MAUDE Adverse Event Report: LIMACORPORATE S.P.A. SMR CEMENTLESS FINNED STEM; FINNED HUMERAL STEMS - 80MM (TI6AL4V) DIA.16MM

Model Number 1304.15.160

Device Problem Loosening of Implant Not Related to Bone-Ingrowth (4002)

Patient Problem Inadequate Osseointegration (2646)

Event Date 10/30/2023

Event Type  Injury  

Manufacturer Narrative

Checking the manufacturing charts of involved lot #2012511, 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 of a smr reverse implant performed on (b)(6) 2023, due to implant loosening.The humeral component was loose.The glenoid side was removed as well: smr cementless finned stem (product code 1304.15.160, lot #2012511 - ster.2000361).Smr reverse humeral body (product code 1352.20.010, lot #2020854 - ster.2100029) - product not sold in the us.Smr reverse hp liner short (product code 1365.09.010, lot #1903717 - ster.1900158) - product not sold in the us.Smr connector small r (product code 1374.15.305, lot #2017363 - ster.2000315).Smr reverse hp glenosphere 40 mm (product code 1374.50.400, lot #2020679 - ster.2000345) - product not sold in the us.Smr uncemented glenoid #small-r (product code 1375.20.005, lot #2012380 - ster.2000253) - product not sold in the us.Bone screw ø6,5 h.25mm (product code 8420.15.020, lot #2006394 - ster.2000204).Bone screw ø6,5 h.25mm (product code 8420.15.020, lot #2018914 - ster.2000355).It was reported that the patient never felt comfortable or happy after primary surgery, which took place on (b)(6) 2021.Patient is a female, 82 years old.No comorbidities reported.Event happened in australia.

Manufacturer Narrative

Checking the manufacturing charts of the involved lot #2012511, no pre-existing anomaly was found on the 35 devices manufactured with that lot #.According to our records, at least 33 out of 35 humeral stems with lot #2012511 and ster.2000361 have been implanted and this is the only complaint received on this lot #.Device analysis: items involved were 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 revision surgery.The x-rays received - dated (b)(6) 2023 - and three pictures of the explanted devices have been evaluated by a medical consultant.Following, the medical consultant comments: "the humeral component looks slightly undersized on the ap-radiographs, the fins do not engage the cortex.There is no bone on the explant, which reinforces the theory that this could have been a problem.The glenoid component is loose and broken out.There maybe a surgical error component in this, but this is a bit speculative.I cannot see any implant-related issue here".Based on the available information, no further investigation could have been performed.Considering that: check of manufacturing charts highlighted no anomalies on components manufactured with lot #2012511; · according to the medical consultant "the humeral component looks slightly undersized on the ap-radiographs, the fins do not engage the cortex" and "there maybe a surgical error component in this, but this is a bit speculative.I cannot see any implant-related issue here"; we are not able to draw a definitive root-cause for the event, still we can state that it wasn't product related.Pms data: according to limacorporate pms data, the revision rate of smr reverse prosthesis due to loosening of the humeral side 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.

Event Description

Shoulder revision surgery of a smr reverse implant performed on (b)(6) 2023, due to implant loosening.The humeral component was loose, the glenoid side was removed as well: smr cementless finned stem (product code 1304.15.160, lot #2012511 - ster.2000361).Smr reverse humeral body (product code 1352.20.010, lot #2020854 - ster.2100029) - product not sold in the us.· smr reverse hp liner short (product code 1365.09.010, lot #1903717 - ster.1900158) - product not sold in the us.· smr connector small r (product code 1374.15.305, lot #2017363 - ster.2000315).· smr reverse hp glenosphere 40 mm (product code 1374.50.400, lot #2020679 - ster.2000345) - product not sold in the us.· smr uncemented glenoid #small-r (product code 1375.20.005, lot #2012380 - ster.2000253) - product not sold in the us.· bone screw ø6,5 h.25mm (product code 8420.15.020, lot #2006394 - ster.2000204).· bone screw ø6,5 h.25mm (product code 8420.15.020, lot #2018914 - ster.2000355).It was reported that the patient never felt comfortable or happy after primary surgery, which took place on (b)(6) 2021.Patient is a female, 82 years old.No comorbidities reported.No further clinical information available.Event happened in australia.

• Brand Name: SMR CEMENTLESS FINNED STEM
• Type of Device: FINNED HUMERAL STEMS - 80MM (TI6AL4V) DIA.16MM
• Manufacturer (Section D): LIMACORPORATE S.P.A.; via nazionale 52; villanova di san daniele, udine 33038 ; IT 33038
• MDR Report Key: 18131378
• MDR Text Key: 328052938
• Report Number: 3008021110-2023-00129
• Device Sequence Number: 1
• Product Code: HSD
• Combination Product (y/n): N
• PMA/PMN Number: K101263
• 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: 02/15/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Model Number: 1304.15.160
• Device Lot Number: 2012511
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 11/14/2023
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 02/20/2024
• 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): Required Intervention