REVITAN, DISTAL PART, CURVED, UNCEMENTED, 18/260
Report
- Report Number
- 0009613350-2019-00002
- Event Type
- Injury
- Date Received
- January 10, 2019
- Date of Event
- May 30, 2018
- Report Date
- January 22, 2020
- Manufacturer
- ZIMMER GMBH
- Product Code
- LZO
- PMA / PMN Number
- N/A
- Removal / Correction Number
- N/A
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- GM
- Reporter Occupation
- 003
Narratives
ADDITIONAL INFORMATION WERE RECEIVED. CONCOMITANT DEVICES: REVITAN, PROXIMAL PART, CYLINDRICAL, UNCEMENTED, 105, TAPER 12/14, ITEM# 01.00402.105 , LOT# 2931500. BIOLOX DELTA, CERAMIC FEMORAL HEAD, XL, 32/+7, TAPER 12/14, ITEM# 00-8775-032-04, LOT# 2935301. X-RAYS AND SURGICAL REPORTS WERE RECEIVED AND WILL BE REVIEWED WITHIN INVESTIGATION. WHERE LOT NUMBERS WERE RECEIVED FOR THE DEVICES, THE DEVICE HISTORY RECORDS WERE REVIEWED AND FOUND TO BE CONFORMING. AS SOON AS SUPPLEMENTAL INFORMATION BECOMES AVAILABLE AN UPDATED REPORT WILL BE SUBMITTED. ZIMMER BIOMET¿S REFERENCE NUMBER OF THIS FILE IS (B)(4).
ADDITIONAL INFORMATION WAS RECEIVED D11, CONCOMITANT MEDICAL DEVICES: UNKNOWN REVITAN PROXIMAL STEM, ITEM# AND LOT# UNKNOWN, UNKNOWN BIOLOX HEAD, ITEM# AND LOT# UNKNOWN. 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. ZIMMER BIOMET¿S REFERENCE NUMBER OF THIS FILE IS (B)(4).
DEVICE HISTORY RECORDS (DHR): THE DEVICE MANUFACTURING QUALITY RECORDS INDICATE THAT THE RELEASED COMPONENTS MET ALL REQUIREMENTS TO PERFORM AS INTENDED. NO TREND CONSIDERING THE FOLLOWING EVENT IS IDENTIFIED: INFECTION. EVENT SUMMARY: IT WAS REPORTED IN A LEGAL WRIT THAT THE PATIENT P.V. EXPERIENCED RIGHT AFTER A PROCEDURE PERFORMED ON (B)(6) 2018 THAT THE LESION WAS INFECTED AND AN UNKNOWN SURGICAL TREATMENT WAS PERFORMED ON (B)(6) 2018 INCLUDING MICROBIOLOGICAL AND HISTOPATHOLOGICAL EXAMINATION, ANTIBIOSIS THERAPY, CATHETER (CVC) AND BLOOD TRANSFUSION. FOLLOWING, ANTIBIOTICS TREATMENT FOR ONE YEAR WITH AMOXICILLIN IN COMBINATION WITH CONTINUOUS CLINICAL MONITORING. REVIEW OF RECEIVED DATA A LEGAL WRIT WAS RECEIVED ON DEC 13, 2018 WHICH MENTIONS THAT THE PATIENT EXPERIENCED RIGHT AFTER A PROCEDURE PERFORMED ON (B)(6) 2018 THAT THE LESION WAS INFECTED AND A SURGICAL TREATMENT WAS PERFORMED ON (B)(6) 2018 INCLUDING MICROBIOLOGICAL AND HISTOPATHOLOGICAL EXAMINATION, ANTIBIOSIS THERAPY, CATHETER (CVC) AND BLOOD TRANSFUSION. THE PATIENT HAS TO TAKE ANTIBIOTICS TREATMENT FOR ONE YEAR WITH AMOXICILLIN IN COMBINATION WITH CONTINUOUS CLINICAL MONITORING. 18 X-RAYS WERE RECEIVED FOR THIS PATIENT, HOWEVER, THESE ARE NOT RELEVANT FOR THIS CASE. TWO SURGICAL REPORTS, DATED DEC 05, 2015 AND APR 30, 2018 WERE RECEIVED FOR THIS PATIENT, HOWEVER, DETAILS ARE NOT RELEVANT FOR THIS CASE. A SUMMARY OF THE COURSE OF EVENTS WAS RECEIVED. OTHERWISE, NO RELEVANT MEDICAL DOCUMENTATION RECEIVED FOR THIS CASE. DEVICES ANALYSIS NO PRODUCT WAS RETURNED TO ZIMMER BIOMET FOR IN-DEPTH ANALYSIS AS THEY REMAIN IMPLANTED. REVIEW OF PRODUCT DOCUMENTATION: THE PRODUCT COMBINATION WAS APPROVED BY ZIMMER BIOMET, CHECK WAS PERFORMED FROM WWW.PRODUCTCOMPATIBILITY.ZIMMER.COM AND BY SURGICAL TECHNIQUE. REVIEW OF THE STERILIZATION CERTIFICATES SHOWED THAT THE STERILIZATION OF EACH DEVICE WAS PERFORMED WITHOUT ANY REPORTED ANOMALIES. CONCLUSION SUMMARY: THE PATIENT (B)(6) UNDERWENT MULTIPLE PROCEDURES INCLUDING REVISIONS AND CLOSED REDUCTIONS BETWEEN 2015 AND (B)(6) 2018. ON (B)(6) 2018 THE REVITAN STEM AS WELL AS THE BIOLOX HEAD WAS REVISED. FOLLOWING THE PATIENT EXPERIENCED MULTIPLE DISLOCATIONS. ON (B)(6) 2018 THE SHELL AND THE HEAD WERE REVISED. RIGHT AFTER THIS PROCEDURE, AS REPORTED BY THE RECEIVED LEGAL WRIT, THE LESION WAS INFECTED AND AN UNKNOWN SURGICAL TREATMENT WAS PERFORMED ON (B)(6) 2018 INCLUDING MICROBIOLOGICAL AND HISTOPATHOLOGICAL EXAMINATION, ANTIBIOSIS THERAPY, CATHETER (CVC) AND BLOOD TRANSFUSION. FOLLOWING, ANTIBIOTICS TREATMENT FOR ONE YEAR WITH AMOXICILLIN IN COMBINATION WITH CONTINUOUS CLINICAL MONITORING WAS PRESCRIBED. THIS COMPLAINT COVERS THE STERILIZATION OF THE REVITAN COMPONENTS AND THE BIOLOX HEAD IMPLANTED ON (B)(6) 2018, AS THEY WERE IMPLANTED WITHIN SHORT TIME PRIOR TO THE REPORTED INFECTION. THE PRODUCTS IMPLANTED, RIGHT BEFORE THE REPORTED INFECTION, ON (B)(6) 2018 ARE COVERED IN (B)(4) (BFARM REF (B)(4)). NO CASE-RELEVANT DOCUMENTATION, SUCH AS SURGICAL REPORTS OF RELEVANT PROCEDURES OR LABORATORY TEST REPORTS, WAS RECEIVED FOR REVIEW. THE QUALITY RECORDS SHOW THAT ALL SPECIFIED CHARACTERISTICS OF THE PRODUCTS HAVE MET THE SPECIFICATIONS VALID AT THE TIME OF PRODUCTION. FURTHER, THE GAMMA STERILIZATION SPECIFICATION OF THE DEVICE CERTIFIES THE SUITABILITY OF STERILIZATION. THE IRRADIATION CERTIFICATE OF THE AFFECTED LOTS HAS BEEN REVIEWED AND WERE FOUND TO BE ACCORDING TO SPECIFICATION. MOREOVER, NO TREND ON INFECTION HAS BEEN OBSERVED FOR ANY OF THE PRODUCTS SUBJECT TO THIS COMPLAINT. THEREFORE, IT IS HIGHLY UNLIKELY THAT A DISADVANTAGEOUS PRODUCT DESIGN FAVORED OR CONTRIBUTED TO THE INFECTION. NEVERTHELESS, THE IFU FOR ENDOPROSTHESIS STATES THAT EARLY OR LATE INFECTIONS ARE POSSIBLE CONSEQUENCES OF AN IMPLANT AND SHOULD BE CONSIDERED WHEN IMPLANTING ZIMMER BIOMET DEVICES. THEREFORE, BASED ON THE LACK OF MEDICAL DOCUMENTATION THAT COULD CONFIRM THE INFECTION OF THE LESION AND BASED ON THE REVIEW OF THE STERILIZATION CERTIFICATES WE CONCLUDE THAT THE REPORTED INFECTION OF THE LESION WAS MOST LIKELY NOT DEVICE RELATED. 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). THE FOLLOWING REPORTS ARE ASSOCIATED WITH THIS EVENT: 0009613350-2019-00002, 0009613350-2019-00001, 0009613350-2019-00003.
THIS CASE WAS REOPENED AS NEW INFORMATION HAS BEEN RECEIVED AND THE INVESTIGATION RESUTLS HAVE BEEN UPDATED. REVIEW OF RECEIVED DATA (UPDATED): A LEGAL WRIT WAS RECEIVED ON DEC 13, 2018 WHICH MENTIONS THAT THE PATIENT EXPERIENCED RIGHT AFTER A PROCEDURE PERFORMED ON (B)(6) 2018 THAT THE LESION WAS INFECTED AND A SURGICAL TREATMENT WAS PERFORMED ON (B)(6) 2018 INCLUDING MICROBIOLOGICAL AND HISTOPATHOLOGICAL EXAMINATION, ANTIBIOSIS THERAPY, CATHETER (CVC) AND BLOOD TRANSFUSION. THE PATIENT HAS TO TAKE ANTIBIOTICS TREATMENT FOR ONE YEAR WITH AMOXICILLIN IN COMBINATION WITH CONTINUOUS CLINICAL MONITORING. 18 X-RAYS WERE RECEIVED FOR THIS PATIENT, HOWEVER, THESE ARE NOT RELEVANT FOR THIS CASE. TWO SURGICAL REPORTS, DATED (B)(6) 2015 AND (B)(6) 2018 WERE RECEIVED FOR THIS PATIENT, HOWEVER, DETAILS ARE NOT RELEVANT FOR THIS CASE. A SUMMARY OF THE COURSE OF EVENTS WAS RECEIVED. FROM THE SURGICAL REPORTS, THE LEGAL WRIT AND A RECEIVED CASE SUMMARY THE FOLLOWING COURSE OF EVENTS IS DESCRIBED: 2005: INITIAL LEFT HIP TEP WITH UNKNOWN DEVICES. (B)(6) 2015: PATIENT FALL ON LEFT HIP. (B)(6) 2015: REMOVAL OF LEFT HIP TEP AND REPLACEMENT WITH CEMENT SPACER (GIRDLESTONE SITUATION) DUE TO INFECTION. (B)(6) 2015: INFECTION AND OUTBURST OF CEMENT SPACER. (B)(6) 2015: OPEN BIOPSY, DEBRIDEMENT AND LAVAGE, NO INDICATION FOR INFECTION. (B)(6) 2015: IMPLANTATION OF HYPERION REVISION HIP TEP (WARSAW PRODUCTS: HYPERION STEM, BIOLOX DELTA, ACETABULAR LINER, ACETABULAR G7 SHELL) (B)(6) 2015: REVISION OF HYPERION STEM AND HEAD DUE TO LUXATION, STEM LOOSENING AND PERIPROSTHETIC FRACTURE (B)(4). IMPLANTATION OF ANOTHER HYPERION STEM, ACETABULAR LINER, BIOBALL ADAPTER AND BIOBALL DELTA CERAMIC HEAD AND WIRE CERCLAGE. (B)(6) 2018: IMPLANT FRACTURE OF HYPERION STEM DUE TO TRAUMA (TWISTING MOTION) (B)(4) NOTICED. (B)(6) 2018: REVISION OF FRACTURED HYPERION STEM (B)(4) TO A REVITAN SYSTEM (REVITAN PROX, REVITAN DIST. CURVED, BIOLOX DELTA HEAD). (B)(6) 2018: REVISION OF REVITAN SYSTEM DUE TO STEM SINTERING (B)(4). IMPLANTATION OF ANOTHER REVITAN SYSTEM AND A BIOLOX HEAD. (B)(6) 2018: CLOSED REPOSITION DUE TO TRAUMA (TWISTING MOTION) (B)(4). (B)(6) 2018: REVISION OF ACETABULAR SHELL AND HEAD DUE TO RECURRING LUXATIONS (B)(4) IMPLANTATION OF AN AVANTAGE ACETABULAR CUP, BIOLOX OPTION TAPER, BIOLOX DELTA HEAD, TRABECULAR METAL SHELL AND MULTIPLE BONE SCREWS. (B)(6) 2018: SURGERY DUE TO INFECTION OF THE LESION WITH MICROBIOLOGICAL AND HISTOPATHOLOGICAL INVESTIGATION (B)(4). (B)(6) 2018: FOLLOW-UP CHECK: NO INDICATION FOR INFECTION, ON-GOING ANTIBIOSIS, FULL WEIGHT BEARING. (B)(6) 2018: FOLLOW-UP CHECK: NO INDICATION FOR INFECTION, ON-GOING ANTIBIOSIS, FULL WEIGHT BEARING (B)(4). A REDUNDANCY LETTER (MAINZ, JUN 19, 2018) WAS RECEIVED: ACCORDING TO THE LETTER, THE PATIENT EXPERIENCED AN INFECTION OF THE LEFT HIP TEP WITH ENTEROCOCCUS FAECALIS AND STAPHYLOCOCCUS EPIDERMIS. ON (B)(6) 2018 A REVISION CONSISTING OF DEBRIDMENT AND JET-LAVAGE WITH LAVASEPT HAS BEEN PERFORMED. MICROBIOLOGICAL FINDINGS: (B)(6) 2018: ENTEROCOCCUS FAECALIS AND STAPHYLOCOCCUS EPIDERMIS. (B)(6) 2018: ENTEROCOCCUS FAECALIS AND STAPHYLOCOCCUS EPIDERMIS. THE SURGICAL REPORT OF THE SURGERY ON MAY 28, 2018 DUE TO RECURRENT LUXATIONS HAS BEEN RECEIVED: NO INFORMATION ABOUT THE CONSEQUENT INFECTION. THE SURGICAL REPORT OF THE SURGERY ON (B)(6) 2018 HAS BEEN RECEIVED: DIAGNOSIS: HIP TEP INFECTION WITH ENTEROCOCCUS FAECALIS AFTER MULTIPLE REVISIONS TREATMENT: REVISION, DEBRIDMENT, JET-LAVGE WITH LAVASEPT INDICATION: AFTER THE LAST REVISION SURGERY, THE MICROBIOLOGICAL EVALUATION SHOWED AN INFECTION WITH ENTEROCOCCUS FAECALIS. THESE GERMS HAVE ALREADY BEEN FOUND IN 2015, DUE TO WHICH THIS REVISION SURGERY IS PERFORMED TO REDUCE THE GERM LOAD. DESCRIPTION OF PROCEDURE: OPENING OF THE SCAR. DEBRIDMENT OF SUBCUTANEOUS TISSUE, WHERE NO INDICATION OF INFECTION CAN BE FOUND. REMOVAL OF THE SUTURES AND SEPARATION OF THE FASCIA. HERE A HAEMATOMA CAN BE FOUND, HOWEVER, AGAIN WITHOUT INDICATION OF INFECTION. DISPLAY OF THE PROSTHESIS, AGAIN WITHOUT INDICATION OF INFECTION. DEBRIDMENT AND CLOSURE. CONCLUSION SUMMARY (UPDATED): THE PATIENT P.V. UNDERWENT MULTIPLE PROCEDURES INCLUDING REVISIONS AND CLOSED REDUCTIONS BETWEEN 2015 AND (B)(6) 2018. ON (B)(6) 2018 THE REVITAN STEM AS WELL AS THE BIOLOX HEAD WAS REVISED. FOLLOWING THE PATIENT EXPERIENCED MULTIPLE DISLOCATIONS. ON (B)(6) 2018 THE SHELL AND THE HEAD WERE REVISED. RIGHT AFTER THIS PROCEDURE, AS REPORTED BY THE RECEIVED LEGAL WRIT, THE LESION WAS INFECTED AND A REVISION SURGERY CONSISTING OF DEBRIDMENT AND JET-LAVAGE WAS PERFORMED ON (B)(6) 2018 INCLUDING MICROBIOLOGICAL AND HISTOPATHOLOGICAL EXAMINATION, ANTIBIOSIS THERAPY, CATHETER (CVC) AND BLOOD TRANSFUSION. FOLLOWING, ANTIBIOTICS TREATMENT FOR ONE YEAR WITH AMOXICILLIN IN COMBINATION WITH CONTINUOUS CLINICAL MONITORING WAS PRESCRIBED. THIS COMPLAINT COVERS THE STERILIZATION OF THE REVITAN COMPONENTS AND THE BIOLOX HEAD IMPLANTED ON (B)(6) 2018, AS THEY WERE IMPLANTED WITHIN SHORT TIME PRIOR TO THE REPORTED INFECTION. THE PRODUCTS IMPLANTED ON (B)(6) 2018 ARE COVERED IN (B)(4). THE SURGICAL REPORT OF THE REVISION SURGERY PERFORMED ON (B)(6) 2018 DESCRIBES THE INFECTION OF THE HIP TEP WITH ENTEROCOCCUS FAECALIS, WHICH HAS ALREADY BEEN THE CASE IN 2015. A DEBRIDMENT AND JET-LAVAGE WITH LAVASEPT WAS PERFORMED. AS DESCRIBED IN THE SURGICAL REPORT NO MACROSCOPICAL INDICATION FOR INFECTION WAS FOUND IN THE SUBCUTANEOUS TISSUE, IN THE FASCIA OR ON THE PROSTHESIS. NO PARTS WERE REVISED DURING THIS SURGERY. IN THE REDUNDANCY LETTER FROM JUN 19, 2018 NOT ONLY THE MICROBIOLOGICAL FINDING OF ENTEROCOCCUS FAECALIS BUT ALSO OF STAPHYLOCOCCUS EPIDERMIS IS DESCRIBED. THE QUALITY RECORDS SHOW THAT ALL SPECIFIED CHARACTERISTICS OF THE PRODUCTS (REVITAN DISTAL, REVITAN PROXIMAL AND BIOLOX HEAD) HAVE MET THE SPECIFICATIONS VALID AT THE TIME OF PRODUCTION. FURTHER, THE GAMMA STERILIZATION SPECIFICATION OF THE DEVICE CERTIFIES THE SUITABILITY OF STERILIZATION. THE IRRADIATION CERTIFICATES OF THE LOTS HAVE BEEN REVIEWED AND WERE FOUND TO BE ACCORDING TO SPECIFICATION. MOREOVER, NO TREND ON INFECTION HAS BEEN OBSERVED FOR ANY OF THE PRODUCTS SUBJECT TO THIS COMPLAINT. THEREFORE, IT IS HIGHLY UNLIKELY THAT A DISADVANTAGEOUS PRODUCT DESIGN FAVORED OR CONTRIBUTED TO THE INFECTION. NEVERTHELESS, THE IFU FOR ENDOPROSTHESIS STATES THAT EARLY OR LATE INFECTIONS ARE POSSIBLE CONSEQUENCES OF AN IMPLANT AND SHOULD BE CONSIDERED WHEN IMPLANTING ZIMMER BIOMET DEVICES. IT IS POSSIBLE THAT THE PATIENT WAS AT HIGHER RISK FOR INFECTION DUE TO REPEATED SURGERIES IN COMBINATION WITH A REDUCED IMMUNE RESISTANCE DUE TO THE PREVIOUS SURGICAL AND MEDICAL TREATMENTS. THEREFORE, BASED ON THE GIVEN INFORMATION AND THE STERILIZATION CERTIFICATES WE CONCLUDE THAT THE REPORTED INFECTION OF THE LESION WAS MOST LIKELY NOT DEVICE RELATED. NEVERTHELESS, AN EXACT ROOT CAUSE COULD NOT BE DETERMINED. THE NEED FOR CORRECTIVE MEASURES IS NOT INDICATED AND ZIMMER GMBH CONSIDERS THIS CASE AS CLOSED AGAIN. ZIMMER BIOMET¿S REFERENCE NUMBER OF THIS FILE IS (B)(4).
NO EVENT UPDATE.
NO EVENT UPDATE.
A PRODUCT LIABILITY CLAIM WAS RAISED. IT WAS REPORTED THAT THE PATIENT HAD AN INFECION WHICH HAD TO BE TREATED TWO DAYS AFTER REVISION SURGERY.
NO EVENT UPDATE.
CONCOMITANT MEDICAL PRODUCTS: THERAPY DATE: (B)(6) 2018. THE MANUFACTURER DID NOT RECEIVE X-RAYS, OR OTHER SOURCE DOCUMENTS FOR REVIEW. 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. (B)(4).
PATIENT WAS IMPLANTED ON UNKNOWN SIDE AND UNDERWENT REVISION DUE TO INFECTION.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 25459 | REVITAN, DISTAL PART, CURVED, UNCEMENTED, 18/260 | REVITAN DISTAL STEM | LZO | ZIMMER GMBH | N/A | 2925539 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Hospitalization| R |