BONE SCREW Ø6,5 H.20MM
Report
- Report Number
- 3008021110-2023-00106
- Event Type
- Injury
- Date Received
- September 4, 2023
- Date of Event
- August 28, 2023
- Report Date
- November 14, 2023
- Manufacturer
- LIMACORPORATE S.P.A.
- Product Code
- PHX
- PMA / PMN Number
- K172456
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Occupation
- OTHER
- Health Professional
- N
Narratives
CHECKING THE MANUFACTURING CHARTS OF THE INVOLVED LOT#: 2115276, NO PRE-EXISTING ANOMALY WAS FOUND ON (B)(4) ITEMS MANUFACTURED WITH THE SAME LOT#. ACCORDING TO OUR RECORDS, AT LEAST (B)(4) OUT OF (B)(4) BONE SCREWS WITH LOT#: 2115276 AND STER. 2100253 HAVE BEEN IMPLANTED AND THIS IS THE ONLY COMPLAINT RECEIVED ON THIS LOT#. DEVICE ANALYSIS: THE ITEM INVOLVED WAS NOT AVAILABLE TO BE RETURNED TO LIMACORPORATE FOR FURTHER ANALYSIS. X-RAYS ANALYSIS: LIMACORPORATE RECEIVED A TOTAL OF THREE X-RAYS REFERRING TO PRE-OPERATIVE OF THE FIRST REVISION SURGERY (EXACT DATE NOT KNOWN) AND ONE X-RAY REFERRING TO PRE-OPERATIVE OF THE SECOND REVISION SURGERY (TAKEN ON (B)(6) 2023). THE X-RAYS RECEIVED AND A PICTURE OF EXPLANTED DEVICES HAVE BEEN EVALUATED BY A MEDICAL CONSULTANT. FOLLOWING, THE MEDICAL CONSULTANT COMMENTS: "THE RADIOGRAPHS MAKE AN IRRITATION OF THE SUPRASCAPULAR NERVE POSSIBLE, AS THEY APPEAR TO PROTRUDE A LITTLE AND THE GLENOID IS SMALL. BUT THIS IS HARD TO PROVE. PAIN AFTER RSA CAN HAVE MULTIPLE REASONS, BICEPS, SOFT TISSUES, DELTA, TENSION[?] THE RADIOGRAPHS ARE NOT INDICATIVE OF ANY SPECIFIC PROBLEM. RETRIEVALS LOOK UNREMARKABLE. THERE IS NO IMPLANT-RELATED PROBLEM". CONSIDERING THAT: · CHECK OF MANUFACTURING CHARTS HIGHLIGHTED NO ANOMALIES ON THE COMPONENTS MANUFACTURED WITH LOT#: 2115276; · ACCORDING TO THE RECEIVED INFORMATION, THE SUPERIOR BONE SCREW WAS PROTRUDING OUT OF THE SCAPULA, CAUSING DISCOMFORT AND PAIN; · ACCORDING TO THE MEDICAL CONSULTANT "PAIN AFTER RSA CAN HAVE MULTIPLE REASONS, BICEPS, SOFT TISSUES, DELTA, TENSION... THE RADIOGRAPHS ARE NOT INDICATIVE OF ANY SPECIFIC PROBLEM. RETRIEVALS LOOK UNREMARKABLE. THERE IS NO IMPLANT-RELATED PROBLEM"; WE CANNOT DRAW A DEFINITIVE ROOT CAUSE FOR THE EVENT, STILL 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 PAIN 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.
CHECKING THE MANUFACTURING CHARTS OF THE INVOLVED LOT #2115276, NO PRE-EXISTING ANOMALIES WERE FOUND ON THE 200 COMPONENTS MANUFACTURED WITH THAT LOT #. THIS IS THE FIRST AND ONLY COMPLAINT RECEIVED ON THE LOT #. WE SUBMIT A FINAL MDR AS SOON AS THE INVESTIGATION IS COMPLETE.
SHOULDER REVISION SURGERY OF A SMR REVERSE IMPLANT PERFORMED ON (B)(6) 2023, DUE TO PAIN AND IRRITATION OF SUPRASCAPULAR NERVE. IT WAS REPORTED THAT THE SUPERIOR BONE SCREW Ø6,5 H.20MM (PRODUCT CODE: 8420.15.010, LOT#: 2115276 - STER. 2100253) WAS PROTRUDING OUT OF THE SCAPULA, CAUSING DISCOMFORT AND PAIN. THE FOLLOWING COMPONENTS WERE REMOVED TO GAIN ACCESS TO THE GLENOID: SMR REVERSE HP LATERALIZED LINER MEDIUM (PRODUCT CODE: 1362.09.115, LOT#: 2222528 - STER. 2200295) - PRODUCT NOT SOLD IN THE US; SMR CONNECTOR SMALL STD (PRODUCT CODE: 1374.15.310, LOT#: 2213073 - STER. 2200172); SMR REVERSE HP CORRECTIVE GLENOSPHERE (PRODUCT CODE: 1374.50.444, LOT#: 2213670 - STER. 2200170) - PRODUCT NOT SOLD IN THE US. THE SUPERIOR BONE SCREW Ø6,5 H.20MM (PRODUCT CODE: 8420.15.010, LOT#:2115276 - STER. 2100253) WAS EXPLANTED. NEW 40MM GLENOSPHERE AND 40MM MEDIUM LATERALIZED LINER WERE IMPACTED. PATIENT IS A FEMALE, 67 YEARS OLD. SHE HAS A BMI OF 25. HER HISTORY OF SHOULDER SURGERIES IS THE FOLLOWING: · PRIMARY SURGERY TOOK PLACE ON (B)(6) 2022; · FIRST REVISION SURGERY PERFORMED ON (B)(6) 2022, DUE TO ONGOING PAIN SINCE AFTER PRIMARY SURGERY THAT DIDN'T SUBSIDE. THE EVENT WAS REGISTERED AS COMPLAINT#: (B)(4); · SECOND REVISION SURGERY PERFORMED ON (B)(6) 2023, DUE TO PAIN AND IRRITATION OF SUPRASCAPULAR NERVE (HEREBY REPORTED). EVENT HAPPENED IN AUSTRALIA.
SHOULDER REVISION SURGERY OF A SMR REVERSE IMPLANT PERFORMED ON (B)(6) 2023, DUE TO PAIN AND IRRITATION OF SUPRASCAPULAR NERVE. IT WAS REPORTED THAT THE SUPERIOR BONE SCREW Ø6,5 H.20MM (PRODUCT CODE 8420.15.010, LOT #2115276 - STER. 2100253) WAS PROTRUDING OUT OF THE SCAPULA, CAUSING DISCOMFORT AND PAIN. THE FOLLOWING COMPONENTS WERE REMOVED TO GAIN ACCESS TO THE GLENOID: · SMR REVERSE HP LATERALIZED LINER MEDIUM (PRODUCT CODE 1362.09.115, LOT #2222528 - STER. 2200295) - PRODUCT NOT SOLD IN THE US; · SMR CONNECTOR SMALL STD (PRODUCT CODE 1374.15.310, LOT #2213073 - STER. 2200172); · SMR REVERSE HP CORRECTIVE GLENOSPHERE (PRODUCT CODE 1374.50.444, LOT # 2213670 - STER. 2200170) - PRODUCT NOT SOLD IN THE US. THE SUPERIOR BONE SCREW Ø6,5 H.20MM (PRODUCT CODE 8420.15.010, LOT #2115276 - STER. 2100253) WAS EXPLANTED. NEW 40MM GLENOSPHERE AND 40MM MEDIUM LATERALIZED LINER WERE IMPACTED. PATIENT IS A FEMALE, 67 YEARS OLD. SHE HAS A BMI OF 25. HER HISTORY OF SHOULDER SURGERIES IS THE FOLLOWING: · PRIMARY SURGERY TOOK PLACE ON (B)(6) 2022; · FIRST REVISION SURGERY PERFORMED ON (B)(6) 2022, DUE TO ONGOING PAIN SINCE AFTER PRIMARY SURGERY THAT DIDN'T SUBSIDE. THE EVENT WAS REGISTERED AS COMPLAINT #(B)(4). · SECOND REVISION SURGERY PERFORMED ON (B)(6) 2023, DUE TO PAIN AND IRRITATION OF SUPRASCAPULAR NERVE (HEREBY REPORTED). EVENT HAPPENED IN AUSTRALIA.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1679074 | BONE SCREW Ø6,5 H.20MM | BONE SCREWS DIA. 6.5 X H. 20 MM | PHX | LIMACORPORATE S.P.A. | 8420.15.010 | 2115276 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Unknown | Required Intervention |