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Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Death (1802); No Code Available (3191)
Event Date 09/10/2019
Event Type  Death  
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 code(s) 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. Corrective action was not indicated. Report source is a literature article. There is limited information regarding the reported death. (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
The literature article entitled, "cemented proximal femoral replacement for the management of non-neoplastic conditions: a versatile implant but not without its risks" written by christopher fenelon, mb bch, mch, mrcsi, evelyn p. Murphy, mb bch, mch, mrcsi, stephen r. Kearns, mb bch, md, frcsi, william curtin, mb bch, frcsi, and colin g. Murphy, mb bch, bao, frcsi published by the journal of arthroplasty published online 10 september 2019 was reviewed. The article's purpose was to assess the reoperation, complication, and mortality rates following cemented proximal femoral replacement (pfr) for treatment of nonneoplastic conditions. Data was compiled from multi-surgeon observational study of patients treated with a pfr between january 1, 2018 and december 31, 2018 in galway university hospital (79 pfrs). Indication for pfr was mostly commonly for periprosthetic fractures and revision total hip arthroplasty (tha) but also were performed for hemiarthroplasties. Article reports 35 patients received acetabular revision but does not specify or identify products utilized indicating some original acetabular components were left intact or non-existent. All other original implants are unknown and not identified. Article reports pfr procedures utilized either depuy lps system (55) or a non-depuy system (24) for proximal femoral replacement. The article does not clarify which specific products are associated with the generalized adverse events. As the article does not identify any other components (acetabular or femoral head) or the existing acetabular components, only the proximal body and stem will be captured within this complaint for depuy lps. Cement manufacturer is not identified. Adverse events for those not identified are captured as generalized adverse events and accurate quantities cannot be determined due to inadequate information provided. The article examines deaths in the first 30-day period (table 3 with identified products and patient identifiers) and provided asa (american society of anesthesiologists) and bcis (bone cement implantation syndrome) grades as predictors of mortality. It is noted that all patients had an asa score of 3 or 4, and four of the patients had "extensive cardiopulmonary conditions" indicated by a bcis score of 3. The article also provides information for those who experienced dislocation (table 2 with identified products and patient identifiers) but does not identify acetabular or femoral head components. Figures 1-5 provide radiographic images of identified patients but no identification on brand name products utilized. The caption description does not indicate any adverse events associated with the pfr procedures. Depuy products: lps proximal body, lps femoral stem. Deaths from table 3: patient no 1, (b)(6) female diagnosed with comminuted proximal femoral fracture, asa grade 4, bmi 22, bcis grade 3 with lps implant, olsen predictors (chf, atrial fibrillation, beta blocker, ace inhibitor, and warfarin) died within 24 hours of operative day. Patient no 2, (b)(6) female diagnosed with periprosthetic fracture (original implants unknown) of vancouver b3 for uncemented tha 8 years in situ, asa grade 3, bmi 41, bcis grade 3 with lps implant, olsen predictors (chf, atrial fibrillation, bet blocker, ace inhibitor, diuretics) died within 24 hours of operative day. Patient no 5, (b)(6) female diagnosed with periprosthetic fracture (original implants unknown) of vancouver b3 for uncemented tha 5 years in situ, asa grade 3, bmi 22, bcis grade 3 with lps implant, olsen predictors (none listed) died 19 days postop. Generalized adverse events: venous thromboembolism (no indication of intervention), pulmonary embolus (no indication of intervention), deep venous thrombosis (no indication of intervention), prosthetic joint infection (successfully managed with long-term suppressive oral antibiotics, dislocations (treated by closed reductions, conservative management or revision of liner and femoral head).
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Manufacturer (Section D)
700 orthopaedic drive
warsaw IN 46581 0988
Manufacturer (Section G)
700 orthopaedic dr.
warsaw IN 46581 0988
Manufacturer Contact
kara ditty-bovard
700 orthopaedic drive
warsaw, IN 46581-0988
MDR Report Key10087847
Report Number1818910-2020-12530
Device Sequence Number1
Product Code KWY
Combination Product (y/n)N
Reporter Country CodeEI
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type foreign,health professional,l
Reporter Occupation Other Health Care Professional
Type of Report Initial
Report Date 05/13/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received05/26/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Catalogue NumberUNK HIP FEMORAL STEM
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 Received05/13/2020
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is the Device Single Use? No Answer Provided
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Outcome(s) Death; Required Intervention;