BIOLOX DELTA, CERAMIC FEMORAL HEAD, M,36/0, TAPER 12/14
Report
- Report Number
- 0009613350-2019-00410
- Event Type
- Injury
- Date Received
- July 3, 2019
- Date of Event
- January 8, 2019
- Report Date
- January 29, 2020
- Manufacturer
- ZIMMER GMBH
- Product Code
- LZO
- UDI-DI
- 00889024430365
- PMA / PMN Number
- K071535
- Removal / Correction Number
- N/A
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- US
- Reporter Occupation
- 003
Narratives
THIS CASE HAS BEEN RE-OPENED TO ENTER ADDITIONAL INFORMATION. D11: CONCOMITANT MEDICAL DEVICES: WAGNER SL REVISION HIP STEM, UNCEMENTED 18/265, TAPER 12/14; PART#: 0100102618; LOT#: 2860005. ZIMMER CONTINUUM TRILOGY LONGEVITY HIGHLY CROSSLINKED NEUTRAL LINER, CAT. NO: 00-8751-012-36, LOT NO: 63785461. ZIMMER BIOLOX DELTA CERAMIC HEAD, CAT. NO: 00-8775-036-02, LOT NO: 2898804. ZIMMER WAGNER SL REVISION HIP STEM, CAT. NO: 01.00102.618, LOT NO: 2860005. ZIMMER CABLE-READY CERCLAGE CABLE WITH CRIMP, CAT. NO: 00-2232-004-18, LOT NO: 63769061. ZIMMER CABLE-READY CERCLAGE CABLE WITH CRIMP, CAT. NO: 00-2232-004-18, LOT NO: 63769059. ZIMMER CABLE-READY CERCLAGE CABLE WITH CRIMP, CAT. NO: 00-2232-004-18, LOT NO: 63769059. ZIMMER CABLE-READY CERCLAGE CABLE WITH CRIMP, CAT. NO: 00-2232-004-18, LOT NO: 63674179. THIS ADDITIONAL INFORMATION DOES NOT CHANGE THE PREVIOUS ASSESSMENT OF THE CASE AND ZIMMER GMBH CONSIDERS THIS CASE AS CLOSED AGAIN. ZIMMER BIOMET¿S REFERENCE NUMBER OF THIS FILE IS (B)(4).
THIS FOLLOW-UP REPORT IS BEING FILLED TO RELAY INVESTIGATION RESULT. DHR REVIEW: THE DEVICE MANUFACTURING QUALITY RECORDS INDICATE THAT THE RELEASED COMPONENTS MET ALL REQUIREMENTS TO PERFORM AS INTENDED. TREND ANALYSIS: NO TREND ANALYSIS COULD BE PERFORMED AS NO SPECIFIC EVENT INFORMATION IS AVAILABLE. EVENT DESCRIPTION: IT WAS REPORTED THAT THE PATIENT HAD A SECOND REVISION SURGERY OF THE RIGHT HIP DUE TO UNKNOWN REASONS ON THE (B)(6) 2019. THE IMPLANTATION DATE IS THE (B)(6) 2018 (ALSO DATE OF FIRST REVISION SURGERY. REASONS UNKNOWN. PRIMARY IMPLANTATION IS THE (B)(6) 2017). THE THEN IMPLANTED BIOLOX HEAD HAS BEEN REVISED, AS WELL AS THE INLAY (WARSAW PRODUCT). REVIEW OF RECEIVED DATA: INTERNAL E-MAIL FROM LEGAL DEPARTMENT INFORMING ABOUT A NEW CLAIM. DEVICE ANALYSIS: NO PRODUCT WAS RETURNED TO ZIMMER BIOMET FOR IN-DEPTH ANALYSIS. REVIEW OF PRODUCT DOCUMENTATION: ALL INVOLVED DEVICES ARE INTENDED FOR TREATMENT. THE COMPATIBILITY CHECK WAS PERFORMED AND SHOWED THAT THE PRODUCT COMBINATION WAS APPROVED BY ZIMMER BIOMET. INSTRUCTION FOR USE (IFU) FOR ENDOPROSTHESIS LISTS GENERAL INSTRUCTIONS, RISK FACTORS, STERILIZATION INSTRUCTIONS, STORAGE AND HANDLING INSTRUCTIONS. HOWEVER, AS NO SURGICAL REPORT AND NO ADDITIONAL RELEVANT INFORMATION IS AVAILABLE, COMPARISON OF THE IFU AND THE APPROACH APPLIED COULD NOT BE PERFORMED. CONCLUSION: NEITHER X-RAYS, OPERATIVE NOTES, OFFICE VISIT NOTES, NOR DEVICES OR PHOTOS OF THE EXPLANTED IMPLANTS WERE RECEIVED; THEREFORE THE CONDITION OF THE COMPONENT IS UNKNOWN. THE NATURE OF THE COMPLAINT 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 QUALITY RECORDS SHOW THAT ALL SPECIFIED CHARACTERISTICS (MATERIAL, DIMENSIONS, SURFACE, ETC.) HAVE MET THE SPECIFICATIONS VALID AT THE TIME OF PRODUCTION. 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. IF ADDITIONAL INFORMATION BECOMES AVAILABLE, THEN THE COMPLAINT AND ITS INVESTIGATION WILL BE REASSESSED. BASED ON THE AVAILABLE INFORMATION, AN EXACT ROOT CAUSE COULD NOT BE DETERMINED. INVESTIGATION INVOLVING WARSAW PRODUCTS IS REGISTERED UNDER (B)(4) (1ST REVISION) AND (B)(4) (2ND REVISION - WARSAW LINER). 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).
NO EVENT UPDATE.
PLEASE REFER TO REPORT 0009613350-2019-00410.
CONCOMITANT MEDICAL DEVICE: WAGNER SL REVISION HIP STEM, UNCEMENTED 18/265, TAPER 12/14; PART# 0100102618; LOT# 2860005 THERAPY DATE: (B)(6) 2019. THE MANUFACTURER DID NOT RECEIVE X-RAYS, OR OTHER SOURCE DOCUMENTS FOR REVIEW. THE MANUFACTURER DID NOT RECEIVE THE DEVICE FOR INVESTIGATION. THE DEVICE HISTORY RECORDS WERE REVIEWED AND FOUND TO BE CONFORMING. ADDITIONAL INFORMATION HAS BEEN REQUESTED AND IS CURRENTLY NOT AVAILABLE. 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).
PATIENT WAS IMPLANTED ON THE RIGHT SIDE AND UNDERWENT REVISION DUE TO UNKNOWN REASONS.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 551993 | BIOLOX DELTA, CERAMIC FEMORAL HEAD, M,36/0, TAPER 12/14 | BIOLOXDELTA, CERAMIC FEMORAL HEAD | LZO | ZIMMER GMBH | N/A | 2898804 | 00889024430365 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Hospitalization| R | SEE H10 NARRATIVE| SEE H10 NARRATIVE |