METASUL HEAD 40, 12/14, SIZE M /0
Report
- Report Number
- 0009613350-2017-00856
- Event Type
- Injury
- Date Received
- June 15, 2017
- Date of Event
- September 1, 2018
- Report Date
- July 29, 2019
- Manufacturer
- ZIMMER GMBH
- Product Code
- KWA
- Removal / Correction Number
- N/A
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- FI
- Reporter Occupation
- HEALTH PROFESSIONAL
Narratives
THIS FOLLOW-UP REPORT IS BEING FILLED TO RELAY ADDITIONAL INFORMATION. NEW INFORMATION RECEIVED: ASSOCIATED PRODUCTS ADDED. CONCOMITANT MEDICAL PRODUCTS ACCORDING D11: METASUL TAPER LINER MM/40, REF: 00-8770-014-40, LOT: 2547508. BONE SCREW SELF-TAPPING, REF: 00625006525, LOT; 61926503. BONE SCREW SELF-TAPPING, REF: 00625006535, LOT: 61687218. SHELL WITH CLUSTER HOLES, REF: 00875706001, LOT: 61920214. FEMORAL STEM 12/14 NECK TAPER, REF: 00771101300, LOT: 61548717. FEMORAL STEM 12/14 NECK TAPER, REF.:00771100600, LOT: 61772616. NEW INFORMATION DOES NOT CHANGE THE INVESTIGATION-RESULTS OF THIS INCIDENT, A FOLLOW UP REPORT WILL BE SUBMITTED WHEN ADDITIONAL INFORMATION BECOMES AVAILABLE. ZIMMER BIOMET¿S REFERENCE NUMBER OF THIS FILE IS (B)(4). THE FOLLOWING REPORTS ARE ASSOCIATED WITH THIS EVENT: 0009613350 -2017 - 00857 - 3.
THIS FOLLOW-UP REPORT IS BEING FILLED TO RELAY ADDITIONAL INFORMATION. NEW INFORMATION RECEIVED: - EVENT OCCURRED SEVEN YEARS AFTER SURGERY; - PATIENT HAS LATERAL PAIN. MRI DONE, GMI AND GME RUPTURE REPORTED; - SURGEON: DR. PETRI VIROLAINEN. THEREFORE THE CONCLUSION SUMMARY HAS BEEN UPDATED. CORRECTED AND ADDITIONAL INFORMATION IS FILLED IN THE FOLLWING FIELDS: ADDITIONAL: H2; CORRECTION: B3, B4, B5, E1, G4, G7, H10. DEVICE HISTORY RECORDS (DHR): THE DEVICE MANUFACTURING QUALITY RECORDS INDICATE THAT THE RELEASED COMPONENTS MET ALL REQUIREMENTS TO PERFORM AS INTENDED. TREND ANALYSIS: NO TRIGGER CONSIDERING THE FOLLOWING EVENT IS IDENTIFIED: PAIN. EVENT DESCRIPTION: - THE PATIENT HAD METASUL HEAD-LINER IMPLANTED ON FEBRUARY 13, 2012 AND IS MONITORED FOR FEMORAL STEM SUBSIDENCE. - ADDITIONAL INFORMATION ALSO INDICATES THAT THE PATIENT HAS LATERAL PAIN. MRI IS DONE, GMI AND GME RUPTURE WERE REPORTED. EVENT OCCURRED SEVEN YEARS AFTER SURGERY. REVIEW OF RECEIVED DATA: - CLINICAL STUDY NOTES WERE RECEIVED WHICH STATES THE 5MM SUBSIDENCE OF FEMORAL STEM. DEVICES ANALYSIS: NO PRODUCT WAS RETURNED TO ZIMMER BIOMET FOR IN-DEPTH ANALYSIS. REVIEW OF PRODUCT DOCUMENTATION: - THE COMPATIBILITY CHECK WAS PERFORMED AND SHOWED THAT THE PRODUCT COMBINATION WAS APPROVED BY ZIMMER BIOMET. ROOT CAUSE ANALYSIS: ACCORDING TO THE REPORTED EVENT PATIENT IS MONITORED DUE TO FEMORAL STEM SUBSIDENCE, WHICH DOES NOT HAVE ANY DIRECT RELATION TO DO METASUL LINER AND HEAD. CONCLUSION SUMMARY: FOR THE PAIN AND RUPTURES THAT PATIENT EXPERIENCED NO SPECIFIC RISKS CAN BE SELECTED. NEITHER X-RAYS, OPERATIVE NOTES, OFFICE VISIT NOTES, NOR DEVICES OR PHOTOS OF THE EXPLANTED IMPLANT(S) WERE RECEIVED; THEREFORE THE CONDITION OF THE COMPONENT(S) 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. IN CONCLUSION, DUE TO SIGNIFICANT LACK OF INFORMATION, IT IS IMPOSSIBLE TO PERFORM A MEANINGFUL ANALYSIS OF THE REPORTED EVENT BASED ON THE GIVEN INFORMATION AND THE RESULTS OF THE INVESTIGATION, THE COMPLAINT COULD NOT BE CONFIRMED AS THE ALLEGED FAILURE COULD NOT BE IDENTIFIED OR REPRODUCED. 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 - 2017 - 00857 - 4. NOTE: THE FOLLOWING CASE IS ASSOCIATED WITH THIS EVENT (SAME PATIENT): (B)(4).
ASSOCIATED PRODUCTS ADDED.
ADDITIONAL INFORMATION RECEIVED: ADDITIONAL INFORMATION INDICATES THAT THE PATIENT HAS LATERAL PAIN. MRI IS DONE, GMI AND GME RUPTURE WERE REPORTED. EVENT OCCURRED SEVEN YEARS AFTER SURGERY.
THE MANUFACTURER DID NOT RECEIVE X-RAYS, OR OTHER SOURCE DOCUMENTS FOR REVIEW. THE MANUFACTURER DID NOT RECEIVE THE DEVICE FOR INVESTIGATION. THE LOT NUMBER OF THE DEVICE WAS RECEIVED. 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. ADDITIONAL INFORMATION HAS BEEN REQUESTED AND IS CURRENTLY NOT AVAILABLE. (B)(4).
ADDITIONAL INFORMATION REC'D. 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. 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. TREND ANALYSIS: DURING THE TREND ANALYSIS, NO TREND WAS IDENTIFIED DEVICE HISTORY RECORDS (DHR): THE DEVICE MANUFACTURING QUALITY RECORDS INDICATE THAT THE RELEASED COMPONENTS MET ALL REQUIREMENTS TO PERFORM AS INTENDED. EVENT DESCRIPTION - EVENT SUMMARY: THE PATIENT HAD METASUL HEAD-LINER IMPLANTED ON (B)(6) 2012 AND IS MONITORED FOR FEMORAL STEM SUBSIDENCE. REVIEW OF RECEIVED DATA - CLINICAL STUDY NOTES WERE RECEIVED WHICH STATES THE 5MM SUBSIDENCE OF FEMORAL STEM DEVICES ANALYSIS NO PRODUCT WAS RETURNED TO ZIMMER BIOMET FOR IN-DEPTH ANALYSIS REVIEW OF PRODUCT DOCUMENTATION - THE COMPATIBILITY CHECK WAS PERFORMED FROM (B)(6) AND SHOWED THAT THE PRODUCT COMBINATION WAS APPROVED BY ZIMMER BIOMET. ROOT CAUSE ANALYSIS ACCORDING TO THE REPORTED EVENT PATIENT IS MONITORED DUE TO FEMORAL STEM SUBSIDENCE, WHICH DOES NOT HAVE ANY DIRECT RELATION TO DO METASUL LINER AND HEAD. HOWEVER, ALL POSSIBLE CAUSES THAT MIGHT BE LEADING TO THE ISSUES REPORTED ARE LISTED IN DFMEA CONCLUSION SUMMARY ACCORDING TO THE REPORTED EVENT PATIENT IS MONITORED DUE TO FEMORAL STEM SUBSIDENCE, WHICH DOES NOT HAVE ANY DIRECT RELATON TO DO METASUL LINER AND HEAD. HOWEVER, THE INVESTIGATION OF THE FEMORAL STEM CAN BE REACHED UNDER WARSAW SPLIT CASE (B)(4). BASED ON THE GIVEN INFORMATION AND THE RESULTS OF THE INVESTIGATION, THE COMPLAINT COULD NOT BE CONFIRMED AS THE ALLEGED FAILURE COULD NOT BE IDENTIFIED OR REPRODUCED. ZIMMER GMBH CONSIDER THIS CASE AS CLOSED ZIMMER BIOMET¿S REFERENCE NUMBER OF THIS FILE IS (B)(4).
IT WAS REPORTED THAT THE PATIENT WAS IMPLANTED AN METASUL HEAD 40, 12/14, SIZE M /0 ON THE RIGHT SIDE ON (B)(6) 2012 AND THE PATIENT UNDERWENT REVISION SURGERY ON (B)(6) 2015 DUE TO UNKNOWN REASONS.
THE REPORTED COMPLAINT IS PART OF A CLINICAL STUDY. IT WAS REPORTED THAT THE PATIENT WAS IMPLANTED A METASUL HEAD 40, 12/14, SIZE M /0 ON (B)(4) 2012. IT WAS STATED THAT SUBSIDENCE WAS NOTED BY THE PI, WITH THE DATE OF ONSET GIVEN AS (B)(6) 2012. AT THE 3 YEARS FOLLOW UP IN (B)(6) 2015 THE PATIENT REPORTS THAT HE IS SATISFIED WITH THE OUTCOME OF THE SURGERY. NO REVISION IS PLANNED. NOTE: THIS IS A SPIT COMPLAINT WITH ZIMMER INC WARSAW AND THE STEM WAS REPORTED UNDER (B)(4).
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 425311 | METASUL HEAD 40, 12/14, SIZE M /0 | METASUL HEAD | KWA | ZIMMER GMBH | N/A | 2635169 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 57 YR | Hospitalization| R | SEE H10 NARRATIVE. |