UNKNOWN ROTATING HINGE KNEE
Report
- Report Number
- 3002806535-2021-00066
- Event Type
- Injury
- Date Received
- March 1, 2021
- Report Date
- April 16, 2021
- Manufacturer
- BIOMET UK LTD.
- Product Code
- HRY
- PMA / PMN Number
- N/A
- Removal / Correction Number
- N/A
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- UK
- Reporter Occupation
- 501
Narratives
(B)(4). THIS FINAL REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. THE UK NATIONAL JOINT REGISTRY NOTIFIED ZIMMER BIOMET ON 19 FEBRUARY 2021 THAT THE ROTATING HINGE KNEE WITHOUT PATELLA RESURFACING (RHK) WAS IDENTIFIED AS A LEVEL 1 OUTLIER WHEN COMPARED TO ITS DEVICE GROUP. AT THE TIME OF THE NOTIFICATION, THERE WERE 185 RHK¿S AND 14 REVISIONS (7.6 PERCENT RAW REVISION RATE, PTIR = 1.26). CURRENTLY, THERE ARE 186 RHK¿S WITH 15 REVISIONS. SURVIVORSHIP IS 84.0 PERCENT AT 10 YEARS WITH A 1.3 PTIR. EXECUTIVE SUMMARY: THE ROTATING HINGE KNEE WITHOUT PATELLA RESURFACING (RHK) APPEARS TO HAVE A HIGHER REVISION RATE WHEN COMPARED TO THE GROUP PTIR. HOWEVER, THE GROUP PTIR SEEMS TO BE THAT OF BICONDYLAR KNEES WHEREAS IT SHOULD CONSIST OF HINGED KNEES. THE MAJORITY OF THE REVISIONS IN THE RHK¿S WERE DUE TO INFECTIONS (66.7 PERCENT). IN THE NOTIFICATION LETTER, THE COMPARISON GROUP PTIR WAS INDICATED AS 0.36. THIS COMPARATIVE GROUP PTIR APPEARS TO BE THAT OF BICONDYLAR KNEES AND NOT HINGED KNEES. AS INDICATED IN PMS_REPORT_KP_RHK_20-02-21.PDF, THE GROUP PTIR FOR HINGED KNEES IS 0.97. THIS PTIR IS COMPARABLE WITH THE CURRENT ESTIMATE OF 1.3 [95 PERCENT CI (0.73, 2.15)] FOR RHK CASES AND WOULD ELIMINATE IT AS AN OUTLIER. FOR EXAMPLE, A COMPARISON BETWEEN THE RHK AND PERSONA PS CASES FROM THE PMS_REPORT_KP_PERSONA_20-02-21.PDF REPORT INDICATE DIFFERING TYPES OF PATIENTS. IN RHK CASES, 36.4 PERCENT HAVE AN ASA GRADE P3 OR HIGHER WITH INCREASING SEVERITY AND NUMBER OF COMORBIDITIES; IN PERSONA PS CASES, THIS PERCENTAGE IS JUST 12.8 PERCENT. OSTEOARTHRITIS WAS OBSERVED IN 75.2 PERCENT OF RHK CASES AND 96.8 PERCENT IN PERSONA PS. THE RHK CASES ARE, ON AVERAGE, OLDER PATIENTS WITH ALMOST ONE THIRD BEING 80 YEARS OLD AND OLDER; 15.3 PERCENT OF PERSONA PS CASES ARE 80 OR OVER. THESE DIFFERENCES POINT TO A MORE CHALLENGING PATIENT POPULATION WITH HINGED KNEES. OVERALL, WHEN RHK IS COMPARED TO ALL OTHER HINGED KNEES IN THE NJR, THESE BASELINE OUTCOMES ARE ALIGNED AND COMPARABLE. ZIMMER BIOMET INTERNAL ANALYSIS OF UK NJR ON ROTATING HINGE KNEE WITHOUT PATELLA RESURFACING DATA PATIENT DEMOGRAPHICS SHOW THAT MOST PATIENT DEMOGRAPHICS WERE COMPARABLE BETWEEN RHK AND ALL OTHER HINGED CASES. THE ONLY NOTABLE OBSERVATION WAS 9.6 PERCENT OF RHK WERE ASA P1 GRADE WHILE 4.7 PERCENT OF THE OTHER HINGED CASES WERE ASA P1. NEXT, WE LOOKED AT MULTIPLE VARIABLES TO DETERMINE IF ANY WERE SIGNIFICANT IN PREDICTING THE HIGHER REVISION RATES. VARIABLES INCLUDED SIZE, SURGICAL APPROACH, YEAR OF SURGERY AND SURGICAL SITE. STANDARD FEMORAL IMPLANTS WERE REVISED 10.3 PERCENT OF THE TIME AND COCR TRAYS WERE REVISED 10.0 PERCENT OF THE TIME. AFTER CREATING AN INTERACTION TERM BETWEEN THESE TWO OUTCOMES, THE REVISION RATES WERE BETWEEN 8.9 PERCENT AND 10 PERCENT FOR STANDARD/STEMMED, STANDARD/COCR AND SMALL/COCR AND 4.5 PERCENT FOR SMALL/STEMMED CONSTRUCTS. FOURTEEN OF THE FIFTEEN REVISIONS WERE FOUND IN SURGERIES USING THE MEDIAL PARAPATELLAR APPROACH AND EVENLY DISTRIBUTED OVER THE YEARS. NEXT, REVISION RATES BY SITE WERE ASSESSED; THE THREE LARGEST SITES WERE 4295 WITH 53 CASES, 4282 WITH 15 CASES, AND 4327 WITH 13 CASES IN WHICH TOGETHER REPORTED A TOTAL OF FIVE REVISIONS. INFECTION WAS THE MAIN REASON FOR REVISION WHICH ACCOUNTED FOR 10 OF THE 15 REVISIONS (66.7 PERCENT). ADDITIONALLY, THE SURVIVAL ESTIMATE MAY APPEAR TO BE LOWER AS 33.9 PERCENT (63/186) OF THE RHK CASES HAVE EXPIRED TO DATE. THIS MAY BE LARGELY DUE TO THE PREVIOUSLY NOTED OLDER PATIENT POPULATION AND HIGHER ASA CLASS WITH MORE SEVERE AND SYSTEMIC COMORBIDITIES. BY COMPARING RHK TO OTHER HINGED KNEES, RHK IS PERFORMING WITHIN EXPECTED LIMITS AND DOESN¿T APPEAR AS AN OUTLIER. BASED ON OUR ANALYSIS NO FURTHER ACTION IS NEEDED AND COMPLAINTS RECEIVED FOR ROTATING HINGE KNEE WILL CONTINUE TO BE MONITORED AS PART OF OUR ONGOING PMS PROCESS AS IT APPEARS THE PTIR IS IN LINE WITH THE CURRENT ESTIMATE OF 1.3 [95 PERCENT CI (0.73, 2.15)] FOR RHK CASES. AT 10 YEARS WITH A 1.3 PTIR.
IT WAS REPORTED THAT FOLLOWING A REVIEW OF THE DATA CONDUCTED IN SEPTEMBER 2020, THE NATIONAL JOINT REGISTRY (NJR) IDENTIFIED THAT THE ROTATING HINGE KNEE (RHK) WITHOUT PRIMARY PATELLA RESURFACING APPEARS TO HAVE A PATIENT TIME INCIDENCE RATE (PTIR) INCLUDING CONFIDENCE INTERVALS TWICE THAT OF ITS DEVICE GROUP. NJR IDENTIFIED 16 REVISIONS FOR THE RHK. THIS COMPLAINT REPORTS THE 16 REVISIONS FOR THE RHK DUE TO UNKNOWN REASONS.
(B)(4). INITIAL REPORT. REPORT SOURCE, FOREIGN - EVENT OCCURRED IN (B)(6). DEVICE AVAILABLE FOR EVALUATION: CUSTOMER HAS INDICATED THAT THE PRODUCT WILL NOT BE RETURNED TO ZIMMER BIOMET FOR INVESTIGATION (PRODUCT LOCATION IS UNKNOWN). POSTAL CODE: (B)(6). THE INVESTIGATION IS IN PROCESS. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A FOLLOW-UP MDR WILL BE SUBMITTED. PRODUCT HAS NOT BEEN RETURNED.
IT WAS REPORTED THAT FOLLOWING A REVIEW OF THE DATA CONDUCTED IN (B)(6) 2020, THE (B)(6) REGISTRY ((B)(6)) IDENTIFIED THAT THE ROTATING HINGE KNEE (RHK) WITHOUT PRIMARY PATELLA RESURFACING APPEARS TO HAVE A PATIENT TIME INCIDENCE RATE (PTIR) INCLUDING CONFIDENCE INTERVALS TWICE THAT OF ITS DEVICE GROUP. (B)(6) IDENTIFIED 16 REVISIONS FOR THE RHK. THIS COMPLAINT REPORTS THE 16 REVISIONS FOR THE RHK DUE TO UNKNOWN REASONS.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 292709 | UNKNOWN ROTATING HINGE KNEE | UNKNOWN KNEE ARTHROPLASTY | HRY | BIOMET UK LTD. | N/A | UNK |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Hospitalization| R |