DUAL MOBILITY - UHMWPE
Report
- Report Number
- 3008021110-2020-00004
- Event Type
- Injury
- Date Received
- January 29, 2020
- Date of Event
- November 28, 2019
- Report Date
- January 29, 2020
- Manufacturer
- LIMACORPORATE SPA
- Product Code
- LZO
- PMA / PMN Number
- K181491
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Occupation
- OTHER
Narratives
BY CHECKING THE STERILIZATION CHARTS OF THE LIMA COMPONENTS INVOLVED, NO PRE-EXISTING ANOMALY WAS DETECTED ON THE 91 DELTA LINERS BELONGING TO LOT# 1880166 STER.1800073 AND ON THE 87 MOBILE LINERS BELONGING TO LOT#18AT1HJ STER.1800243 THEREFORE, WE CAN STATE ALL THE COMPONENTS HAVE BEEN REGULARLY STERILIZED BEFORE BEING PLACED ON THE MARKET. PRE-REVISION SURGERY X- RAYS (EXACT DATE UNKNOWN) WERE PROVIDED AND ANALYZED BY OUR MEDICAL CONSULTANT, TOGETHER WITH SOME PICTURES OF THE EXPLANTED COMPONENTS. HIS COMMENTS AS PER FOLLOWS: "WHEN THE PRIMARY SURGERY TOOK PLACE (B)(6) 2018 AND REVISION DUE TO INFECTION (B)(6) 2019 (<2YRS AFTER IMPLANTATION) IT MUST BE CLASSIFIED AS A SO CALLED DELAYED OR CHRONIC INFECTION ACCORDING TO INTERNATIONAL CLASSIFICATION (HTTPS://WWW.NCBI.NLM.NIH.GOV/PMC/ARTICLES/PMC6667982/) THE CORRECT PROCEDURE IN SUCH CASE WOULD BE COMPLETE REMOVAL OF ALL COMPONENTS AND REIMPLANTATION IN ONE OR MORE STAGES. THE SURGEON CHOSE ONLY TO EXCHANGE THE MOBILE PARTS, A PROCEDURE THAT IS KNOWN AS DAIR, WHICH SHOULD ONLY BE USED IN ACUTE INFECTIONS (<4WEEKS AFTER SURGERY). IT SUCH IS NOT ACCORDING TO STANDARDS AND REINFECTION AFTER SOME TIME MUST BE EXPECTED. BESIDE THAT I FIND NO FAILURE, NEITHER ON THE X-RAYS NOR ON THE EXPLANTS. AS LONG AS STERILITY OF THE IMPLANTS CAN BE PROVEN FROM THE RESPECTIVE BATCH DOCUMENTATION I DO NOT SEE ANY REASON FOR BLAMING THE IMPLANTS FOR THE REPORTED FAILURE." IN CONCLUSION, WE CANNOT GO BACK WITH CERTAINTY TO THE ROOT CAUSE OF THE INFECTION REPORTED, HOWEVER, ACCORDING TO OUR ANALYSIS, THIS EVENT CANNOT BE CLASSIFIED AS PRODUCT-RELATED. PMS DATA BASED ON OUR PMS DATA, WE CAN ESTIMATE A REVISION RATE OF UHMWPE MOBILE LINERS (5566.50.XXX-5565.50.XXX) DUE TO INFECTION OF 0.059%. NO SPECIFIC ACTION FOR THIS CASE. LIMA CORPORATE WILL CONTINUE MONITORING THE MARKET TO PROMPTLY DETECT ANY FURTHER SIMILAR EVENT.
REVISION SURGERY DUE TO HIP INFECTION PERFORMED ON (B)(6) 2019. PREVIOUS SURGERY WAS PERFORMED ON (B)(6) 2018. DURING PREVIOUS SURGERY, STEM AND FEMORAL HEAD FROM A DIFFERENT MANUFACTURER WERE IMPLANTED. DURING REVISION SURGERY, ONLY THE FOLLOWING COMPONENTS WERE EXPLANTED AND REPLACED: DELTA LINER ØINT 40MM # LARGE 5885.42.262 LOT#1880166 STER.1800073 (MODEL NOT MARKETED IN THE USA). MOBILE LINER ØINT 28 MM Ø40 MM 5566.50.401 LOT#18AT1HJ STER.1800243. FEMORAL HEAD (NOT MANUFACTURED BY LIMA). THE ACETABULAR CUP AND THE STEM WERE LEFT IN SITU. PATIENT DATA: FEMALE. NO OTHER INFORMATION AVAILABLE. EVENT HAPPENED IN AUSTRALIA.
BY CHECKING THE STERILIZATION CHARTS OF THE LOT/STER#S INVOLVED, NO PRE-EXISTING ANOMALY WAS DETECTED. THEREFORE, WE CAN STATE ALL THE COMPONENTS HAVE BEEN PROPERLY STERILIZED BEFORE BEING PLACED ON THE MARKET. WE WILL PERFORM A FINAL MDR ONCE THE INVESTIGATION WILL BE CONCLUDED.
REVISION SURGERY DUE TO INFECTION PERFORMED ON THE (B)(6) 2019. PREVIOUS SURGERY WAS PERFORMED ON THE (B)(6) 2018. DURING REVISION, ONLY THE FOLLOWING COMPONENTS WERE EXPLANTED: DUAL MOBILITY - UHMWPE 5566.50.401 LOT#18AT1HJ STER.1800243. DELTA LINER (NOT MARKED IN USA). FEMORAL HEAD BY ANOTHER MANUFACTURER. THE CUP AND THE STEM WERE LEFT IN SITU. NO OTHER INFORMATION AVAILABLE. EVENT HAPPENED IN (B)(6).
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 104750 | DUAL MOBILITY - UHMWPE | DUAL MOBILITY - UHMWPE (LZO, LPH, MBL) | LZO | LIMACORPORATE SPA | 5566.50.401 | 18AT1HJ |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Required Intervention |