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Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Wound Dehiscence (1154); Unspecified Infection (1930); Pain (1994); Limited Mobility Of The Implanted Joint (2671); No Code Available (3191)
Event Date 12/29/2015
Event Type  Injury  
Manufacturer Narrative
(b)(4). If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate. (b)(4).
Event Description
"literature article entitled, ¿prosthetic hip infection with edwardsiella tarda in sickle cell beta thalassemia disease: a case report¿ by david b. Frumberg, md, et al, published by journal of clinical orthopaedics and trauma (2016), vol. 7s, pp. 130-133, was reviewed for mdr reportability. The authors report a previously unrecognized gram-negative bacillus as the infecting agent in a patient with bilateral total hip arthroplasties for stage iv osteonecrosis. A (b)(6) year-old male with combined sickle cell disease and beta thalassemia with a prior history of unknown hip surgeries and treatment for distal tibial osteomyelitis in africa developed a periprosthetic joint infection; intra-operative cultures confirmed the infecting organism to be edwardsiella tarda which was sensitive to late-generation cephalosporins and vancomycin. He was successfully treated with a staged revision total hip arthroplasty with an antibiotic spacer and has been infection-free since. The patient he underwent a right tha with a cementless modular stem, ceramic-on-ceramic bearing, and cementless cup (s-rom modular implant with a duraloc acetabular cup, depuy). During seating of the metaphyseal sleeve, an incomplete calcar fracture at the level of the lesser trochanter was discovered and fixed with two cerclage cables. Perioperative course was otherwise uneventful. Two months post-operatively, he had a sickle cell crisis which was conservatively managed. At his four-month postoperative clinic visit, a superficial wound dehiscence was observed which was treated aggressively with 1 week of iv vancomycin and oral amoxicillin. His dehiscence closed but an area of subcutaneous abscess emerged, from which purulent material was aspirated. He was indicated for surgical exploration and debridement of the wound. During surgery, purulent drainage was noted from a sinus in the fascia lata, but the short external rotators and hip joint capsule were intact. Intraoperative cultures were negative. Per infectious disease recommendations, he was discharged on a two-week course of oral amoxicillin/clavulanic acid. After 4 weeks, he reported increased pain and wound drainage and was indicated for irrigation and debridement. During surgery, the fascial sinus was observed to communicate with the hip joint. The acetabular component was well fixed, but the femoral component was loose. The stem and sleeve were removed and an antibiotic cement spacer with 6gm of vancomycin and 7. 2gm of tobramycin was placed (competitor product). After 3 weeks of aggressive antibiotic treatment, he was then indicated for second-stage reimplantation. He underwent irrigation and debridement, removal of cement spacer, and revision tha with a cementless modular femoral stem, ceramic-on-polyethylene bearing, and a cementless acetabular component (competitor products). The acetabular components and femoral head were explanted due to infection. There was no reported product problem with the components. The authors note that patients who have sickle cell crisis and iron overload are highly susceptible to the infectious organism e. Tarda. They further note that this was the first known, reported case of e. Tarda periprosthetic infection. Captured in this complaint: s-rom stem and sleeve for implant loosening and infection, duraloc cup and locking ring, ceramic head, and ceramic liner for infection. The femoral head and acetabular components had no reported product deficiencies. During the index tha, the patient had no discernable femoral canal and the surgeons had to perform extensive reaming to insert the stem and sleeve causing the intraoperative calcar fracture. ".
Manufacturer Narrative
Product complaint # (b)(4). Investigation summary
> no device associated with this report was received for examination. A worldwide lot specific complaint database search, or device history record (dhr) review, was not possible because the required lot number was not provided. Based on previous investigations, this complication of joint replacement is unlikely to have been the result of a device failing to meet required specifications. The information received will be retained for potential series investigations if triggered by trend analysis, post market surveillance, or other events within the quality system. Per internal procedures, the event information and any investigational inputs received as part of required follow up were reviewed. For this investigation, no immediate action was required as no alleged deficiency with the device was identified. Monitor ¿ exempt per (b)(4) - known possible complication of joint replacement surgery. No device associated with this report was received for examination. A worldwide lot specific complaint database search, or device history record (dhr) review, was not possible because the required lot number was not provided. The reported event is considered one of the possible complications of joint replacement. The complaint information provided has been reviewed for complaint coding, medical device reporting, and other data required by the complaint system. Follow-up for additional event information, if applicable, was conducted utilizing work instruction (b)(4) appendix a. Visual examination of the provided x-ray images found no evidence of implant fracture, disassociation, or anything indicative of a device non-conformance. Without the physical complaint sample associated with this report, it was not possible to determine if the device failed to meet specifications at the time it was released for distribution. The device associated with this event was used in the treatment of the patient as prescribed by the presiding surgeon. From the event information received, it was not possible to determine the relationship of the device to the reported event. No evidence was found indicating product error was a contributing factor. The need for corrective action was not indicated. Depuy considers the investigation closed. Should additional info be received, the investigation will be re-opened as necessary.
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Manufacturer (Section D)
700 orthopaedic drive
warsaw IN 46581 0988
Manufacturer (Section G)
700 orthopaedic drive
warsaw IN 46582
Manufacturer Contact
kara ditty-bovard
700 orthopaedic drive
warsaw, IN 46581-0988
MDR Report Key9216677
MDR Text Key163118488
Report Number1818910-2019-109512
Device Sequence Number1
Product Code KWY
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type literature
Reporter Occupation Other Health Care Professional
Type of Report Initial,Followup
Report Date 10/01/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received10/21/2019
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Catalogue NumberUNK HIP FEMORAL HEAD
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received11/12/2019
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Patient Treatment Data
Date Received: 10/21/2019 Patient Sequence Number: 1