BONE SCREW Ø6,5 H.20MM
Report
- Report Number
- 3008021110-2021-00088
- Event Type
- Injury
- Date Received
- November 17, 2021
- Date of Event
- November 8, 2021
- Report Date
- February 28, 2022
- Manufacturer
- LIMACORPORATE S.P.A.
- Product Code
- LPH
- PMA / PMN Number
- K172456
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Occupation
- OTHER
- Health Professional
- N
Narratives
BY CHECKING THE STERILIZATION CHARTS OF THE INVOLVED LOT #S, NO PRE-EXISTING ANOMALY WAS FOUND ON THE OVERALL NUMBER. ALL THE PRODUCTS WITH THESE LOT #S HAVE BEEN PROPERLY STERILIZED BEFORE BEING PLACED ON THE MARKET. EXPLANTS ANALYSIS: ITEMS INVOLVED WERE NOT AVAILABLE TO BE RETURNED TO LIMACORPORATE FOR FURTHER ANALYSIS. X-RAYS ANALYSIS: LIMACORPORATE RECEIVED ONE X-RAY REFERRING TO PRE-OPERATIVE REVISION SURGERY. THE X-RAY RECEIVED - DATED (B)(6) 2021 - HAS BEEN EVALUATED BY A MEDICAL CONSULTANT. FOLLOWING, THE MEDICAL CONSULTANT COMMENTS: "AS FAR AS I CAN SEE THERE WAS A POSTOP INFECTION AND PARTIAL IMPLANT REMOVAL BEFORE THE INDEX OPERATION HERE. I DO NOT SEE ANY IMPLANT-RELATED PROBLEMS HERE". CONSIDERING THAT: · CHECK OF THE STERILIZATION CHARTS HIGHLIGHTED NO ANOMALIES ON THE COMPONENTS STERILIZED WITH THE INVOLVED LOT #S; · ACCORDING TO THE MEDICAL CONSULTANT, THERE WAS A POST-OP INFECTION AND NO IMPLANT-RELATED PROBLEMS; WE CAN STATE THAT THE EVENT WAS NOT PRODUCT RELATED. PMS DATA: ACCORDING TO LIMACORPORATE PMS DATA, REVISION RATE OF SMR REVERSE PROSTHESIS DUE TO INFECTION IS (B)(4). BASED ON THE ROOT CAUSE ANALYSIS PERFORMED AND ACCORDING TO THE RELEVANT PMS DATA, NO CORRECTIVE ACTIONS REQUIRED FOR THIS SPECIFIC CASE. LIMACORPORATE WILL CONTINUE MONITORING THE MARKET TO PROMPTLY DETECT ANY FURTHER SIMILAR ISSUE. NOTE: THIS IS A FINAL MDR.
BY CHECKING THE DHR OF THE INVOLVED LOT #1901275, LOT #1902795 AND LOT #1903156 NO PRE-EXISTING ANOMALY WAS FOUND ON THE ITEMS PLACED ON THE MARKET WITH THE SAME LOT #S. THIS IS THE FIRST AND ONLY COMPLAINT RECEIVED ON THESE LOT #S. WE WILL SUBMIT A FINAL MDR AS SOON AS THE INVESTIGATION WILL BE COMPLETED.
SHOULDER REVISION SURGERY OF A SMR REVERSE IMPLANT PERFORMED ON (B)(6), 2021, DUE TO INFECTION, RESULTING IN IMPLANT LOOSENING. IT WAS REPORTED THAT THE FOLLOWING COMPONENTS WERE REMOVED: · SMR UNCEMENTED GLENOID #SMALL-R (PRODUCT CODE 1375.20.005, LOT #1901275 - STER. 1900092) - PRODUCT NOT SOLD IN THE US. · BONE SCREW Ø6,5 H.20MM (PRODUCT CODE 8420.15.010, LOT #1902795 - STER. 1900086). · BONE SCREW Ø6,5 H.30MM (PRODUCT CODE 8420.15.030, LOT #1903156 - STER. 1900099). A COMPETITOR'S PROSTHESIS WAS IMPLANTED. ACCORDING TO THE COMPLAINT SOURCE, SWABS WERE TAKEN, HOWEVER THE RESULTS ARE NOT AVAILABLE. BASED ON THE PROVIDED INFORMATION, PATIENT' HISTORY IS THE FOLLOWING: - PRIMARY SURGERY PERFORMED ON (B)(6), 2019. SMR REVERSE PROSTHESIS IMPLANTED; - FIRST REVISION SURGERY TOOK PLACE ON (B)(6), 2019, DUE TO DISLOCATION. THE COMPLAINT WAS REGISTERED AS LIMACORPORATE #(B)(4). PATIENT WAS NON COMPLAINT TO POST SURGERY RECOMMENDATIONS; - SECOND REVISION SURGERY PERFORMED ON (B)(6), 2020, DUE TO INSTABILITY AND INFECTION. NO FURTHER DETAILS AVAILABLE. PATIENT IS A FEMALE, 61 YEARS OLD. ACCORDING TO THE REPORTED INFORMATION, PATIENT HAS A MODERATE BMI, AND PERFORMS LOW PHYSICAL ACTIVITY LEVEL. EVENT HAPPENED IN AUSTRALIA.
SHOULDER REVISION SURGERY OF A SMR REVERSE IMPLANT PERFORMED ON (B)(6) 2021, DUE TO INFECTION RESULTING IN IMPLANT LOOSENING. IT WAS REPORTED THAT THE FOLLOWING COMPONENTS WERE REMOVED: SMR UNCEMENTED GLENOID #SMALL-R (PRODUCT CODE 1375.20.005, LOT #1901275 - STER. 1900092) - PRODUCT NOT SOLD IN THE US. BONE SCREW Ø6,5 H.20MM (PRODUCT CODE 8420.15.010, LOT #1902795 - STER. 1900086). BONE SCREW Ø6,5 H.30MM (PRODUCT CODE 8420.15.030, LOT #1903156 - STER. 1900099). A COMPETITOR'S PROSTHESIS WAS IMPLANTED. ACCORDING TO THE COMPLAINT SOURCE, SWABS WERE TAKEN, HOWEVER THE RESULTS ARE NOT KNOWN YET. BASED ON THE PROVIDED INFORMATION, PATIENT' HISTORY IS THE FOLLOWING: PRIMARY SURGERY PERFORMED ON (B)(6) 2019. SMR REVERSE PROSTHESIS IMPLANTED; FIRST REVISION SURGERY TOOK PLACE ON (B)(6) 2019, DUE TO DISLOCATION. THE COMPLAINT WAS REGISTERED AS LIMACORPORATE #(B)(4). PATIENT WAS NON COMPLAINT TO POST SURGERY RECOMMENDATIONS; SECOND REVISION SURGERY PERFORMED ON (B)(6) 2020, DUE TO INSTABILITY AND INFECTION. NO FURTHER DETAILS AVAILABLE. PATIENT IS A FEMALE, (B)(6). ACCORDING TO THE REPORTED INFORMATION, PATIENT HAS A MODERATE BMI, AND LOW PHYSICAL ACTIVITY LEVEL. EVENT HAPPENED IN (B)(6).
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1730706 | BONE SCREW Ø6,5 H.20MM | BONE SCREWS DIA. 6.5 X H. 20 MM | LPH | LIMACORPORATE S.P.A. | 8420.15.010 | 1902795 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Unknown | Required Intervention |