MAUDE Adverse Event Report: LIMACORPORATE S.P.A. SMR CEMENTLESS FINNED STEM; FINNED HUMERAL STEMS - 80MM (TI6AL4V) DIA.14MM

Model Number 1304.15.140

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problems Unspecified Infection (1930); Pain (1994)

Event Date 10/01/2020

Event Type  Injury  

Manufacturer Narrative

By checking the sterilization charts of the involved products, no pre-existing anomalies were found thus we can state that all the components had been regularly sterilized before being placed on the market.This is the first and only complaint received on these lot #s.We will submit a final mdr once the investigation will be completed.

Event Description

Shoulder revision surgery due to pain performed on (b)(6) 2020.The following components were explanted: smr cementless finned stem (product code 1304.15.140, lot# 1810121 - ster.(b)(4)).Smr reverse humeral body short (product code 1352.15.005, lot# 1813644 - ster.(b)(4)).Smr reverse liner standard (product code 1360.50.010, lot# 17at21t - ster.(b)(4)).Smr connector small r (product code 1374.15.305, lot# 1817954 - ster.(b)(4)).Smr eccent.Glenosphere ø 36mm (product code 1376.09.031, lot# 1805067 - ster.(b)(4)).The baseplate was left implanted.Similar components were implanted.It was reported that there was presence of infection due to p.Acnes.Previous surgery took place on (b)(6) 2019.Patient is a female, born on (b)(6).Event happened in (b)(6).

Event Description

Revision surgery of a smr reverse prosthesis performed on october 1st, 2020 due to infection.The following components were explanted: smr cementless finned stem (product code 1304.15.140, lot# 1810121 - ster.1800249).Smr reverse humeral body short (product code 1352.15.005, lot# 1813644 - ster.1800310).Smr reverse liner standard (product code 1360.50.010, lot# 17at21t - ster.1800240).Smr connector small r (product code 1374.15.305, lot# 1817954 - ster.1800396).Smr eccent.Glenosphere ø 36mm (product code 1376.09.031, lot# 1805067 - ster.1800189).The baseplate was left implanted.It was reported that there was presence of infection due to p.Acnes.Previous surgery took place on (b)(6) 2019.Patient is a female, born on (b)(6)1939.No additional clinical info available.Event happened in australia.

Manufacturer Narrative

By checking the sterilization charts of the involved products, no pre-existing anomalies were found thus we can state that all the components had been regularly sterilized before being placed on the market.This is the first and only complaint received on these lot #s.Explants analysis: explanted component not available to be sent back to limacorporate for further analysis.X-rays analysis: we received some pre-op x-rays taken on september 1st, 2020.We asked for a clinical opinion about the case to our medical consultant.Following his statement: "the x rays show no issue with positioning of the components.Nor is there any overt x-ray evidence of lysis except the first image where there is possibly some minor lysis around the inferior screw? what is striking is the humeral stem and metaphysis remodelling change after little over a year and half since the index procedure.There has been no evidence to relate these changes to infection.It is as far as we know a function of stemmed prostheses and without going into detail suffice to say is not surgeon related.It also is not "brand specific".The surgeon has made a judgement to leave the baseplate in situ.We do not know further detail eg.Whether this was a "2 stage procedure" in the one surgical event or other.That said i would still have concern with this specific pathogen which is very difficult to eradicate and the choice to leave the baseplate and not do a formal 2 stage procedure.Again, as mentioned, it is a difficult infection to deal with whatever procedure is done so i am not overly critical and especially as there is no details.In summary the patient has suffered a postoperative prosthetic joint infection with cuti-bacterium acnes and this is a well recognised complication and risk of shoulder arthroplasty and more so in reverse arthroplasty".Stating that: no pre-existing anomalies were found by checking the sterilization charts of the involved products; the medical consultant highlighted that ".The patient has suffered a postoperative prosthetic joint infection with cuti-bacterium acnes and this is a well recognised complication and risk of shoulder arthroplasty and more so in reverse arthroplasty" no specific root cause can be assigned to this case.Based on the investigation performed we cannot classify this event as product related.Pms data: revision rate related to infection of smr reverse prosthesis is 0.06%.No specific corrective actions for this case.Limacorporate will continue monitoring the market to promptly detect any further similar issue.Note: this is a final mdr.

• Brand Name: SMR CEMENTLESS FINNED STEM
• Type of Device: FINNED HUMERAL STEMS - 80MM (TI6AL4V) DIA.14MM
• Manufacturer (Section D): LIMACORPORATE S.P.A.; via nazionale 52; villanova di san daniele, udine 33038 ; IT 33038
• MDR Report Key: 10661057
• MDR Text Key: 211227143
• Report Number: 3008021110-2020-00083
• 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: 04/13/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/12/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Device Model Number: 1304.15.140
• Device Lot Number: 1810121
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention