GELFOAM
Report
- Report Number
- 1810189-2023-00048
- Event Type
- Injury
- Date Received
- April 21, 2023
- Report Date
- April 13, 2023
- Manufacturer
- PFIZER, INC. (DEVICE)
- Product Code
- LMF
- PMA / PMN Number
- 18-286
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- EG
- Reporter Occupation
- OTHER
- Health Professional
- N
Narratives
THE COMPLAINT OF TWO PATIENTS DEVELOPED ARTHRITIC CHANGES IN GROUP I (GRADE I) FOR GELFOAM STERILE SPONGE SIZE 12-7 MM X 12 WAS INVESTIGATED BY THE MANUFACTURING SITE. A PERFORMANCE NOT AS INDICATED IN LABEL COMPLAINT WAS RECEIVED FOR AN UNKNOWN LOT OF GELFOAM. REVIEW OF COMPLAINTS FOR GELFOAM SPONGE AND POWDER RECEIVED WITHIN 36 MONTHS (THE EXPIRY INTERVAL OF THE PRODUCT) PRIOR TO RECEIPT OF THE REPORTED COMPLAINT. NO PREVIOUS COMPLAINTS WITH A KNOWN BATCH NUMBER WERE IDENTIFIED. EXISTING PROCESS CONTROLS, SUCH AS USE OF A SPECIFIC VALIDATED FORMULATION RECIPE AND AUTOMATIC RECORDING OF ALL WEIGHTS AND IDENTITIES OF RAW MATERIALS, DOCUMENTATION AND VERIFICATION OF CRITICAL FORMULATION, PROCESSING, AND STERILIZATION STEPS, AND FINAL RELEASE TESTING OF EACH BATCH TO ASSURE THAT IT MEETS ALL INTERNAL TARGETS AND REGISTERED SPECIFICATIONS PRIOR TO RELEASE FOR DISTRIBUTION WERE REVIEWED AS A PART OF THIS INVESTIGATION. NO TRENDS WERE NOTED THAT WOULD REQUIRE ADDITIONAL INVESTIGATION. NO RETURNED COMPLAINT SAMPLE WAS RECEIVED. THE COMPLAINT FOR 'PERFORMANCE NOT AS INDICATED IN LABEL' FOR AN UNKNOWN BATCH OF GELFOAM SPONGE WAS INVESTIGATED. THE INVESTIGATION INCLUDED REVIEWING APRRS FOR THE PRODUCT AND A MEDICAL DEVICE TREND REVIEW. THE FINAL SCOPE WAS DETERMINED TO BE ALL BATCHES OF GELFOAM MANUFACTURED BY PFIZER KALAMAZOO WITHIN THE 36 MONTHS (THE EXPIRY INTERVAL OF THE PRODUCT) PRIOR TO THE RECEIPT DATE OF THE COMPLAINT. A COMPLAINT SAMPLE WAS NOT RETURNED. NO RELATED QUALITY ISSUES WERE IDENTIFIED DURING THE INVESTIGATION. NO ROOT CAUSE OR CAPA WERE IDENTIFIED AS THE COMPLAINT WAS NOT CONFIRMED. NO RELATED QUALITY DEFECTS WERE IDENTIFIED THROUGH INVESTIGATION. THERE IS NO IMPACT ON MEDICAL DEVICE QUALITY, REGULATORY, VALIDATION, OR STABILITY.
EVENT VERBATIM [PREFERRED TERM] . TWO PATIENTS DEVELOPED ARTHRITIC CHANGES IN GROUP I (GRADE I) [ARTHRITIS], , NARRATIVE: THIS IS A LITERATURE REPORT FOR THE FOLLOWING LITERATURE SOURCE: "TREATMENT OF GIANT CELL TUMOR OF BONE USING BONE GRAFTING AND CEMENTATION WITH VERSUS WITHOUT GEL FOAM", ALEXANDRIA JOURNAL OF MEDICINE, 2022; VOL:58 (1), PGS:78-84, DOI:10.1080/20905068.2022.2084868. A 43-YEAR-OLD MALE PATIENT RECEIVED ABSORBABLE GELATIN (GELFOAM), FOR BONE GIANT CELL TUMOUR. THE PATIENT'S RELEVANT MEDICAL HISTORY INCLUDED: "GIANT CELL TUMORS" (UNSPECIFIED IF ONGOING), NOTES: RT GCT DISTAL FEMUR (GROUP I); "BONE GRAFTING" (UNSPECIFIED IF ONGOING); "BONE CEMENTATION" (UNSPECIFIED IF ONGOING). THE PATIENT'S CONCOMITANT MEDICATIONS WERE NOT REPORTED. THE FOLLOWING INFORMATION WAS REPORTED: ARTHRITIS (INTERVENTION REQUIRED), OUTCOME "UNKNOWN", DESCRIBED AS "TWO PATIENTS DEVELOPED ARTHRITIC CHANGES IN GROUP I (GRADE I)". THE PATIENT UNDERWENT THE FOLLOWING LABORATORY TESTS AND PROCEDURES: CHEST X-RAY: UNKNOWN RESULTS; HISTOLOGY: UNKNOWN RESULTS, NOTES: WAS PERFORMED TO CONFIRM THE DIAGNOSIS; CLINICAL EXAMINATION: UNKNOWN RESULTS; SHOWING THE RECONSTRUCTION OF THE MEDIAL FEMORAL, NOTES: CONDYLE AFTER EXTENDED CURETTAGE WITH SUBCHONDRAL ILIAC BONE GRAFT FOLLOWED BY GEL FOAM AND CEMENT; MAGNETIC RESONANCE IMAGING: SHOWING HYPOINTENSE LESION WITH CORTICAL THINNING, NOTES: WITHOUT SOFT TISSUE EXTENSION; UNKNOWN RESULTS; X-RAY: OSTEOLYTIC ESION AFFECTING MEDIAL FEMORAL CONDYLE; SHOWING FULL INCORPORATION OF BONE GRAFT AND NO, NOTES: EVIDENCE OF RECURRENCE; UNKNOWN RESULTS. THE ACTION TAKEN FOR ABSORBABLE GELATIN WAS UNKNOWN. THE REPORTER CONSIDERED "TWO PATIENTS DEVELOPED ARTHRITIC CHANGES IN GROUP I (GRADE I)" ASSOCIATED TO ABSORBABLE GELATIN. BACKGROUND: GIANT CELL TUMOR (GCT) OF BONE IS A BENIGN LOCALLY AGGRESSIVE TUMOR THAT CONSTITUTES 20% OF THE BODY'S BENIGN BONE TUMORS. MOST OF THE GCTS EXHIBIT A TYPICAL EPIPHY SEAL LOCATION THAT SHOWS A TENDENCY FOR SIGNIFICANT BONE DESTRUCTION AND LOCAL RECURRENCE. WE AIMED TO ASSESS THE FUNCTIONAL AND ONCOLOGICAL OUTCOMES OF GCT PATIENTS TREATED WITH BONE GRAFTING AND CEMENTATION WITH OR WITHOUT GEL FOAM. MATERIALS AND METHODS: THIS PROSPECTIVE STUDY INCLUDED 40 PATIENTS PRESENTED AT EL HADARA UNIVERSITY HOSPITAL WITH GCT OF BONE AROUND THE KNEE FROM JANUARY 2017 TO JANUARY 2022 TREATED BY BONE GRAFT AND CEMENTATION. TWENTY CASES WERE TREATED WITH GEL FOAM (GROUP I) AND 20 CASES WERE TREATED WITHOUT GEL FOAM (GROUP II) THROUGH RANDOM ALLOCATION WITHOUT SELECTION. RECURRENCE WAS ASSESSED AS PROGRESSIVE LYSIS OF 5 MM AT THE BONE CEMENT INTERFACE. FUNCTIONAL OUTCOMES WERE ASSESSED USING THE MUSCULOSKELETAL TUMOR SOCIETY SCORE (MSTS) AFTER A PERIOD OF MINIMUM 30 MONTHS. RESULTS: IN GROUP I, 18 PATIENTS (90%) HAD EXCELLENT RESULTS (RANGE 24 AND 30) ACCORDING TO MSTS AND TWO PATIENTS (10%) HAD GOOD RESULTS (RANGE 18 AND 23), WHILE IN GROUP II, 16 PATIENTS (80%) HAD EXCELLENT RESULTS AND FOUR PATIENTS (20%) HAD GOOD RESULTS. NO PATIENTS WERE GRADED AS HAVING FAIR OR POOR RESULTS. TWENTY PATIENTS (100%) HAD SATISFACTORY RESULTS, AND NO PATIENTS (0%) HAD UNSATISFACTORY RESULTS. THE OVERALL RECURRENCE RATE WAS ABOUT 15%. CONCLUSION: RECONSTRUCTION OF GCT OF BONE WITH SANDWICH TECHNIQUE OFFERS GOOD OPTION AS JOINT PRESERVING SURGERY. MOST OF THE PATIENTS GET BENEFIT IN TERMS OF BETTER QUALITY OF LIFE AND GOOD FUNCTION REGARDLESS OF AGE AND GENDER. SUBCHONDRAL BONE GRAFTING REDUCES THE EFFECT OF HEAT ON ARTICULAR CARTILAGE, BUT LONGER FOLLOW-UP IS REQUIRED. THERE IS NO BENEFIT OF GEL FOAM ADDITION IN TERMS OF FUNCTION OR ONCOLOGICAL OUTCOME. PRODUCT QUALITY GROUP PROVIDED INVESTIGATIONAL RESULTS ON 21JUN2023 FOR ABSORBABLE GELATIN: THE COMPLAINT OF TWO PATIENTS DEVELOPED ARTHRITIC CHANGES IN GROUP I (GRADE I) FOR GELFOAM STERILE SPONGE SIZE 12-7 MM X 12 WAS INVESTIGATED BY THE MANUFACTURING SITE. A PERFORMANCE NOT AS INDICATED IN LABEL COMPLAINT WAS RECEIVED FOR AN UNKNOWN LOT OF GELFOAM. REVIEW OF COMPLAINTS FOR GELFOAM SPONGE AND POWDER RECEIVED WITHIN 36 MONTHS (THE EXPIRY INTERVAL OF THE PRODUCT) PRIOR TO RECEIPT OF THE REPORTED COMPLAINT. NO PREVIOUS COMPLAINTS WITH A KNOWN BATCH NUMBER WERE IDENTIFIED. EXISTING PROCESS CONTROLS, SUCH AS USE OF A SPECIFIC VALIDATED FORMULATION RECIPE AND AUTOMATIC RECORDING OF ALL WEIGHTS AND IDENTITIES OF RAW MATERIALS, DOCUMENTATION AND VERIFICATION OF CRITICAL FORMULATION, PROCESSING, AND STERILIZATION STEPS, AND FINAL RELEASE TESTING OF EACH BATCH TO ASSURE THAT IT MEETS ALL INTERNAL TARGETS AND REGISTERED SPECIFICATIONS PRIOR TO RELEASE FOR DISTRIBUTION WERE REVIEWED AS A PART OF THIS INVESTIGATION. NO TRENDS WERE NOTED THAT WOULD REQUIRE ADDITIONAL INVESTIGATION. NO RETURNED COMPLAINT SAMPLE WAS RECEIVED. THE COMPLAINT FOR 'PERFORMANCE NOT AS INDICATED IN LABEL' FOR AN UNKNOWN BATCH OF GELFOAM SPONGE WAS INVESTIGATED. THE INVESTIGATION INCLUDED REVIEWING APRRS FOR THE PRODUCT AND A MEDICAL DEVICE TREND REVIEW. THE FINAL SCOPE WAS DETERMINED TO BE ALL BATCHES OF GELFOAM MANUFACTURED BY PFIZER KALAMAZOO WITHIN THE 36 MONTHS (THE EXPIRY INTERVAL OF THE PRODUCT) PRIOR TO THE RECEIPT DATE OF THE COMPLAINT. A COMPLAINT SAMPLE WAS NOT RETURNED. NO RELATED QUALITY ISSUES WERE IDENTIFIED DURING THE INVESTIGATION. NO ROOT CAUSE OR CAPA WERE IDENTIFIED AS THE COMPLAINT WAS NOT CONFIRMED. NO RELATED QUALITY DEFECTS WERE IDENTIFIED THROUGH INVESTIGATION. THERE IS NO IMPACT ON MEDICAL DEVICE QUALITY, REGULATORY, VALIDATION, OR STABILITY. NO FOLLOW-UP ATTEMPTS ARE POSSIBLE. NO FURTHER INFORMATION IS EXPECTED. FOLLOW-UP (16JUN2023): FOLLOW-UP ATTEMPTS ARE COMPLETED. NO FURTHER INFORMATION IS EXPECTED. FOLLOW-UP (21JUN2023): THIS IS A FOLLOW-UP REPORT FROM PFIZER PRODUCT QUALITY GROUP PROVIDING INVESTIGATION RESULTS. FOLLOW-UP ATTEMPTS ARE COMPLETED. NO FURTHER INFORMATION IS EXPECTED., COMMENT: THE EVENT ARTHRITIS IS ASSESSED AS SERIOUS, ASSOCIATED WITH THE PRODUCT ABSORBABLE GELATIN (GELFOAM), AND UNLISTED IN THE CDS OF THE PFIZER SUSPECT PRODUCT ABSORBABLE GELATIN. THIS CASE WILL BE REASSESSED WHEN ADDITIONAL INFORMATION IS RECEIVED. THE IMPACT OF THIS REPORT ON THE BENEFIT/RISK PROFILE OF THE PFIZER PRODUCT IS EVALUATED AS PART OF PFIZER PROCEDURES FOR SAFETY EVALUATION, INCLUDING THE REVIEW AND ANALYSIS OF AGGREGATE DATA FOR ADVERSE EVENTS. ANY SAFETY CONCERN IDENTIFIED AS PART OF THIS REVIEW, AS WELL AS ANY APPROPRIATE ACTION IN RESPONSE, WILL BE PROMPTLY NOTIFIED TO REGULATORY AUTHORITIES, ETHICS COMMITTEES AND INVESTIGATORS, AS APPROPRIATE.
EVENT VERBATIM [PREFERRED TERM] TWO PATIENTS DEVELOPED ARTHRITIC CHANGES IN GROUP I (GRADE I) [ARTHRITIS], , NARRATIVE: THIS IS A LITERATURE REPORT FOR THE FOLLOWING LITERATURE SOURCE(S): "TREATMENT OF GIANT CELL TUMOR OF BONE USING BONE GRAFTING AND CEMENTATION WITH VERSUS WITHOUT GEL FOAM", ALEXANDRIA JOURNAL OF MEDICINE, 2022; VOL:58 (1), PGS:78-84, DOI:10.1080/20905068.2022.2084868. A 43-YEAR-OLD MALE PATIENT RECEIVED ABSORBABLE GELATIN (GELFOAM), FOR BONE GIANT CELL TUMOUR. THE PATIENT'S RELEVANT MEDICAL HISTORY INCLUDED: "GIANT CELL TUMORS" (UNSPECIFIED IF ONGOING), NOTES: RT GCT DISTAL FEMUR (GROUP I); "BONE GRAFTING" (UNSPECIFIED IF ONGOING); "BONE CEMENTATION" (UNSPECIFIED IF ONGOING). THE PATIENT'S CONCOMITANT MEDICATIONS WERE NOT REPORTED. THE FOLLOWING INFORMATION WAS REPORTED: ARTHRITIS (INTERVENTION REQUIRED), OUTCOME "UNKNOWN", DESCRIBED AS "TWO PATIENTS DEVELOPED ARTHRITIC CHANGES IN GROUP I (GRADE I)". THE PATIENT UNDERWENT THE FOLLOWING LABORATORY TESTS AND PROCEDURES: CHEST X-RAY: UNKNOWN RESULT; HISTOLOGY: UNKNOWN RESULT, NOTES: WAS PERFORMED TO CONFIRM THE DIAGNOSIS; CLINICAL EXAMINATION: UNKNOWN RESULT; SHOWING THE RECONSTRUCTION OF THE MEDIAL FEMORAL, NOTES: CONDYLE AFTER EXTENDED CURETTAGE WITH SUBCHONDRAL ILIAC BONE GRAFT FOLLOWED BY GEL FOAM AND CEMENT; MAGNETIC RESONANCE IMAGING: SHOWING HYPOINTENSE LESION WITH CORTICAL THINNING, NOTES: WITHOUT SOFT TISSUE EXTENSION; UNKNOWN RESULT; X-RAY: OSTEOLYTIC ESION AFFECTING MEDIAL FEMORAL CONDYLE; SHOWING FULL INCORPORATION OF BONE GRAFT AND NO, NOTES: EVIDENCE OF RECURRENCE; UNKNOWN RESULT. THE ACTION TAKEN FOR ABSORBABLE GELATIN WAS UNKNOWN. THE REPORTER CONSIDERED "TWO PATIENTS DEVELOPED ARTHRITIC CHANGES IN GROUP I (GRADE I)" ASSOCIATED TO ABSORBABLE GELATIN. BACKGROUND: GIANT CELL TUMOR (GCT) OF BONE IS A BENIGN LOCALLY AGGRESSIVE TUMOR THAT CONSTITUTES 20% OF THE BODY'S BENIGN BONE TUMORS. MOST OF THE GCTS EXHIBIT A TYPICAL EPIPHY SEAL LOCATION THAT SHOWS A TENDENCY FOR SIGNIFICANT BONE DESTRUCTION AND LOCAL RECURRENCE. WE AIMED TO ASSESS THE FUNCTIONAL AND ONCOLOGICAL OUTCOMES OF GCT PATIENTS TREATED WITH BONE GRAFTING AND CEMENTATION WITH OR WITHOUT GEL FOAM. MATERIALS AND METHODS: THIS PROSPECTIVE STUDY INCLUDED 40 PATIENTS PRESENTED AT(B)(6) HOSPITAL WITH GCT OF BONE AROUND THE KNEE FROM (B)(6) 2017 TO (B)(6) 2022 TREATED BY BONE GRAFT AND CEMENTATION. TWENTY CASES WERE TREATED WITH GEL FOAM (GROUP I) AND 20 CASES WERE TREATED WITHOUT GEL FOAM (GROUP II) THROUGH RANDOM ALLOCATION WITHOUT SELECTION. RECURRENCE WAS ASSESSED AS PROGRESSIVE LYSIS OF 5 MM AT THE BONE CEMENT INTERFACE. FUNCTIONAL OUTCOMES WERE ASSESSED USING THE MUSCULOSKELETAL TUMOR SOCIETY SCORE (MSTS) AFTER A PERIOD OF MINIMUM 30 MONTHS. RESULTS: IN GROUP I, 18 PATIENTS (90%) HAD EXCELLENT RESULTS (RANGE 24 AND 30) ACCORDING TO MSTS AND TWO PATIENTS (10%) HAD GOOD RESULTS (RANGE 18 AND 23), WHILE IN GROUP II, 16 PATIENTS (80%) HAD EXCELLENT RESULTS AND FOUR PATIENTS (20%) HAD GOOD RESULTS. NO PATIENTS WERE GRADED AS HAVING FAIR OR POOR RESULTS. TWENTY PATIENTS (100%) HAD SATISFACTORY RESULTS, AND NO PATIENTS (0%) HAD UNSATISFACTORY RESULTS. THE OVERALL RECURRENCE RATE WAS ABOUT 15%. CONCLUSION: RECONSTRUCTION OF GCT OF BONE WITH SANDWICH TECHNIQUE OFFERS GOOD OPTION AS JOINT PRESERVING SURGERY. MOST OF THE PATIENTS GET BENEFIT IN TERMS OF BETTER QUALITY OF LIFE AND GOOD FUNCTION REGARDLESS OF AGE AND GENDER. SUBCHONDRAL BONE GRAFTING REDUCES THE EFFECT OF HEAT ON ARTICULAR CARTILAGE, BUT LONGER FOLLOW-UP IS REQUIRED. THERE IS NO BENEFIT OF GEL FOAM ADDITION IN TERMS OF FUNCTION OR ONCOLOGICAL OUTCOME NO FOLLOW-UP ATTEMPTS ARE POSSIBLE. NO FURTHER INFORMATION IS EXPECTED., COMMENT: THE EVENT ARTHRITIS IS ASSESSED AS SERIOUS, ASSOCIATED WITH THE PRODUCT ABSORBABLE GELATIN (GELFOAM), AND UNLISTED IN THE CDS OF THE PFIZER SUSPECT PRODUCT ABSORBABLE GELATIN. THIS CASE WILL BE REASSESSED WHEN ADDITIONAL INFORMATION IS RECEIVED. THE IMPACT OF THIS REPORT ON THE BENEFIT/RISK PROFILE OF THE PFIZER PRODUCT IS EVALUATED AS PART OF PFIZER PROCEDURES FOR SAFETY EVALUATION, INCLUDING THE REVIEW AND ANALYSIS OF AGGREGATE DATA FOR ADVERSE EVENTS. ANY SAFETY CONCERN IDENTIFIED AS PART OF THIS REVIEW, AS WELL AS ANY APPROPRIATE ACTION IN RESPONSE, WILL BE PROMPTLY NOTIFIED TO REGULATORY AUTHORITIES, ETHICS COMMITTEES AND INVESTIGATORS, AS APPROPRIATE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 791034 | GELFOAM | SPONGE, STERILE; CLASS III | LMF | PFIZER, INC. (DEVICE) |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 43 YR | Male | Required Intervention |