BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SFX SPI PDS+ UNI 18IN 3-0 SA PS-2 PRM

    MDR report key: 12787478 · Received November 10, 2021

    Report

    Report Number
    2210968-2021-11187
    Event Type
    Injury
    Date Received
    November 10, 2021
    Report Date
    February 9, 2022
    Manufacturer
    ETHICON INC.
    Product Code
    NEW
    UDI-DI
    10705031236257
    PMA / PMN Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). THIS IS A COMBINATION PRODUCT, AND THE EVENT HAS BEEN REVIEWED FOR BOTH THE SUTURE AND THE TRICLOSAN. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL REPORT, A FOLLOW-UP REPORT WILL BE FILED AS APPROPRIATE. (B)(4). TO DATE THE DEVICE HAS NOT BEEN RETURNED. IF THE DEVICE OR FURTHER DETAILS ARE RECEIVED AT A LATER DATE A SUPPLEMENTAL MEDWATCH WILL BE SENT. ADDITIONAL INFORMATION WAS REQUESTED AND THE FOLLOWING WAS OBTAINED: COULD YOU PLEASE EXPLAIN WHAT WAS THE EXACT ISSUE RELATED TO THE DEVICE? PLEASE CLARIFY: CRP VALUE WAS ELEVATED POSTOPERATIVELY. WHAT DO YOU MEAN BY CRP ELEVATED, WAS THERE A CONFIRMED INFLAMMATION OR INFECTION? THE CAUSE IS UNKNOWN, BUT THE SURGEON GUESSED THIS; THE SURGEON SAID HE USED MORE SUTURES IN THE SURGERY THAN USUAL, SO IT MEANS THERE WERE MORE FOREIGN MATTER IN THE PATIENT¿S BODY. WAS THERE ANY MEDICAL OR SURGICAL INTERVENTION PERFORMED TO TREAT THIS ISSUE(RE-OPERATION; RE-SUTURING; PRESCRIPTION STEROIDS; ANTIBIOTICS PRESCRIBED)? RE-OPERATION. WAS ANY QUALITY DEFICIENCY/NON-CONFORMANCE NOTED WITH THE SUTURE BEFORE USE, DURING USE, DURING POST-OP EXAMINATION OR DURING RE-OPERATION IF PERFORMED? NO. DOES THE SURGEON BELIEVE THAT ETHICON PRODUCT SXPP1A401 INVOLVED CAUSED AND/OR CONTRIBUTED TO THE ADVERSE EVENT DESCRIBED? THE SURGEON SAID HE USED MORE SUTURES IN THE SURGERY THAN USUAL, SO IT MEANS THERE WERE MORE FOREIGN MATTER IN THE PATIENTS BODY. THE FOLLOWING INFORMATION WAS REQUESTED, BUT UNAVAILABLE: DID THE ISSUE CRP VALUE ELEVATED WAS RELATED TO THE ETHICON PRODUCT? WHAT IS THE CURRENT CONDITION OF THE PATIENT? WHAT IS THE LOT NUMBER? ATTEMPTS ARE BEING MADE TO OBTAIN THE FOLLOWING INFORMATION. TO DATE NO RESPONSE HAS BEEN PROVIDED. IF FURTHER DETAILS ARE RECEIVED AT A LATER DATE A SUPPLEMENTAL MEDWATCH WILL BE SENT. PLEASE PROVIDE THE PATIENT'S DEMOGRAPHIC INFORMATION INCLUDING AGE, GENDER, WEIGHT, BMI AT THE TIME OF INDEX PROCEDURE. WERE THERE ANY PRE-EXISTING SIGNS/SYMPTOMS OF ACTIVE INFLAMMATION PRIOR TO THIS SURGICAL PROCEDURE? DID THE PATIENT RECEIVE ANY PROPHYLACTIC ANTIBIOTICS PRE-, INTRA- OR POST-OPERATION? WERE ANY PRE-OP CLEANSING PROCEDURES OR PRODUCTS CHANGED RECENTLY? IF YES, PLEASE DESCRIBE. FOR STRATAFIX SPIRAL PDS PLUS, PRODUCT CODE SXPP1B105: WHAT TISSUE WAS STRATAFIX SPIRAL PDS PLUS, PRODUCT CODE SXPP1B105 USED ON? HOW WAS SUTURE INITIALLY PLACED (INTERRUPTED OR CONTINUOUS)? WHAT WAS THE TISSUE CONDITION WHERE STRATAFIX SPIRAL PDS PLUS, PRODUCT CODE SXPP1B105 WAS USED? WAS THE TISSUE CONDITION, I.E., NORMAL OR THIN, CALCIFIED, FRAGILE, DISEASED? DOES THE SURGEON BELIEVE THAT THE ETHICON PRODUCT (STRATAFIX SPIRAL PDS PLUS, PRODUCT CODE SXPP1B105) WAS INVOLVED IN, CAUSED AND/OR CONTRIBUTED TO THE ADVERSE EVENT DESCRIBED? FOR STRATAFIX SYMMETRIC PDS PLUS, PRODUCT CODE SXPP1A401: WHAT TISSUE WAS STRATAFIX SPIRAL PDS PLUS, PRODUCT CODE SXPP1A401 USED ON? HOW WAS SUTURE INITIALLY PLACED (INTERRUPTED OR CONTINUOUS)? WHAT WAS THE TISSUE CONDITION WHERE STRATAFIX SPIRAL PDS PLUS, PRODUCT CODE SXPP1A401 WAS USED? WAS THE TISSUE CONDITION, I.E., NORMAL OR THIN, CALCIFIED, FRAGILE, DISEASED? DOES THE SURGEON BELIEVE THAT THE ETHICON PRODUCT (STRATAFIX SYMMETRIC PDS+, PRODUCT CODE SXPP1A401) WAS INVOLVED IN, CAUSED AND/OR CONTRIBUTED TO THE ADVERSE EVENT DESCRIBED? PATIENT SYMPTOMS MANIFESTATIONS OF INFLAMMATION (LOCATION, SEVERITY, APPEARANCE, SYSTEMIC OR LOCAL REACTION). WHAT WAS THE REASON/INDICATION FOR RE-OPERATION? PLEASE SPECIFY. WHAT WAS THE DATE OF THE RE-OPERATION? WHAT DO YOU MEAN BY ¿HE USED MORE SUTURES IN THE SURGERY THAN USUAL¿ PLEASE CLARIFY/EXPLAIN. DATE OF DIAGNOSIS OF THE ELEVATED CRP? PATIENT SYMPTOMS MANIFESTATIONS OF POST-OP INFLAMMATION (LOCATION, SEVERITY, APPEARANCE, SYSTEMIC OR LOCAL REACTION). OTHER RELEVANT PATIENT HISTORY/CONCOMITANT MEDICATIONS? WHAT IS THE PHYSICIAN¿S OPINION AS TO THE ETIOLOGY OF OR CONTRIBUTING FACTORS TO THIS EVENT? WHAT IS THE PATIENT'S CURRENT STATUS? IS THE LOT NUMBER FOR PRODUCT CODE SXPP1B105 OR FOR PRODUCT CODE SXPP1A401 AVAILABLE? NOTE: EVENT IS REPORTED IN 2210968-2021-11188. TRADE NAME - IRGACARE®; ACTIVE INGREDIENT(S) ¿ TRICLOSAN; DOSAGE FORM ¿ SUTURE/SOLID/PARENTERAL; STRENGTH ¿ 2360 G/M.

    Additional Manufacturer Narrative · 0

    PRODUCT COMPLAINT # (B)(4). THIS REPORT IS BEING SUBMITTED PURSUANT TO THE PROVISIONS OF 21 CFR, PART 803, PART 4 SUBPART B. 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 ETHICON, OR ITS EMPLOYEES THAT THE REPORT CONSTITUTES AN ADMISSION THAT THE PRODUCT, ETHICON, 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 INFORMATION WAS REQUESTED, AND THE FOLLOWING WAS OBTAINED: IT WAS REPORTED THAT STRATAFIX SPIRAL PDS PLUS, STRATAFIX SYMMETRIC PDS PLUS, PDS (FOR DERMIS) AND VICRYL (FOR FASCIA) WERE USED ON THIS PATIENT. THIS COMPLAINT IS AGAINST STRATAFIX SPIRAL PDS PLUS AND STRATAFIX SYMMETRIC PDS PLUS. DOES THE SURGEON BELIEVE THE PDS (FOR DERMIS) AND VICRYL (FOR FASCIA) CAUSED OR CONTRIBUTED TO THE INCREASED CRP ALSO? WHICH SUTURE OF THE FOUR USED CONTRIBUTED TO CPR INCREASE WAS UNKNOWN. JUST HE SAID HE USED MORE SUTURE THAN USUAL TKA, POSSIBLY IT CAUSED THAT.

    Additional Manufacturer Narrative · 0

    PRODUCT COMPLAINT # (B)(4). THIS REPORT IS BEING SUBMITTED PURSUANT TO THE PROVISIONS OF 21 CFR, PART 803, PART 4 SUBPART B. 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 ETHICON, OR ITS EMPLOYEES THAT THE REPORT CONSTITUTES AN ADMISSION THAT THE PRODUCT, ETHICON, 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 INFORMATION WAS REQUESTED AND THE FOLLOWING WAS OBTAINED: PLEASE PROVIDE THE PATIENT'S DEMOGRAPHIC INFORMATION INCLUDING AGE, GENDER, WEIGHT, BMI AT THE TIME OF INDEX PROCEDURE: UNKNOWN. WERE THERE ANY PRE-EXISTING SIGNS/SYMPTOMS OF ACTIVE INFLAMMATION PRIOR TO THIS SURGICAL PROCEDURE? NO. DID THE PATIENT RECEIVE ANY PROPHYLACTIC ANTIBIOTICS PRE-, INTRA- OR POST-OPERATION? UNKNOWN. WERE ANY PRE-OP CLEANSING PROCEDURES OR PRODUCTS CHANGED RECENTLY? IF YES, PLEASE DESCRIBE. UNKNOWN. FOR STRATAFIX SPIRAL PDS PLUS, PRODUCT CODE SXPP1B105: WHAT TISSUE WAS STRATAFIX SPIRAL PDS PLUS, PRODUCT CODE SXPP1B105 USED ON? SXPP1B105 WAS USED FOR DERMIS. HOW WAS SUTURE INITIALLY PLACED (INTERRUPTED OR CONTINUOUS)? CONTINUOUS. WHAT WAS THE TISSUE CONDITION WHERE STRATAFIX SPIRAL PDS PLUS, PRODUCT CODE SXPP1B105 WAS USED? WAS THE TISSUE CONDITION, I.E., NORMAL OR THIN, CALCIFIED, FRAGILE, DISEASED? UNKNOWN. DOES THE SURGEON BELIEVE THAT THE ETHICON PRODUCT (STRATAFIX SPIRAL PDS PLUS, PRODUCT CODE SXPP1B105) WAS INVOLVED IN, CAUSED AND/OR CONTRIBUTED TO THE ADVERSE EVENT DESCRIBED? THE SURGEON USED MORE SUTURES THAN THE PREVIOUS TKA, SO IT IS POSSIBLE THAT THE CAUSE WAS A LOT OF FOREIGN MATTER. PATIENT SYMPTOMS MANIFESTATIONS OF INFLAMMATION (LOCATION, SEVERITY, APPEARANCE, SYSTEMIC OR LOCAL REACTION) UNKNOWN. WHAT WAS THE DATE OF THE ANTIBIOTICS WERE PRESCRIBED? UNKNOWN. WHAT DO YOU MEAN BY ¿HE USED MORE SUTURES IN THE SURGERY THAN USUAL¿ PLEASE CLARIFY/EXPLAIN. PREVIOUSLY, THE DOCTOR USED ONLY PDS ( FOR DERMIN ) AND VICRYL ( FOR FASCIA ) IN TKA, BUT THIS PROCEDURE USED SXPP1A401 AND SXPP1B105 IN ADDITION TO THESE TWO. DATE OF DIAGNOSIS OF THE ELEVATED CRP? UNKNOWN. PATIENT SYMPTOMS MANIFESTATIONS OF POST-OP INFLAMMATION (LOCATION, SEVERITY, APPEARANCE, SYSTEMIC OR LOCAL REACTION). UNKNOWN. OTHER RELEVANT PATIENT HISTORY/CONCOMITANT MEDICATIONS? UNKNOWN. WHAT IS THE PHYSICIAN¿S OPINION AS TO THE ETIOLOGY OF OR CONTRIBUTING FACTORS TO THIS EVENT? PREVIOUSLY, THE DOCTOR USED ONLY PDS ( FOR DERMIN ) AND VICRYL ( FOR FASCIA ) IN TKA, BUT THIS PROCEDURE USED SXPP1A401 AND SXPP1B105 IN ADDITION TO THESE TWO. SO, HE SURGEON USED MORE SUTURES THAN THE PREVIOUS TKA, SO IT IS POSSIBLE THAT THE CAUSE WAS A LOT OF FOREIGN MATTER. WHAT IS THE PATIENT'S CURRENT STATUS? NO PROBLEM. IS THE LOT NUMBER FOR PRODUCT CODE SXPP1B105 OR FOR PRODUCT CODE SXPP1A401 AVAILABLE? UNKNOWN.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT A PATIENT UNDERWENT A TOTAL KNEE ARTHROPLASTY ON (B)(6) 2021 AND A BARBED SUTURE WAS USED. POSTOPERATIVELY, THE CRP VALUE WAS ELEVATED. THE PATIENT UNDERWENT REOPERATION. ADDITIONAL INFORMATION WAS REQUESTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1689796 SFX SPI PDS+ UNI 18IN 3-0 SA PS-2 PRM SUTURE, SURGICAL, ABSORBABLE, POLYDIOXANONE NEW ETHICON INC. SXPP1B105 10705031236257

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Required Intervention