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Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problem Renal Failure (2041)
Event Date 03/12/2013
Event Type  Injury  
Manufacturer Narrative
Product complaint # (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 received entitled "outcomes of primary total joint arthroplasty after lung transplantation". Literature article entitled, ¿outcomes of primary total joint arthroplasty after lung transplantation¿ by cameron k. Ledford, md, et al, published by the journal of arthroplasty (2014), vol. 29, pp. 11-15 was reviewed for mdr reportability. Outcomes of 20 primary total joint arthroplasties (15 tha, 5 tka) in 14 patients with lung transplantation were reviewed. Clinical follow-up time averaged 27. 5 and 42. 8 months for tha and tka respectively. Arthroplasty indications included osteonecrosis, osteoarthritis, and fracture. All patients subjectively reported good or excellent outcomes with a final average harris hip score of 88. 7, knee society objective and functional score of 92. 0. There were 4 minor and 1 major acute perioperative complication. 1 late tka infection was successfully treated with two-stage revision. The mortality rate was 28. 5% (4/14 patients) at an average 20. 6 months following but unrelated to arthroplasty. Overall, total joint arthroplasty can be safely performed and provide good functional outcomes in lung transplant recipients. This study retrospectively reviewed all patients who underwent primary total joint arthroplasty (tja) following bilateral orthotopic lung transplantation at duke university medical center between 2006 and 2012. 20 total joint arthroplasties in 14 pulmonary transplant recipients were identified through an internal surgical database search for both the icd-9 code v42. 6 (lung replaced by transplant) and the current procedural terminology code 27130 (tha) or 27447 (tka). Patients were excluded if b18 years old, did not have lung transplant prior to arthroplasty, failed or received n1 lung transplant, or received additional or separate solid organ transplant. Clinical follow-up was obtained through a retrospective chart review of patient demographics, pre-operative and post-operative multi-disciplinary physician clinical notes (pulmonary transplant, anesthesia, and adult reconstruction), operative reports, discharge summaries, and clinical exams. All patients received preoperative prophylaxis antibiotics, were skin prepped with chloraprep and chlorhexidine pre-prep, and all except one patient received dvt post-op prophylaxis with lovenox and scds. Fifteen primary thas were performed in 10 patients with previous lung transplantation including 5 females and 5 males. All acetabular components were uncemented depuy pinnacle (warsaw, in) hemispherical cups ranging in size from 50 to 56. Femoral stems were also uncemented in all procedures and included 12 depuy summit and 3 depuy corail (warsaw, in). Femoral heads ranged from size 32 to 36. Average estimated blood loss was 353 (150¿700) ml with no reported intra-operative complications. The hospital course was complicated in 4 hips including electrolyte imbalances (2 patients), acute renal insufficiency (1 patient) resolving with medical management, and colonic perforation (1 patient) resulting in emergent sigmoid resection with placement of a colostomy (fig. 1). Blood transfusion for clinically symptomatic anemia (defined by hematocrit b25 l/l and signs of anemia including tachycardia, orthostasis, or light-headedness) was performed after 10 procedures with an average of 1. 9 (1¿4) units given. Length of stay was 4. 1 (2¿16) days with final disposition of 12 hips returning to home and 3 hips needing extended care (skilled nursing or acute rehabilitation facilities). Postoperative clinical follow-up was available at an average of 27. 5 (2¿56) months in all but one patient who died of respiratory complications before standard clinical follow-up could be obtained. There were no periprosthetic infections or revision surgeries performed. Mortality, as defined by documented death or imminent death after hospice placement, was found in 3 patients (4 hips) from respiratory failure at approximately 23 (10¿37) months following tha and 43 (14¿61)months total from time of transplant. Five primary tkas were performed in 4 patients after lung transplantation (table 2) including 3 females and 1 male. Indications for lung transplant were pulmonary fibrosis (3 patients) and pulmonary hypertension (1 patient) at an average age of transplant of 58. 0 (50¿66) years old. Interval between transplant and arthroplasty was 46. 8 (29¿81) months. Comorbidities in this cohort were similar including pulmonary compromise (all 4 patients), hypertension (3 patients), chronic kidney disease (2 patients), diabetes mellitus (2 patients), and coronary artery disease (1 patient). Total knee arthroplasty was performed using a standard medial parapatellar approach with cement fixation and patellar resurfacing in all patients. The zimmer natural knee (warsaw, in) was used in patient #1 while all other patients received the depuy pfc sigma (warsaw, in). Tourniquet time ranged from 92 to 119 min and estimated blood loss averaged 120 (50¿300) ml. In patient #1, an intraoperative femoral-sided mcl-sleeve avulsion occurred that was directly repaired with suture and the patient placed in a hinged knee brace postoperatively. One hospital-related complication reported was thrombocytopenia resulting in discontinuing the institution¿s standard pharmaceutical anticoagulation and being discharged with mechanical prophylaxis for home use. Blood transfusion was performed after 4/5 tkas with an average of 2. 5 (2¿4) units given. Length of stay was 3. 6 (3¿6) days with 3 patients returning home and 2 requiring an extended care facility. Postoperative clinical follow-up was available in all 5 knees at an average of 42. 8 (17¿63) months. Patients reported their outcomes as good (3 knees) or excellent (2 knees). One knee (patient #4 left) became infected 32 months after index procedure and required a 2-stage revision. Despite the additional revision surgery, the patient still reported excellent outcomes. Finally, one tka patient died 23 months following her joint procedure from decompensated respiratory failure. The transfusion rate in this series was relatively high with 10/15 hips (66%) and 4/5 knees (80%) receiving a blood transfusion for symptomatic anemia. There was only one case of periprosthetic infection in a tka patient who experienced an acute infection 18 months after the index procedure with coagulase negative staphylococcus. The source was presumed to be hematogenous and the patient was treated initially with irrigation, debridement and polyethylene liner exchange followed by an extended course of intravenous antibiotics. However, his infection recurred, and he later underwent successful treatment with a two-stage revision with excellent outcomes. Mortality at time of final follow-up was also seemingly high including 4 of 14 patients (4 hips, 1 knee). The interval time of transplant and time of arthroplasty to death averaged 50. 2 and 20. 6 months respectively. Current unadjusted median survival rates following pulmonary transplant are estimated to be 79% at 1 year, 64% at 3 years, 53% at 5 years, and 30% at 10 years with certain degrees of variation according to baseline patient demographics, comorbidities, and condition of donor lungs. Our patient survival rate of 71. 8% (10/14 patients) at a median follow-up of 30. 5 months (2. 5 years) appears to be comparable to these results. While it is difficult to make specific conclusions based upon this small patient cohort, the reality of shortened life expectancy must be discussed with individual lung transplant patients prior to performing elective joint arthroplasty. This pc will have 2 pcs including the parent pc labeled case 1-2. Case 2 is an unknown knee, the other 1 is unknown hip implants. The transfusions listed within this text were related to symptomatic anemia and are unrelated to the implants. The deaths that occurred in this study are a result of the patient¿s comorbidities related to lung transplant surgery and are not a result of implanted products. Case 1 patient # 9. Indications for right tha: avascular necrosis 27 months after lung transplantation. Implanted with pinnacle cup, unk femoral head, and unknown deput femoral stem. Patient had perioperative complication of acute renal insufficiency requiring medical intervention. No product problems or revisions.
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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 Key9087080
MDR Text Key163573128
Report Number1818910-2019-105103
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
Report Date 08/30/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received09/19/2019
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
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 Received08/30/2019
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: 09/19/2019 Patient Sequence Number: 1