MAUDE Adverse Event Report: LIMACORPORATE S.P.A. SMR CEMENTLESS MINI STEM; FINNED HUMERAL STEMS - 60MM (TI6AL4V) DIA.11MM

Model Number 1304.15.110

Device Problem Loose or Intermittent Connection (1371)

Patient Problem Failure of Implant (1924)

Event Date 05/07/2021

Event Type  Injury  

Manufacturer Narrative

By checking the dhr of the lot #1920684, no pre-existing anomalies were detected on the pieces manufactured with this lot #.This is the first and only complaint received on this lot#.We will submit a final mdr once the investigation will be completed.

Event Description

Shoulder revision surgery of a smr reverse implant performed on (b)(6) 2021 due to loosening of the smr cementless mini stem (product code 1304.15.110, lot# 1920684 - ster.(b)(4)).According to the reported information, surgeon is unsure of the exact mechanism of implant loosening.The following components were removed: smr cementless mini stem (product code 1304.15.110, lot# 1920684 - ster.(b)(4)).Smr reverse humeral body short (product code 1352.15.005, lot# 2010993 - ster.(b)(4)).Smr reverse hp liner short (product code 1365.09.010, lot # 2005241 - ster.(b)(4)) - product not marketed in the us.New components were implanted and a cemented 12mm stem was used to ensure fixation.Previous surgery was performed on (b)(6) 2020.Patient is a female, (b)(6) years old.According to the complaint source, patient lives a sedentary lifestyle.Event happened in (b)(6).

Manufacturer Narrative

By checking the manufacturing charts of the involved lot#, no pre-existing anomaly was found on a total of 44 items manufactured with the same lot#.According to our records, at least 11 out of 44 cementless mini stems (product code 1304.15.110, lot# 1920684 - ster.2000003) have been implanted and this is the only complaint received on this lot #.Explants were not available to be returned to limacorporate for further analysis.X-rays analysis limacorporate received a total of two x-rays referring to pre-op revision surgery.The x-rays received - dated 01/03/2021 - have been evaluated by a medical consultant.Following, the medical consultant comments: "we can see a cerclage wire around the proximal humerus which tells us there were problems with the implantation of the humeral component, likely a split of the cortex.This will have weakened the proximal humerus structurally and may have contributed to the loosening.The humeral stem in this image prior to revision is not centered in the canal but we do not know whether it was like this at the index procedure.There is nothing obviously remarkable about the glenoid components but the visualization of the glenoid is very limited by the projection of the x-rays.One can see separated pieces of bone/calcification around the proximal humerus which suggests the fixation of tuberosities was not sound.A narrow humerus can be challenging but the canal can be reamed.This lessens the potential for fixation of either cemented or cementless prostheses but in a patient of this age and functional demand i would have chosen a cemented component because it is slightly less diameter and easier to insert.There would have been a lesser chance of a cortical split.I have no experience of nor heard of splitting the cortex other than to explant prostheses.The idea does not appeal, and i would neither do or recommend it.Humeral stem failure is unusual in shoulder arthroplasty.In summary the failure was primarily surgical rather than patient based".Stating that: · check of the manufacturing charts highlighted no anomalies on the total number of components manufactured with lot #1920684; · according to the medical expert, the proximal humerus could have been structurally weakened by a possible humeral component implantation problem on previous surgery; we can conclude that the event was rather surgical related.Pms data according to limacorporate pms data, revision rate of cementless stems - belonging to the family codes 1304.15.Xxx - due to loosening 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.

Event Description

Shoulder revision surgery of a smr reverse implant performed on (b)(6), 2021, due to loosening of the smr cementless mini stem (product code 1304.15.110, lot# 1920684 - ster.2000003).According to the reported information, surgeon is unsure of the exact mechanism of implant loosening.The following components were removed: · smr cementless mini stem (product code 1304.15.110, lot# 1920684 - ster.2000003) · smr reverse humeral body short (product code 1352.15.005, lot# 2010993 - ster.2000230) · smr reverse hp liner short (product code 1365.09.010, lot # 2005241 - ster.2000199) - product not marketed in the us new components were implanted and a cemented 12mm stem was used to ensure fixation.Previous surgery was performed on (b)(6), 2020.Patient is a female, 88 years old.Exact patient's bmi is not known, however it was reported to be 30+.According to the complaint source, patient lives a sedentary lifestyle.Event happened in australia.

• Brand Name: SMR CEMENTLESS MINI STEM
• Type of Device: FINNED HUMERAL STEMS - 60MM (TI6AL4V) DIA.11MM
• Manufacturer (Section D): LIMACORPORATE S.P.A.; via nazionale 52; villanova di san daniele, udine 33038 ; IT 33038
• MDR Report Key: 11847206
• MDR Text Key: 251363795
• Report Number: 3008021110-2021-00037
• 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
• Type of Report: Initial,Followup
• Report Date: 10/15/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/19/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Device Model Number: 1304.15.110
• Device Lot Number: 1920684
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other