COCR HEAD
Report
- Report Number
- 0009613350-2017-00920
- Event Type
- Injury
- Date Received
- July 3, 2017
- Date of Event
- December 18, 2012
- Report Date
- December 22, 2017
- Manufacturer
- ZIMMER GMBH
- Product Code
- JDI
- PMA / PMN Number
- PN/A
- Removal / Correction Number
- N/A
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- FR
- Reporter Occupation
- HEALTH PROFESSIONAL
Narratives
AS THE CASE AT HAND IS A LEGAL CLAIM IT IS NOT SUSPECTED THAT THE DEVICES OR ADDITIONAL INFORMATION ARE BEING SUBMITTED FOR REVIEW. ZIMMER GMBH WINTERTHUR LEGAL DEPARTMENT HAVE ALREADY PASSED ALL INFORMATION THAT WAS RECEIVED FROM THE LAWYER, TO OUR COMPLAINT HANDLING DEPARTMENT. BY EXPERIENCE ZIMMER GMBH NEVER GETS MORE INFORMATION EXCEPT FOR THE ONE THAT HAS BEEN ALREADY COVERED IN THE FINAL REPORT. PATIENTS¿ ADVOCATES ONLY PROVIDE TO ZIMMER GMBH AS MUCH INFORMATION AS THEY ARE WILLING TO SHARE TO PROTECT THE RIGHTS OF THEIR CLIENTS. ALL INFORMATION WHICH HAS BEEN PROVIDED FOR THIS PARTICULAR CASE IS ALREADY COVERED IN THE FINAL REPORT. NEVERTHELESS, SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE TO US, A FOLLOW UP REPORT WILL BE SUBMITTED. A TECHNICAL INVESTIGATION WAS NOT POSSIBLE TO BE PERFORMED, AS THE DEVICES WERE NOT AT HAND FOR INVESTIGATION. HOWEVER, BASED ON THE AVAILABLE INFORMATION THE INVESTIGATION IS CONDUCTED WITH OUTCOME AS FOLLOWS. TREND ANALYSIS: NO TREND ANALYSIS FOR THE COCR HEAD COULD BE PERFORMED AS THE CATALOGUE NUMBER IS UNKNOWN. AS NO LOT NUMBERS WERE PROVIDED FOR THE COCR HEAD, THE DEVICE HISTORY RECORDS COULD NOT BE REVIEWED. AT ZIMMER (B)(4) ALL MEDICAL DEVICES PRIOR RELEASE TO MARKET UNDERGO SEVERAL QUALITY INSPECTIONS AS DEFINED IN OUR QUALITY PROCEDURES. OUR QUALITY INSPECTION- AND DEVIATION PROCEDURES ENSURE THAT ONLY PRODUCTS FULFILLING THE SPECIFICATION ARE SOLD. THESE PROCEDURES ARE PART OF THE OVERALL QUALITY MANAGEMENT SYSTEM AT ZIMMER GMBH AND GET REGULARLY AUDITED BY OUR NOTIFIED BODY, COMPETENT AUTHORITIES AND INTERNAL AND EXTERNAL AUDITORS. THUS, FOR ALL PRODUCTS SOLD TO THE MARKET CAN BE ASSUMED HAVING A COMPLETE AND CORRECT DHR. EVENT DESCRIPTION (EVENT DETAILS, PER): EVENT SUMMARY: IT WAS REPORTED THAT PATIENT UNDERWENT THA WITH DUROM - AVENIR STEM IMPLANTED ON (B)(6) 2005. SUBSEQUENTLY, PATIENT UNDERWENT FIRST REVISION ON (B)(6) 2012 TO REMOVE DUROM AND THE AVENIR STEM WAS RETAINED. IN THE SECOND REVISION SURGERY ON (B)(6) 2012 ALL THE IMPLANTS INCLUDING AVENIR STEM AND A COCR HUMERAL HEAD WERE REMOVED DUE TO INFECTION. REVIEW OF RECEIVED DATA: A LARGE AMOUNT OF LEGAL DOCUMENTS AS WELL AS OPERATIVE NOTES, SURGEON'S COMMUNICATION AND LABORATORY RESULTS HAVE BEEN RECEIVED AND REVIEWED. THESE DOCUMENTS RANGE FROM THE YEAR 2003 TO 2017. THE RELEVANT DATA IS SUMMARIZED BELOW: SURGICAL NOTES & PATIENT HISTORY: THE PATIENT HISTORY HAS BEEN REVIEWED. THE PATIENT HAS BEEN IMPLANTED A TOTAL HIP PROSTHESIS ON THE RIGHT HIP SIDE ON (B)(6) 2005. THE DUROM-METASUL LDH ACETABULAR COMPONENT HAS BEEN REVISED ON (B)(6) 2012 DUE TO AN ABNORMAL REACTION TO THE METAL-ON-METAL IMPLANT (SEE (B)(4)). ADDITIONALLY, THIS PATIENT HAS ALSO BEEN IMPLANTED A TOTAL HIP PROSTHESIS ON THE LEFT HIP SIDE IN 2006, WHICH HAS BEEN REVISED IN 2009 (SEE (B)(4) FOR FIRST REVISION SURGERY) AND AGAIN IN 2015 DUE TO ACETABULAR LOOSENING (SEE (B)(4) FOR SECOND REVISION SURGERY). THE SURGICAL REPORT OF THE FIRST REVISION SURGERY ON (B)(6) 2012 HAS BEEN REVIEWED. IT WAS REPORTED THAT THERE HAS BEEN AN ABNORMAL REACTION TO THE METAL-ON-METAL IMPLANT, SUSPECTED TO BE OF THE TYPE ALVAL. DURING THE SURGERY, THE TUMOR OF THE SIZE OF AN ORANGE IS REMOVED. ACETABULAR AS WELL AS FEMORAL OSTEOLYSES IS DETECTED. THE FEMORAL HEAD AND THE ACETABULAR CUP ARE EXPLANTED WITHOUT DIFFICULTIES. A CUP NOVAE E SERF 55, A POLYETHYLENE INLAY 55-28 SERF AND A ZIMMER METAL HEAD OF SIZE 28 WITH MEDIUM NECK ARE IMPLANTED. AS THE STEM IS NOTED TO BE WELL FIXED, IT IS RETAINED. PERFECT STABILITY HAS BEEN ACHIEVED. THE SURGICAL REPORT OF THE SECOND REVISION SURGERY ON (B)(6) 2012 HAS BEEN REVIEWED. PRE-OPERATIVE DIAGNOSIS: INFECTIOUS COMPLICATIONS AND INFLAMMATORY REACTION DUE TO THE OTHER PROSTHESES, IMPLANTS AND BONE GRAFTS. (REMARK: IT NEEDS TO BE MENTIONED, THAT IT IS NOT FURTHER SPECIFIED HOW "OTHER" CAN BE INTERPRETED.) INTERVENTION: REMOVAL OF THE TOTAL HIP PROSTHESIS. OPERATION: DURING SURGERY IT IS STATED THAT THE STEM WAS WELL FIXED. IT HAS REMOVED WITH AN EXTRACTION KIT. AN ENLARGED SYNOVECTOMY IS CONDUCTED, CONSIDERING THE HISTORY OF PSEUDO TUMOR AND INFECTION. SUBSEQUENTLY THE CUP IS ALSO REMOVED. NO COMPLICATIONS ARE NOTED. COMPLAINT RELATED DOCUMENTS: THE BIOLOGICAL SAMPLES AFTER THE FIRST REVISION SURGERY ON (B)(6) 2012 DETECTED FIBRINOIDE NECROSIS, FORMING A PSEUDO-TUMOR, WHICH IS SURROUNDED BY A THICK FIBRO-HYALINE CAPSULE. THIS LEAD TO AN INFLAMMATORY REACTION DUE TO RESORPTION. NO INFECTION HAS BEEN DETECTED. DR (B)(6) DETECTED THE FOLLOWING: (B)(6) 2012: A SMALL INFLAMMATION IN THE PERIPHERY OF THE CLIPS WAS DETECTED DURING CLINICAL EXAMINATION (B)(6) 2012: NO INFLAMMATION AT SCAR DETECTED. THERE IS A SMALL HEMATOMA UNDERNEATH THE SCAR WITHOUT DISCHARGE. (B)(6) 2012: HEMATOMA WAS FOUND TO BE DECREASING. THE CRP WAS DESCRIBED AS A BIT HIGH WITH A VALUE OF 27.6 (MG/L). (B)(6) 2012: NO INFLAMMATION AT SCAR DETECTED. HOWEVER, IT IS MENTIONED THAT THE SCAR NEEDS TO BE MONITORED. THE CRP HAS BEEN 95.2 MG/L. DR (B)(6) STATED ON (B)(6), 2012 THAT ON (B)(6) THE CRP VALUE HAS BEEN 8 MG/L AND THEREFORE THERE IS AN INFLAMMATORY SYNDROME. ON (B)(6) HE CONFIRMED THAT THERE IS NO INFLAMMATION AT THE SCAR, BUT AN OEDEMATOUS APPEARANCE AT THE UPPER REGION. THE PATIENT HAS MADE POULTICES OF CLAY. ON (B)(6) THE PATIENT DID HAVE A DISCHARGE AT THE SCAR WITHOUT TEMPERATURE OR PAIN (CPR 8). ON (B)(6) THE PATIENT NOTED A SIGNIFICANT DISCHARGE AT THE SCAR OVERNIGHT. SUBSEQUENTLY ON (B)(6), (B)(6) HAVE BEEN DETECTED AND THE PATIENT STARTED TAKING ANTIBIOTICS. ADDITIONALLY, ON (B)(6) 2012 ANOTHER INTERVENTION TOOK PLACE. THE SURGICAL NOTES HAVE BEEN REVIEWED. PRE-OPERATIVE DIAGNOSTIC: FISTULA AT SCAR. INTERVENTION: EXCISION OF THE FISTULA AND WASHING OF THE TOTAL HIP IMPLANT. ON (B)(6) 2012 DR (B)(6) DESCRIBED, THAT GRANULATION TISSUE HAS BEEN DETECTED ON THE SCAR ON (B)(6), WHICH HAS DECREASED UNTIL (B)(6) 2012. THIS WOULD PROVE THAT THE INFECTION IS NOT DECREASING. ON (B)(6) 2012 DR (B)(6) STATED THAT THE INFLAMMATORY SYNDROME HAS BEEN REACTIVATED END OF AUGUST. IN THE SAMPLES TAKING DURING SURGERY ON (B)(6) 2012 PROPIONIBACTERIUM ACNES HAS BEEN DETECTED. DESPITE THE ANTIBIOTICS THERAPY, THE DISCHARGE STILL EXISTED IN (B)(6). THEREFORE THE DECISION FOR A REVISION SURGERY WAS TAKEN. DR (B)(6) STATED ON (B)(6) 2012 THAT HE HAS TWO HYPOTHESES CONCERNING THE PHYSIOPATHOLOGY OF THE INFECTION. IT IS A CHRONIC SEPSIS OF PROPIONIBACTERIUM ACNES WITH AN INFLAMMATORY PSEUDO-TUMOR, DEVELOPING SINCE 2005 OR ITS ORIGIN COULD BE A DENTAL INFECTION TRANSMITTED BY BLOOD. SURPRISING WOULD BE THAT THE SAMPLES TAKEN IN JULY DID STAY STERILE (BUT THIS WOULD ALWAYS BE POSSIBLE WITH PROPIONIBACTERIUM ACNES AND ONLY ONE SAMPLE HAS BEEN TAKEN). THE OTHER HYPOTHESIS WOULD BE, THAT IT IS AN ASEPTIC PSEUDO-TUMOR AROUND A METAL-ON-METAL ARTICULATION WITH AN INFECTION ACQUIRED DURING THE SURGERY IN (B)(6). ON (B)(6) 2013 DR (B)(6) STATED AGAIN THAT THE PATIENT SUFFERED A SEPSIS OF PROPIONIBACTERIUM ACNES INITIALLY ASSOCIATED WITH AN INFLAMMATORY PSEUDO TUMOR. THE LABORATORY TEST RESULTS FROM (B)(6), 2012 STATED THAT NO GERM HAS BEEN DETECTED IN THE SAMPLE TAKEN FROM THE FISTULA ON (B)(6), 2012. THE SAMPLE IS CONSIDERED STERILE. ON (B)(6) 2016 DR (B)(6) HAS WRITTEN AN EXPERT REPORT ABOUT THE PATIENT HISTORY. HE STATES THAT THE INFECTION WAS DETECTED ON (B)(6) 2012. IT WOULD HAVE BEEN SUSPECTED, THAT THERE IS A PRECEDING CHRONIC INFECTION, RESULTING FROM THE SYNOVIAL SWELLING FOUND DURING THE FIRST REVISION SURGERY. HE CONCLUDED THAT ALL COMPLICATIONS APPEARING AFTER (B)(6) 2009 ARE ATTRIBUTABLE TO THE METAL-ON-METAL TOTAL HIP PROSTHESES IMPLANTED IN 2005 AND 2006. DEVICES ANALYSIS: NO PRODUCT WAS RETURNED TO ZIMMER BIOMET FOR IN-DEPTH ANALYSIS. ACCORDING TO THE INFORMATION RECEIVED, THE PRODUCT LOCATION IS UNKNOWN. REVIEW OF PRODUCT DOCUMENTATION: IMPLANTS NOT COMPATIBLE: A ZIMMER COCR HEAD WAS REPORTED TO BE USED IN COMBINATION WITH A DUAL MOBILITY CUP AND LINER OF THE NOVAE PRODUCT LINE MANUFACTURED BY THE COMPANY SERF. COMBINATION OF THE REPORTED HEAD WITH THIS CUP AND LINER IS NOT ALLOWED BY ZIMMER BIOMET. ONLY THE ADES SYSTEM OF DEDIENNE/SERF HAS BEEN DETERMINED TO BE COMPATIBLE WITH CERTAIN HUMERAL HEADS FROM ZIMMER BIOMET. THE INTERNAL DOCUMENTS OF THE AVENIR STEM WERE REVIEWED. THE DHR (DEVICE HISTORY RECORDS) OF THE AVENIR STEM INDICATE THAT THE RELEASED COMPONENT MET ALL REQUIREMENTS TO PERFORM AS INTENDED. THEREFORE IT CAN BE CONCLUDED THAT THE DEVICE WAS ACCORDING TO PRODUCT SPECIFICATION. THE STERILIZATION STEP FOR LOT 4005393 HAS BEEN LISTED IN THE DHR. AT THIS TIME, THE STERILIZATION OF AVENIR STEMS HAVE BEEN PERFORMED BY SYNERGY HEALTH. THEREFORE ALL STERILIZATION CERTIFICATED WHICH COVER THE INDICATED TIMEFRAME HAVE BEEN REVIEWED. THE STERILIZATION CERTIFICATES WERE FOUND TO BE ACCORDING TO THE SPECIFICATIONS. ADDITIONALLY, THE PRODUCT HISTORY HAS BEEN REVIEWED. THERE HAS BEEN NO ADDITIONAL REPORTED INFECTION FOR THE AVENIR STEM REFERENCE NUMBER AND THE LOT NUMBER AFFECTED IN THE COMPLAINT. AS THE REFERENCE NUMBER AND THE LOT NUMBER OF THE COCR HEAD REMAINS UNKNOWN, NO INTERNAL DOCUMENTS COULD BE REVIEWED. THE IFU FOR ENDOPROSTHESIS D011500200 STATES THAT ¿EARLY OR LATE INFECTIONS¿ ARE ¿POSSIBLE CONSEQUENCES OF AN IMPLANT¿ AND SHOULD BE CONSIDERED WHEN IMPLANTING ZIMMER BIOMET DEVICES. ADDITIONALLY, IT IS STATED THAT "BEFORE STERILE IMPLANTS ARE REMOVED FROM THEIR PACKAGING, THE PROTECTIVE WRAPPING MUST BE EXAMINED FOR POSSIBLE DAMAGE AS THIS COULD JEOPARDIZE THEIR STERILITY." AND "IF THE PACKAGING IS DAMAGED OR THE STERILITY EXPIRATION DATE HAS BEEN REACHED, THE IMPLANTS MUST BE RETURNED TO THE MANUFACTURER.". ROOT CAUSE ANALYSIS: ROOT CAUSE DETERMINATION USING DFMEA: INFECTION DUE TO FAILURE OF STERILIZATION PROCEDURE DUE TO SUPPLIER PROCESS -> NOT POSSIBLE: THE STERILIZATION CERTIFICATES HAVE BEEN REVIEWED AND THEY CONFIRM THAT THE PRODUCT HAS BEEN STERILIZED ACCORDING TO THE SPECIFICATIONS. TRANSMISSION OF INFECTIOUS AGENTS, INFECTION DUE TO REUSE OF THE DEVICE WHICH IS ONLY INTENDED FOR SINGLE USE => POSSIBLE: IT IS UNKNOWN, WHETHER THE DEVICE WAS REUSED OR NOT. AS THE REF OF THE COCR HEAD REMAINS UNKNOWN, ALL POSSIBLE CAUSES WILL BE LISTED FOR A SIMILAR/COMPARABLE DEVICE FROM ZIMMER'S PORTFOLIO (SIMILAR DESIGN, FUNCTION, INTENDED USE). REFERRED SYSTEM/PRODUCT GROUP: COCR HEADS, USING DFMEA: INFECTION DUE TO FAILURE OF STERILISATION PROCEDURE => POSSIBLE: THE DHR AND STERILIZATION CERTIFICATE OF THE PRODUCT COULD NOT BE CHECKED AS NO LOT IS AVAILABLE, THEREFORE CANNOT BE EXCLUDED. HOWEVER, THE GAMMA STERILIZATION SPECIFICATION CERTIFIES THE SUITABILITY OF STERILIZATION. CROSS CONTAMINATION DUE TO COCR HEADS ARE RE-USED AGAINST MANUFACTURERS DIRECTIONS PROVIDED ON BOX LABELING AND IFU. POSSIBLE: IT IS UNKNOWN, WHETHER THE DEVICE WAS REUSED OR NOT. TRANSMISSION OF INFECTIOUS AGENTS OR MECHANICAL FAILURE DUE TO REUSE OF THE DEVICE WHICH IS ONLY INTENDED FOR SINGLE USE. POSSIBLE: IT IS UNKNOWN, WHETHER THE DEVICE WAS REUSED OR NOT. CONCLUSION SUMMARY: IT WAS REPORTED, THAT A PATIENT HAD A RIGHT HIP PROSTHESIS IMPLANTED ON THE LEFT HIP SIDE ON (B)(6) 2005. THE ACETABULAR COMPONENTS AND THE HEAD HAVE BEEN REVISED ON (B)(6) 2012, THE AVENIR STEM WAS RETAINED. THE PATIENT GOT A ZIMMER COCR HEAD IMPLANTED. THE SECOND REVISION SURGERY TOOK PLACE ON (B)(6) 2012 DUE TO INFECTION. ALL COMPONENTS HAVE BEEN REMOVED. THE DHR (DEVICE HISTORY RECORDS) OF THE AVENIR STEM INDICATE THAT THE RELEASED COMPONENT MET ALL REQUIREMENTS TO PERFORM AS INTENDED. THEREFORE, IT CAN BE CONCLUDED THAT THE DEVICE WAS ACCORDING TO PRODUCT SPECIFICATION. THE STERILIZATION STEP FOR LOT 4005393 HAS BEEN LISTED IN THE DHR AND THE STERILIZATION CERTIFICATES CONFIRM THAT THE PRODUCT WAS STERILIZED ACCORDING TO THE SPECIFICATIONS. MOREOVER, THERE HAS BEEN NO ADDITIONAL PREVIOUSLY REPORTED EVENT FOR THE PRODUCT REFERENCE NUMBER AS WELL AS FOR THE PRODUCT LOT NUMBER AFFECTED IN THE COMPLAINT. ADDITIONALLY THE REVISION SURGERY TOOK PLACE 7 YEARS AFTER IMPLANTATION. THE PRODUCT REFERENCE NUMBER AS WELL AS FOR THE PRODUCT LOT NUMBER OF THE FEMORAL COCR HEAD REMAINS UNKNOWN, THEREFORE THE STERILIZATION CERTIFICATES COULD NOT BE REVIEWED. SINGLE USE STERILIZED DEVICES MANUFACTURED OR DISTRIBUTED BY ZIMMER BIOMET ARE STERILIZED IN ACCORDANCE WITH FDA REGULATIONS AND ISO STANDARDS TO A STERILITY ASSURANCE LEVEL OF 1.0 X 10-6 OR BETTER. THEREFORE, IT IS VERY UNLIKELY THAT EITHER THE AVENIR STEM OR THE COCR HUMERAL HEAD CAUSED OR CONTRIBUTED TO ANY PATIENT INFECTION. IMPROPER TRANSPORT, STORAGE AND HANDLING OF THE COMPONENT COULD HAVE COMPROMISED THE STERILIZATION OF THE PRODUCTS. HOWEVER, TRANSPORT, STORAGE AND HANDLING OF THE COMPONENTS IS OUTSIDE OF ZIMMER BIOMET CONTROL. THE IFU FOR ENDOPROSTHESIS STATES THAT ¿EARLY OR LATE INFECTIONS¿ ARE ¿POSSIBLE CONSEQUENCES OF AN IMPLANT¿ AND THAT THE PRODUCT PACKAGING MUST BE EXAMINED FOR POSSIBLE DAMAGE. AS MENTIONED IN THE RECEIVED DOCUMENTS, ONE POSSIBLE ROOT CAUSE FOR THE INFECTION COULD HAVE BEEN THE INFLAMMATORY PSEUDO-TUMOR, WHICH HAS BEEN REMOVED DURING THE FIRST REVISION SURGERY ON (B)(6) 2012. AS THE PRODUCT HAS NOT BEEN RETURNED FOR AN INVESTIGATION, AN EXACT ROOT CAUSE CANNOT BE DETERMINED. HOWEVER, BASED ON THE GIVEN INFORMATION AND PERFORMED INVESTIGATION, THERE IS NO EVIDENCE FOR AN IMPLANT FAILURE WHICH COULD HAVE INFLUENCED THE REPORTED EVENT. AN OFFLABEL PRODUCT COMBINATION OF THE COCR HEAD WITH COMPETITOR ACETABULAR PRODUCTS DID TAKE PLACE. IT CANNOT BE EXCLUDED WHETHER THE COMPETITOR'S PRODUCTS DID CAUSE OR CONTRIBUTE TO THE INFECTION. NOTE:FOR THE AVENIR STEM AN ADDITIONAL MEDWATCH WILL BE SENT. HOWEVER, THE INVESTIGATION RESULTS OF THIS DEVICE INCLUDE ALSO THE AVENIR STEM. THE NEED FOR CORRECTIVE MEASURES IS NOT INDICATED AND ZIMMER GMBH CONSIDERS THIS CASE AS CLOSED. ZIMMER BIOMET¿S REFERENCE NUMBER OF THIS FILE IS (B)(4).
SURGICAL REPORTS (OPERATIVE REPORTS) WERE RECEIVED AND WILL BE REVIEWED AS PART OF ONGOING INVESTIGATION. THE MANUFACTURER DID NOT RECEIVE THE DEVICE FOR INVESTIGATION. AS NO LOT NUMBER WAS PROVIDED, THE DEVICE HISTORY RECORDS COULD NOT BE REVIEWED. A CAUSE FOR THIS SPECIFIC EVENT CANNOT BE ASCERTAINED FROM THE INFORMATION PROVIDED. AS SOON AS SUPPLEMENTAL INFORMATION BECOMES AVAILABLE AN UPDATED REPORT WILL BE SUBMITTED. ADDITIONAL INFORMATION HAS BEEN REQUESTED AND IS CURRENTLY NOT AVAILABLE. (B)(4).
IT WAS REPORTED THAT THE PATIENT WAS IMPLANTED AN COCR HUMERAL HEAD (CATALOGUE NUMBER UNKNOWN) ON THE RIGHT SIDE ON (B)(6) 2012 AND THE PATIENT UNDERWENT REVISION SURGERY ON (B)(6) 2012 DUE TO INFECTION.
IT WAS REPORTED THAT THE PATIENT WAS IMPLANTED AN UNKNOWN SULOX HEAD HIP IMPLANT(CATALOGUE NUMBER UNKNOWN) ON THE RIGHT SIDE ON (B)(6) 2012 AND THE PATIENT UNDERWENT REVISION SURGERY ON (B)(6) 2012 DUE TO INFECTION.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 464505 | COCR HEAD | UNKNOWN | JDI | ZIMMER GMBH | N/A | UNKNOWN |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 75 YR | Hospitalization| R |