BIOLOX DELTA, CERAMIC FEMORAL HEAD, M, 36/0, TAPER 12/14
Report
- Report Number
- 0009613350-2018-00362
- Event Type
- Injury
- Date Received
- March 16, 2018
- Date of Event
- February 20, 2018
- Report Date
- October 25, 2018
- Manufacturer
- ZIMMER GMBH
- Product Code
- LZO
- PMA / PMN Number
- PK071535
- Removal / Correction Number
- N/A
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- US
- Reporter Occupation
- PHYSICIAN
Narratives
INVESTIGATION RESULTS WERE MADE AVAILABLE. DEVICE HISTORY RECORDS (DHR): THE DEVICE MANUFACTURING QUALITY RECORDS INDICATE THAT THE RELEASED COMPONENTS MET ALL REQUIREMENTS TO PERFORM AS INTENDED. TREND ANALYSIS: NO TREND CONSIDERING THE FOLLOWING EVENT IS IDENTIFIED: STEM NECK FRACTURE. REVIEW OF EVENT DESCRIPTION: THE PATIENT WAS IMPLANTED WITH A RIGHT HIP TEP ON (B)(6) 2015. FOLLOWING, THE PATIENT UNDERWENT A REVISION SURGERY ON (B)(6) 2018 DUE TO NECK FRACTURE OF THE IMPLANTED STEM. DURING REVISION SURGERY THE STEM AND THE MOUNTED BIOLOX HEAD WERE REVISED, THE SHELL AND THE LINER WERE LEFT IN-SITU. REVIEW OF RECEIVED DATA: NO MEDICAL DATA SUCH AS X-RAYS, SURGICAL NOTES OR ANY OTHER CASE-RELEVANT DOCUMENTS WERE RECEIVED. DEVICES ANALYSIS: VISUAL EXAMINATION: THE BIOLOX HEAD SHOWS MULTIPLE SCRATCHES SPREAD OVER THE COMPLETE ARTICULATION SURFACE. ADDITIONALLY, MANY SCRATCHES CAN BE FOUND ON THE CHAMFER. WITHIN THE TAPER CONNECTION CIRCULAR SCRATCHES CAN BE FOUND, ESPECIALLY AT THE HEIGHT WHERE THE TAPER CONNECTION MATES WITH THE STEM TAPER. TWO RECEIVED PICTURES SHOW THE HEAD ASSEMBLED WITH THE BROKEN STEM. MEASUREMENTS: NO MEASUREMENT WAS TAKEN AS THE REVISION TOOK PLACE DUE TO NECK FRACTURE OF THE STEM AND NOT DUE TO HEAD FAILURE OR FAILURE OF THE MATING CONDITION BETWEEN NECK AND HEAD. FUNCTIONAL TEST: NO FUNCTIONAL TEST WAS PERFORMED AS THE REVISION TOOK PLACE DUE TO NECK FRACTURE OF THE STEM AND NOT DUE TO HEAD FAILURE OR FAILURE OF THE MATING CONDITION BETWEEN NECK AND HEAD. REVIEW OF PRODUCT DOCUMENTATION: THE COMPATIBILITY CHECK WAS PERFORMED AND SHOWED THAT THE PRODUCT COMBINATION WAS APPROVED BY ZIMMER BIOMET. INSPECTION PLAN SAP DOC NO. 84706 REV. 04 (WITH DRAWING Z50_063.288.124 REV 02, APPLICABLE FOR SIZE 36): CHARACTERISTIC NO. 10 FEATURE DIMENSION (22.5 0.5/-0.5) WITH SCOPE OF TESTING: 100%. MEANS OF INSPECTION: 3D MEASURING MACHINE. CHARACTERISTIC NO. 11 FEATURE DIMENSION (16.5 0.5/-0.5) WITH SCOPE OF TESTING: FAL. MEANS OF INSPECTION: N/A. CHARACTERISTIC NO. 14 FEATURE CIRCULARITY (0.008) WITH SCOPE OF TESTING: 100%. MEANS OF INSPECTION: 3D MEASURING MACHINE. CHARACTERISTIC NO. 15 FEATURE LINE PROFILE (0.003) WITH SCOPE OF TESTING: 100%. MEANS OF INSPECTION: 3D MEASURING MACHINE. CHARACTERISTIC NO. 16 FEATURE RADIUS (2) WITH SCOPE OF TESTING: 100%. MEANS OF INSPECTION: VISUAL. ROOT CAUSE ANALYSIS: THE HEAD WAS REVISED TOGETHER WITH THE FRACTURED STEM NECK, NO ALLEGED DEFICIENCY OF THE BIOLOX HEAD WAS FOUND. HOWEVER, ALL POSSIBLE CAUSES RELATED TO THE BIOLOX HEAD SUBJECT TO THIS COMPLAINT ARE LISTED IN THE APPLICABLE RISK FILE. CONCLUSION SUMMARY: BASED ON THE RETURNED PRODUCT AND THE GIVEN INFORMATION THE COMPLAINT CONSISTING OF FEMORAL NECK FRACTURE COULD BE CONFIRMED. THE PATIENT WAS IMPLANTED WITH A RIGHT HIP TEP ON (B)(6) 2015. FOLLOWING, THE PATIENT UNDERWENT A REVISION SURGERY ON (B)(6) 2018 DUE TO NECK FRACTURE OF THE IMPLANTED STEM. DURING REVISION SURGERY THE STEM AND THE MOUNTED BIOLOX HEAD WERE REVISED, THE SHELL AND THE LINER WERE LEFT IN-SITU. THE VISUAL EXAMINATION OF THE BIOLOX HEAD SHOWED MULTIPLE SCRATCHES SPREAD OVER THE COMPLETE ARTICULATION SURFACE, ON THE CHAMFER, AS WELL AS ON THE TAPER CONNECTION. HOWEVER, IT REMAINS UNKNOWN WHICH SCRATCHES WERE INTRODUCED DURING REMOVAL OF THE HEAD DURING REVISION. FURTHER, NO INCONSPICUOUSNESS WERE IDENTIFIED. THE QUALITY RECORDS SHOW THAT ALL SPECIFIED CHARACTERISTICS (MATERIAL, DIMENSIONS, SURFACE, ETC.) HAVE MET THE SPECIFICATIONS VALID AT THE TIME OF PRODUCTION. THEREFORE, BASED ON THE GIVEN INFORMATION AND THE RESULTS OF THE INVESTIGATION, NO ALLEGED PRODUCT DEFICIENCY WAS IDENTIFIED WITH RESPECT TO THE RETURNED BIOLOX HEAD, WHICH WAS REVISED TOGETHER WITH THE FRACTURED STEM NECK. THIS IS A SPLIT CASE WITH ZIMMER INC., WARSAW, REFERENCE NUMBER : (B)(4) (MFR 0001822565-2018-01574 AND MFR 0001822565-2018-01575). 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.
ADDITIONAL CONCOMITANT MEDICAL PRODUCTS: MODULAR FEMORAL STEM PRESS-FIT PLASMA SPRAYED CEMENTLESS SIZE 10, (B)(4), LOT#62953059; MODULAR NECK CC 12/14 NECK TAPER USE WITH +0 HEADS ONLY, (B)(4), LOT# 62028976; NEUTRAL LINER 36 MM I.D. SIZE II FOR USE WITH 52 MM O.D. SIZE II SHELL, (B)(4), LOT# 62919895; SHELL WITH CLUSTER HOLES POROUS 52 MM O.D. SIZE II FOR USE WITH II LINERS, (B)(4), LOT# 62876394. THIS IS A SPLIT CASE WITH ZIMMER INC., (B)(4) (MFR NUMBERS NOT YET AVAILABLE). THE MANUFACTURER DID NOT RECEIVE THE DEVICE FOR INVESTIGATION BUT IT IS MENTIONED BY COMPLAINANT THAT IT WILL BE PROVIDED. NO SURGICAL REPORT OR X-RAYS WERE PROVIDED FOR REVIEW. WHERE LOT NUMBERS WERE RECEIVED FOR THE DEVICES, THE DEVICE HISTORY RECORDS WERE REVIEWED AND FOUND TO BE CONFORMING. A CAUSE FOR THIS SPECIFIC EVENT CANNOT BE ASCERTAINED FROM THE INFORMATION PROVIDED. ADDITIONAL INFORMATION HAS BEEN REQUESTED AND IS CURRENTLY NOT AVAILABLE. AS SOON AS ADDITIONAL INFORMATION BECOME AVAILABLE AND/OR AN INVESTIGATION RESULT BE AVAILABLE, AN AMENDED MEDICAL DEVICE REPORT WILL BE SUBMITTED. (B)(4).
ADDITIONAL INFORMATION HAS BEEN RECEIVED. AS SOON AS ADDITIONAL INFORMATION BECOME AVAILABLE AND/OR AN INVESTIGATION RESULT BE AVAILABLE, AN AMENDED MEDICAL DEVICE REPORT WILL BE SUBMITTED. ZIMMER'S REFERENCE NUMBER OF THIS FILE IS (B)(4).
IT WA REPORTED THAT THE PATIENT RECEIVED A THA AND UNDERWENT A REVISION SURGERY AROUND 3 YEARS POST-IMPLANTATION DUE TO IMPLANT BREAKAGE. HEAD, NECK AND STEM WERE EXPLANTED.
IT WAS NOW ADDITIONALLY REPORTED THAT THE MODULAR NECK WAS BROKEN AND NOT THE HEAD. DURING REVISION, HEAD WAS EXCHANGED ALONG WITH NECK.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 188678 | BIOLOX DELTA, CERAMIC FEMORAL HEAD, M, 36/0, TAPER 12/14 | BIOLOX DELTA CERAMIC FEMORAL HEAD | LZO | ZIMMER GMBH | N/A | 2720484 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 51 YR | Hospitalization| R |