UNK CEMENT RESTRICTOR/PLUG

Additional Manufacturer Narrative

PRODUCT COMPLAINT # (B)(4). THIS REPORT IS BEING SUBMITTED PURSUANT TO THE PROVISIONS OF 21 CFR, PART 803. THIS REPORT MAY BE BASED ON INFORMATION WHICH HAS NOT BEEN INVESTIGATED OR VERIFIED PRIOR TO THE REQUIRED REPORTING DATE. THIS REPORT DOES NOT REFLECT A CONCLUSION BY DEPUY SYNTHES JOINT RECONSTRUCTION, OR ITS EMPLOYEES THAT THE REPORT CONSTITUTES AN ADMISSION THAT THE PRODUCT, DEPUY SYNTHES JOINT RECONSTRUCTION, OR ITS EMPLOYEES CAUSED OR CONTRIBUTED TO THE POTENTIAL EVENT DESCRIBED IN THIS REPORT. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL REPORT, A FOLLOW-UP REPORT WILL BE FILED AS APPROPRIATE.

Additional 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. INVESTIGATION SUMMARY: NO DEVICE ASSOCIATED WITH THIS REPORT WAS RECEIVED FOR EXAMINATION. A WORLDWIDE LOT SPECIFIC COMPLAINT DATABASE SEARCH, OR MANUFACTURING RECORD EVALUATION, WAS NOT POSSIBLE AS THE REQUIRED LOT NUMBER WAS NOT PROVIDED. THE INFORMATION RECEIVED WILL BE RETAINED FOR TREND ANALYSIS, POST MARKET SURVEILLANCE, OR OTHER EVENTS WITHIN THE QUALITY SYSTEM.

Description of Event or Problem

THIS COMPLAINT IS FROM A LITERATURE SOURCE. THE FOLLOWING LITERATURE CITE HAS BEEN REVIEWED: BAKER RP, SQUIRES B, GARGAN MF, BANNISTER GC. TOTAL HIP ARTHROPLASTY AND HEMIARTHROPLASTY IN MOBILE, INDEPENDENT PATIENTS WITH A DISPLACED INTRACAPSULAR FRACTURE OF THE FEMORAL NECK. A RANDOMIZED, CONTROLLED TRIAL. J BONE JOINT SURG AM. 2006 DEC;88(12):2583-9. DOI: 10.2106/JBJS.E.01373. PMID: 17142407. OBJECTIVE AND METHODS: HEMIARTHROPLASTY AND TOTAL HIP ARTHROPLASTY ARE COMMONLY USED TO TREAT DISPLACED INTRACAPSULAR FRACTURES OF THE FEMORAL NECK, BUT EACH HAS DISADVANTAGES, AND THE OPTIMAL TREATMENT OF THESE FRACTURES REMAINS CONTROVERSIAL. IN THE PRESENT PROSPECTIVELY RANDOMIZED STUDY, EIGHTY-ONE PATIENTS WHO HAD BEEN MOBILE AND LIVED INDEPENDENTLY BEFORE THEY HAD SUSTAINED A DISPLACED FRACTURE OF THE FEMORAL NECK WERE RANDOMIZED TO RECEIVE EITHER A TOTAL HIP ARTHROPLASTY OR A HEMIARTHROPLASTY. THE MEAN AGE OF THE PATIENTS WAS SEVENTY-FIVE YEARS. PATIENTS WERE EVALUATED AT THREE MONTHS, ONE YEAR, AND THREE YEARS AFTER SURGERY. THE PATIENTS WERE DIVIDED INTO TWO GROUPS: 41 IN THE HEMIARTHROPLASTY GROUP AND 40 IN THE THA GROUP. THE COMPETITOR FEMORAL STEMS IN BOTH GROUPS WERE SECURED WITH COMPETITOR CEMENT UTILIZING A DEPUY HARDINGE CEMENT RESTRICTOR AND PAIRED WITH A COMPETITOR FEMORAL HEAD. THE ACETABULAR COMPONENTS UTILIZED IN THE THA GROUP WERE COMPETITOR PRODUCTS AS WELL. INITIAL POSTOPERATIVE RADIOGRAPHS WERE REVIEWED TO DETERMINE CEMENT GRADE AND FEMORAL ALIGNMENT. FINAL RADIOGRAPHS WERE ANALYZED TO DETERMINE MIGRATION AND FEMORAL STEM SUBSIDENCE. THIS COMPLAINT WILL CAPTURE ALL EVENTS ASSOCIATED WITH THE DEPUY DEVICES. RESULTS ASSOCIATED WITH THE COMPETITOR IMPLANTS WILL BE EXCLUDED. LOT, MODEL AND CATALOG NUMBER ARE NOT AVAILABLE, BUT THE SUSPECTED DEPUY DEVICE POSSIBLY ASSOCIATED WITH REPORTED ADVERSE EVENTS: HARDINGE CEMENT RESTRICTOR ADVERSE EVENT(S) AND PROVIDED INTERVENTIONS ASSOCIATED WITH DEPUY DEVICES: DEATHS: 2 DEATHS IN THE IMMEDIATE POSTOPERATIVE PERIOD SECONDARY TO PULMONARY EMBOLISMS. ADVERSE EVENTS: 4 POST-OPERATIVE WOUND INFECTIONS-1 TREATED WITH SURGICAL DEBRIDEMENT 1 REPORT OF NON-FATAL PULMONARY EMBOLISM- TREATMENT NOT SPECIFIED. 4 POSTOPERATIVE DVTS- TREATMENT NOT SPECIFIED 1 REPORT OF ATRIAL FIBRILLATION- TREATMENT NOT SPECIFIED 1 REPORT OF HEMATEMESIS- TREATMENT NOT SPECIFIED 5 REPORTS OF PNEUMONIA- TREATMENT NOT SPECIFIED 1 FEMORAL REVISION TO TREAT PAIN SECONDARY TO MASSIVE (18 MM) SUBSIDENCE RADIOGRAPHIC RESULTS: THE MEAN STEM SUBSIDENCE (IMPLANT TO CEMENT INTERFACE) AFTER THREE YEARS WAS 1.94 MM IN THA AND 1.74 IN HEMI. NO PATIENT CONSEQUENCES OR TREATMENT REQUIRED.