METASUL LDH, HEAD, 56, CODE V, TAPER 18/20
Report
- Report Number
- 0009613350-2018-00208
- Event Type
- Injury
- Date Received
- January 31, 2018
- Date of Event
- March 5, 2014
- Report Date
- August 3, 2018
- Manufacturer
- ZIMMER GMBH
- Product Code
- KWY
- PMA / PMN Number
- PN/A
- Removal / Correction Number
- N/A
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- UK
- Reporter Occupation
- OTHER
Narratives
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: NJR INFORMED ZIMMER BIOMET ABOUT CERTAIN PATIENT'S EXPERIENCES WITH ALLOCLASSIC SL STEMS RESULTED IN REVISION SURGERIES. THE CASE AT HAND TREATS THE EXPERIENCE OF A 67 YEARS OLD MALE PATIENT. THE PATIENT WAS REVISED AROUND 7 YEARS AND 9 MONTHS POST IMPLANTATION DUE TO INFECTION AND OTHER INDICATION. REVIEW OF RECEIVED DATA: NO MEDICAL DATA SUCH AS X-RAYS, SURGICAL NOTES OR ANY OTHER CASE-RELEVANT DOCUMENTS RECEIVED. DEVICES ANALYSIS: NO PRODUCT WAS RETURNED TO ZIMMER BIOMET FOR IN-DEPTH ANALYSIS. REVIEW OF PRODUCT DOCUMENTATION: THE COMPATIBILITY CHECK WAS PERFORMED FROM WWW.PRODUCTCOMPATIBILITY.ZIMMER.COM AND SHOWED THAT THE PRODUCT COMBINATION WAS APPROVED BY ZIMMER BIOMET. ROOT CAUSE DETERMINATION FOR "INFECTION" FOR THE ALLOCLASSIC, SL STEM USING RMW: BIOLOGICAL CONTAMINATED DEVICE IS IMPLANTED DUE TO CLEANING PROCESS FAILURE NOT POSSIBLE: THE GAMMA STERILIZATION SPECIFICATION OF THE DEVICE CERTIFIES THE SUITABILITY OF STERILIZATION. THE IRRADIATION CERTIFICATE OF THE AFFECTED LOT HAS BEEN REVIEWED AND WAS FOUND TO BE ACCORDING TO SPECIFICATION. THEREFORE, THIS CAUSE CAN BE EXCLUDED. BIOLOGICAL CONTAMINATED DEVICE IS IMPLANTED DUE TO STERILIZATION PROCESS FAILURE NOT POSSIBLE : THE GAMMA STERILIZATION SPECIFICATION OF THE DEVICE CERTIFIES THE SUITABILITY OF STERILIZATION. THE IRRADIATION CERTIFICATE OF THE AFFECTED LOT HAS BEEN REVIEWED AND WAS FOUND TO BE ACCORDING TO SPECIFICATION. THEREFORE, THIS CAUSE CAN BE EXCLUDED. BIOLOGICAL CONTAMINATED DEVICE IS IMPLANTED DUE TO CONTAMINATED DEVICE DUE TO PACKAGING FAILURE NOT POSSIBLE: A SYSTEMATIC ISSUE WITH THE PACKAGING DESIGN WOULD HAVE BEEN DETECTED AS PART OF THE ISSUE EVALUATION ASSESSMENT. BIOLOGICAL CONTAMINATED DEVICE IS IMPLANTED DUE TO INADEQUATE TRANSPORT/HANDLING/STORAGE CONDITION: POSSIBLE, THE HANDLING AND STORAGE OF THE COMPONENT IS OUTSIDE OF ZIMMER BIOMET CONTROL. THEREFORE, THIS CAUSE CANNOT BE EXCLUDED. BIOLOGICAL CONTAMINATED DEVICE IS IMPLANTED DUE TO EXPLANTED IMPLANT IS USED FOR NEW IMPLANTATION SURGERY NOT POSSIBLE: NO INFORMATION RECEIVED, THAT A SINGLE USE DEVICE WAS REUSED. THEREFORE, THIS CAUSE CAN BE EXCLUDED. ROOT CAUSE DETERMINATION FOR "INFECTION" FOR THE METASUL DUROM, COMPONENT FOR ACETABULUM, USING DFMEA: SEPTIC LOOSENING DUE TO INFECTION THROUGH CONTAMINATED IMPLANT: NOT POSSIBLE: THE GAMMA STERILIZATION SPECIFICATION OF THE DEVICE CERTIFIES THE SUITABILITY OF STERILIZATION. THE IRRADIATION CERTIFICATE OF THE AFFECTED LOT HAS BEEN REVIEWED AND WAS FOUND TO BE ACCORDING TO SPECIFICATION. THEREFORE, THIS CAUSE CAN BE EXCLUDED. SEPTIC LOOSENING DUE TO SURGEON IMPLANTS A DEVICE ALTHOUGH THE EXPIRATION DATE HAS BEEN REACHED: NOT POSSIBLE: THE EXPIRATION DATE OF THE DEVICE WAS NOT REACHED. THEREFORE, THIS CAUSE CAN BE EXCLUDED. SEPTIC LOOSENING DUE TO IMPLANT CONTAMINATED DURING OR, RESTERILIZATION: POSSIBLE: THE HANDLING OF THE COMPONENT IS OUTSIDE OF ZIMMER BIOMET CONTROL. THEREFORE, THIS CAUSE CANNOT BE EXCLUDED. ROOT CAUSE DETERMINATION FOR "INFECTION" FOR THE METASUL LDH, HEAD USING DFMEA: INFECTION DUE TO NON STERILE HEAD IMPLANT DUE TO INCORRECT STERILIZATION METHOD: NOT POSSIBLE: THE GAMMA STERILIZATION SPECIFICATION OF THE DEVICE CERTIFIES THE SUITABILITY OF STERILIZATION. THE IRRADIATION CERTIFICATE OF THE AFFECTED LOT HAS BEEN REVIEWED AND WAS FOUND TO BE ACCORDING TO SPECIFICATION. THEREFORE, THIS CAUSE CAN BE EXCLUDED. INFECTION DUE TO NON STERILE HEAD IMPLANT DUE TO INADEQUATE PACKAGING: NOT POSSIBLE: A SYSTEMATIC ISSUE WITH THE PACKAGING DESIGN WOULD HAVE BEEN DETECTED AS PART OF THE ISSUE EVALUATION ASSESSMENT. THEREFORE, THIS CAUSE CAN BE EXCLUDED. UNSTERILE PRODUCT DUE IMPROPER HANDLING DURING SURGERY DUE TO UNSAFE USE OF DEVICE, INJURY OF PATIENT, SURGEON, OR- OR WORKSHOP-STAFF: POSSIBLE: THE HANDLING OF THE COMPONENT IS OUTSIDE OF ZIMMER BIOMET CONTROL. THEREFORE, THIS CAUSE CANNOT BE EXCLUDED. REGARDING THE EVENT " REVISED DUE TO OTHER INDICATION": AS THIS IS NOT A SPECIFIC FAILURE MODE, A ROOT CAUSE ANALYSIS S FOR THAT COULD THEREFORE NOT BE PERFORMED. CONCLUSION SUMMARY: IT WAS REPORTED BY NJR THAT A PATIENT UNDERWENT A REVISION SURGERY 7 YEARS AND 9 MONTHS POST IMPLANTATION DUE TO INFECTION AND "OTHER INDICATION". NEITHER X-RAYS, OPERATIVE NOTES, OFFICE VISIT NOTES, NOR THE DEVICE OR PHOTOS OF THE EXPLANTED IMPLANT WERE RECEIVED; THEREFORE THE CONDITION OF THE COMPONENT IS UNKNOWN. PATIENT FACTORS THAT MAY AFFECT THE PERFORMANCE OF THE COMPONENTS SUCH AS BONE QUALITY, ACTIVITY LEVEL, TYPE OF ACTIVITY (LOW IMPACT VS. HIGH IMPACT), AND RELEVANT MEDICAL HISTORY ARE UNKNOWN. ADHERENCE TO REHABILITATION PROTOCOL IS UNKNOWN. THE GAMMA STERILIZATION SPECIFICATION OF THE DEVICES CERTIFIES THE SUITABILITY OF STERILIZATION. THE IRRADIATION CERTIFICATES OF THE AFFECTED LOTS HAVE BEEN REVIEWED AND WERE FOUND TO BE ACCORDING TO SPECIFICATION. THEREFORE, IT CAN BE EXCLUDED THAT AN UNSTERILE DEVICE CAUSED THE INFECTION. MOREOVER, NO TREND ON INFECTION HAS BEEN OBSERVED FOR THIS PRODUCT FAMILY. THEREFORE, IT IS HIGHLY UNLIKELY THAT A DISADVANTAGEOUS PRODUCT DESIGN FAVORED OR CONTRIBUTED TO THE INFECTION. HOWEVER, THE APPROPRIATES IFUS FOR THE ENDOPROSTHESIS STATE THAT ¿EARLY OR LATE INFECTIONS¿ ARE ¿POSSIBLE CONSEQUENCES OF AN IMPLANT¿ AND SHOULD BE CONSIDERED WHEN IMPLANTING ZIMMER BIOMET DEVICES. IN CONCLUSION, DUE TO SIGNIFICANT LACK OF INFORMATION, IT IS IMPOSSIBLE TO PERFORM A MEANINGFUL ANALYSIS OF THE REPORTED EVENT. THEREFORE, AN EXACT ROOT CAUSE CANNOT BE DETERMINED. 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).
CONCOMITANT MEDICAL PRODUCTS: ITEM: METASUL DUROM, COMPONENT FOR ACETABULUM, UNCEM. 62¸ 56, CATALOG #: 01.00214.062, LOT #: 2316614; ITEM: ALLOCLASSIC, SL STEM, OFFSET, UNCEMENTED, 6, TAPER 12/14, CATALOG #: 01.00121.060, LOT #: 2303095. THE DEVICE WILL NOT BE RETURNED FOR ANALYSIS; HOWEVER, AN INVESTIGATION OF THE REPORTED EVENT IS IN PROGRESS. ONCE THE INVESTIGATION IS COMPLETED, A SUPPLEMENTAL MEDWATCH 3500A WILL BE SUBMITTED. THE MANUFACTURER DID NOT RECEIVE X-RAYS, OR OTHER SOURCE DOCUMENTS FOR REVIEW. THE DEVICE HISTORY RECORDS WERE REVIEWED AND FOUND TO BE CONFORMING. 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. THIS PRODUCT IS MANUFACTURED BY ZIMMER BIOMET (B)(6) AND IS NOT CLEARED OR DISTRIBUTED IN THE U.S. HOWEVER, THIS REPORT IS BEING SUBMITTED AS ZIMMER BIOMET (B)(6) MANUFACTURES A SIMILAR DEVICE THAT IS CLEARED OR DISTRIBUTED IN THE UNITED STATES UNDER 510(K) NUMBER K091973. ZIMMER BIOMET¿S REFERENCE NUMBER OF THIS FILE IS (B)(4).
IT WAS REPORTED THAT THE PATIENT HAD A REVISION SURGERY APPROXIMATELY SEVEN YEARS POST IMPLANTATION DUE TO INFECTION AND OTHER INDICATION. ATTEMPTS TO OBTAIN ADDITIONAL INFORMATION HAVE BEEN MADE; HOWEVER, NO MORE IS AVAILABLE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 74996 | METASUL LDH, HEAD, 56, CODE V, TAPER 18/20 | N/A | KWY | ZIMMER GMBH | N/A | 2357629 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 67 YR | Hospitalization| R |