546540638991
• Combination Product (y/n): N
• Reporter Country Code: IT
• PMA/PMN Number: K093644
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 11/18/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/18/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 02/28/2021
• Device Model Number: 1236-2-852
• Device Catalogue Number: 1236-2-852
• Device Lot Number: 54846601
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 10/25/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/18/2016
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention