SMR TRAUMA HUM. BODY # SHORT
Report
- Report Number
- 3008021110-2023-00028
- Event Type
- Injury
- Date Received
- March 23, 2023
- Date of Event
- March 2, 2023
- Report Date
- June 9, 2023
- Manufacturer
- LIMACORPORATE S.P.A
- Product Code
- KWT
- PMA / PMN Number
- K100858
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Occupation
- OTHER
- Health Professional
- N
Narratives
CHECKING MANUFACTURING RECORDS FOR LOT #2206485 AND LOT #2124629 NO PRE-EXISTING ANOMALIES FOUND ON THE COMPONENTS MANUFACTURED WITH THESE LOT #'S. NO OTHER COMPLAINTS WERE REPORTED ON THE SAME LOT NUMBERS. X-RAY ANALYSIS. NO ADDITIONAL DETAILS WERE AVAILABLE ON THIS POST-OPERATIVE ISSUE, SPECIFICALLY PRE-OPERATIVE OR POST-OPERATIVE X-RAYS RELATED TO THE REVISION SURGERY WERE REQUESTED TO THE COMPLAINT SOURCE, HOWEVER THEY WERE NOT AVAILABLE. BASED ON THE FEW INFORMATION RECEIVED, WE ARE NOT ABLE TO FURTHER INVESTIGATE THE ROOT CAUSE OF THE EVENT. CONSIDERING THAT: CHECK OF THE MANUFACTURING RECORDS HIGHLIGHTED NO ANOMALIES ON COMPONENTS MANUFACTURED WITH THE INVOLVED LOT #S. IT WAS ALSO REPORTED THAT A LARGE PATIENT WAS INVOLVED AND HAD A FRACTURE PRIOR TO INITIAL SURGERY. WE CAN STATE THAT THE EVENT WAS NOT PRODUCT RELATED. PMS DATA: (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 FINAL MDR.
CHECKING MANUFACTURING RECORDS FOR LOT #2206485 AND LOT #2124629 NO PRE-EXISTING ANOMALIES FOUND ON THE COMPONENTS MANUFACTURED WITH THESE LOT #'S. NO OTHER COMPLAINTS REPORTED ON THE SAME LOT NUMBERS. WILL SUBMIT FINAL REPORT ONCE THE INVESTIGATION IS COMPLETE.
SHOULDER REVISION SURGERY WAS PERFORMED ON (B)(6) 2023, FOR A NEUTRAL ADAPTER THAT DISASSOCIATED FROM TRAUMA BODY WHILE PATIENT WAS MOVING IN REHAB. DURING REVISION THE SURGEON NOTICED THAT THE FRACTURE WAS STILL A FACTOR AND THAT MORE WOULD HAVE BEEN NEEDED TO BE DONE IN ORDER TO ACCOUNT FOR THE ISSUE. AGENT REPORTED: DUE TO THE FRACTURE THE HUMERAL BODY WAS PLACED TO THE BEST OF THE SURGEON'S ABILITY. THE FRACTURE WAS MOST LIKELY THE ISSUE. IT WAS ALSO REPORTED A LARGE PATIENT WAS INVOLVED AND WAS A FRACTURE PRIOR TO INITIAL SURGERY. COMPONENTS EXPLANTED. NEUTRAL ADAPTOR TAPER STANDARD - COMMERCIAL CODE # 1330.15.270 LOT #2206485 -STER. #2200119. SMR TRAUMA HUM. BODY # SHORT - COMMERCIAL CODE #1350.15.030 - LOT #2124629 - STER. #2200010. INITIAL SURGERY - (B)(6) 2023. PATIENT - MALE. AGE - 68. APPROX. HEIGHT - 1.68M. WEIGHT - 181KG. THIS EVENT OCCURRED IN U.S..
SHOULDER REVISION SURGERY WAS PERFORMED ON (B)(6) 2023, FOR A NEUTRAL ADAPTER THAT DISASSOCIATED FROM TRAUMA BODY WHILE PATIENT WAS MOVING IN REHAB. DURING REVISION THE SURGEON NOTICED THAT THE FRACTURE WAS STILL A FACTOR AND THAT MORE WOULD HAVE BEEN NEEDED TO BE DONE IN ORDER TO ACCOUNT FOR THE ISSUE. AGENT REPORTED: DUE TO THE FRACTURE THE HUMERAL BODY WAS PLACED TO THE BEST OF THE SURGEON'S ABILITY. THE FRACTURE WAS MOST LIKELY THE ISSUE. LARGE PATIENT AND WAS A FRACTURE PRIOR TO INITIAL SURGERY. COMPONENTS EXPLANTED. NEUTRAL ADAPTOR TAPER STANDARD - COMMERCIAL CODE # 1330.15.270 LOT #2206485 -STER. #2200119. SMR TRAUMA HUM. BODY # SHORT - COMMERCIAL CODE #1350.15.030 - LOT #2124629 - STER. #2200010. INITIAL SURGERY - (B)(6) 2023. PATIENT - MALE. AGE - 68. APPROX. HEIGHT - 1.68M. WEIGHT - 181KG. THIS EVENT OCCURRED IN U.S.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 370570 | SMR TRAUMA HUM. BODY # SHORT | SMR TRAUMA HUM. BODY # SHORT | KWT | LIMACORPORATE S.P.A | 1350.15.030 | 2124629 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 68 YR | Male | Required Intervention |