MAUDE Adverse Event Report: LIMACORPORATE S.P.A. SMR CEMENTED STEM Ø18 MM; CEMENTED HUMERAL STEMS L.80MM DIA.18MM

Model Number 1306.15.180

Device Problem Patient Device Interaction Problem (4001)

Patient Problem Inadequate Osseointegration (2646)

Event Date 10/26/2023

Event Type  Injury  

Event Description

Shoulder revision surgery performed on (b)(6) 2023, due to loosening of the smr cemented stem ø18 mm (product code 1306.15.180, lot #1517764 - ster.1600020).According to the received information, the glenosphere was not positioned correctly.All previous implants from the humerus and glenoid were explanted: · smr cemented stem ø18 mm (product code 1306.15.180, lot #1517764 - ster.1600020) · smr reverse finned humeral body (product code 1352.15.050, lot #2014056 - ster.2000306).· smr reverse hp lateralizing liner medium (product code 1362.09.115, lot #2017356 - ster.2000344) - product not sold in the us.· smr connector small r (product code 1374.15.305, lot #2016690 - ster.2000301) · reverse hp glenosphere 44 mm (product code 1374.50.440, lot #2021796 - ster.2000384) - product not sold in the us.· uncemented glenoid #small-r (product code 1375.20.005, lot #2000667 - ster.2000046) - product not sold in the us.· bone screw ø6,5 h.20mm (product code 8420.15.010, lot #1819377 - ster.1900018).· bone screw ø6,5 h.20mm (product code 8420.15.010, lot #1923169 - ster.2000037).It was reported that the cemented stem came out with all cement attached.A spacer was implanted.Explants were sent for testing of pathogens.Primary surgery was performed on (b)(6) 2020.The patient was revised on (b)(6) 2021, due to infection (the event was registered as complaint # (b)(4) and reported to the fda by mfr 3008021110-2023-00122).Patient is a female, 69 years old.Event happened in australia.

Manufacturer Narrative

Checking the manufacturing charts of involved lot #1517764, no pre-existing anomalies were found on the components manufactured with that lot #.This is the first and only complaint reported on the involved lot #.We submit a final mdr as soon as the investigation is complete.

Event Description

Shoulder revision surgery performed on (b)(6) 2023, due to loosening of the smr cemented stem ø18 mm (product code 1306.15.180, lot #1517764 - ster.1600020).According to the received information, the glenosphere was not positioned correctly.All previous implants from the humerus and glenoid were explanted: smr cemented stem ø18 mm (product code 1306.15.180, lot #1517764 - ster.1600020).Smr reverse finned humeral body (product code 1352.15.050, lot #2014056 - ster.2000306).Smr reverse hp lateralizing liner medium (product code 1362.09.115, lot #2017356 - ster.2000344) - product not sold in the us.Smr connector small r (product code 1374.15.305, lot #2016690 - ster.2000301).Reverse hp glenosphere 44 mm (product code 1374.50.440, lot #2021796 - ster.2000384) - product not sold in the us.Uncemented glenoid #small-r (product code 1375.20.005, lot #2000667 - ster.2000046) - product not sold in the us.Bone screw ø6,5 h.20mm (product code 8420.15.010, lot #1819377 - ster.1900018).Bone screw ø6,5 h.20mm (product code 8420.15.010, lot #1923169 - ster.2000037).It was reported that the cemented stem came out with all cement attached.A spacer was implanted.Explants were sent for testing of pathogens, however results were not accessible.The patient is going to be revised in february 2024 with a customized implant.Primary surgery was performed on (b)(6) 2020.The patient was revised on (b)(6) 2021, due to infection (the event was registered as complaint # (b)(4) and reported to the fda by mfr 3008021110-2023-00122).Patient is a female, 69 years old.No comorbidities reported.Event happened in australia.

Manufacturer Narrative

Checking the manufacturing charts of the involved lot #1517764, no pre-existing anomaly was found on the 63 devices manufactured with the same lot #.This is the first and only complaint registered on this lot #.Device analysis: items involved were not available to limacorporate for further analysis.No additional details were available on this post-operative issue, specifically the following information was requested to the complaint source, but it was not available: pre-operative x-rays related to the revision surgery; swabs results.Based on the very few information received, we are not able to further investigate the root cause of the event.However, considering that: check of the manufacturing charts highlighted no anomalies on components manufactured with lot #1517764; it was reported that the cemented stem came out with all cement attached; according to the received information, the glenosphere was not positioned correctly; we can state that the event was not product related.Pms data: according to limacorporate pms data, the revision rate of smr cemented stems - belonging to the family codes 1306.15.Xxx - due to loosening is 0.02%.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.

• Brand Name: SMR CEMENTED STEM Ø18 MM
• Type of Device: CEMENTED HUMERAL STEMS L.80MM DIA.18MM
• Manufacturer (Section D): LIMACORPORATE S.P.A.; via nazionale 52; villanova di san daniele, udine 33038 ; IT 33038
• MDR Report Key: 18085000
• MDR Text Key: 327541334
• Report Number: 3008021110-2023-00123
• Device Sequence Number: 1
• Product Code: KWT
• Combination Product (y/n): N
• PMA/PMN Number: K100858
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 02/01/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/07/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Model Number: 1306.15.180
• Device Lot Number: 1517764
• Is the Reporter a Health Professional?: No
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other