MAUDE Adverse Event Report: LIMACORPORATE S.P.A. SMR CEMENTLESS FINNED STEM; FINNED HUMERAL STEMS - 80MM (TI6AL4V) DIA.18MM (HSD-KWT)

Model Number 1304.15.180

Device Problem Microbial Contamination of Device (2303)

Patient Problem Unspecified Infection (1930)

Event Date 09/11/2018

Event Type  Injury  

Manufacturer Narrative

By checking the sterilization charts of all the involved lot #s, no anomaly was found.Thus we can state that the products had been correctly sterilized before being placed on the market.We will submit a final mdr once the investigation will be concluded.

Event Description

According to the info received, the events can be summarized as per following: primary surgery took place on (b)(6) 2013.First revision surgery performed on (b)(6) 2016 (cause for revision is unknown).During this revision surgery the following components had been implanted: smr cementless finned stem, code 1304.15.180, lot#1602493, ster.1600071.Smr reverse humeral body short, code 1352.15.005, lot#1519396, ster.1600059.Smr reverse hp liner short, code 1362.09.010, lot #1517490, ster.1600064 (product not marketed in the usa).Smr uncement.Glenoid # std, code 1375.20.010, lot#1516952, ster.1500395 (product not marketed in the usa).Smr reverse hp glenosph.44 mm, code 1374.50.440, lot#1516534, ster.1500366 (product not marketed in the usa).Bone screw ø6,5 h.20mm, code 8420.15.010, lot# 1601434, ster.1600055.Bone screw ø6,5 h.25mm, code 8420.15.020, lot# 1600130, ster.1600040.Smr connector small std, code 1374.15.310, lot# 1601929, ster.1600054.On (b)(6) 2018, revision surgery took place due to infection: only humeral components had been removed.After specimens analysis, it was found out that the germ responsible was propionibacterium acnes.On (b)(6) 2018 another surgery took place to remove the glenoid-side of the implant.Antibiotic spacer has been inserted.Event happened in (b)(6).

Manufacturer Narrative

Check of sterilization charts: by checking the sterilization charts of all the lot#s involved, no anomaly was found, thus we can state that the products implanted on (b)(6) april 2016 had been correctly sterilized before being placed on the market.Explants analysis: no explants available to be returned to limacorporate.X-rays analysis: only one x-ray dated 31st of august 2018 was received and analyzed by our medical consultant.Following his medical judgement about the case: "p acnes is sadly not uncommon in the shoulder.It is a difficult organism to diagnose and treat.We can see on the x-ray evidence of lysis around the humeral stem.That is always highly suggestive of infection and indeed humeral loosening is infection until proven otherwise.The patient has now had 4 surgical procedures.A hip joint can withstand that but the shoulder is different.One gets to the stage of "too much surgery" and the prospects of a good outcome following further surgical revision is not good both from the point of view of clearing the infection as well as a good clinical outcome.Some patients elect not to have the 2nd stage of revision if the pain is controlled even though the function is poor.I think the important message is that the surgeon should acquaint (tell) the patient with the poor outcomes in this situation so that they are not given the "false promise of hope" with a further revision.It is interesting to see the fixation of the glenoid".According to surgeon's remarks (responsible for the revision surgery performed on 04th of september 2018) "metal back glenoid was very well fixed.Good amount of bone growth of posterior of metal back prosthesis could be noticed".Pictures of the metal back glenoid explanted on (b)(6) 2018 were received and, by a visual analysis, we can confirm surgeon's remarks.Conclusion: with no explants received, a deeper investigation about this case is not possible.Sterilization and manufacturing records of all the components involved were checked and the batches were manufactured/sterilized correctly up to specs and in-line with the relevant checks and tests and no manufacturing/sterilization deviations were reported.Event not product related.Pms data: according to our pms data, smr reverse revision rate due to infection is 0.055%.None of the cases we could investigate were classified as product related.No specific corrective actions for this case.Limacorporate will continue monitoring the market to promptly detect any further similar issue.

Event Description

According to the info received, the events can be summarized as per following: · primary surgery took place on 2nd of march 2013; · first revision surgery performed on the 26th of april 2016 (cause for revision is unknown).During this revision surgery, smr reverse prosthesis was implanted.In details, the following components had been implanted: - stem code 1304.15.180 lot#1602493 ster.1600071; - reverse humeral body code 1352.15.005, lot#1519396 ster.1600059; - liner code 1362.09.010 lot #1517490 ster.1600064; - glenoid metal back code 1375.20.010 lot#1516952 ster.1500395; - glenosphere code 1374.50.440 lot#1516534 ster.1500366; - bone screw code 8420.15.010 lot# 1601434 ster.1600055; - bone screw code 8420.15.020 lot# 1600130 ster.1600040; - connector code 1374.15.310 lot# 1601929 ster.1600054; · on 04th of september 2018, revision surgery took place due to infection: during this revision surgery, only the humeral components were removed.Specimens were taken and pathology results returned with positive growths of propionibacterium acnes.This revision surgery is the subject of this complaint report.· on 11th of september 2018 another surgery took place to remove even the glenoid side of the implant.Antibiotic spacer has been inserted.No info about components implanted once the infection was healed.Event happened in australia.

• Brand Name: SMR CEMENTLESS FINNED STEM
• Type of Device: FINNED HUMERAL STEMS - 80MM (TI6AL4V) DIA.18MM (HSD-KWT)
• Manufacturer (Section D): LIMACORPORATE S.P.A.; via nazionale 52; villanova di san daniele; villanova di san daniele, udine 33038 ; IT 33038
• MDR Report Key: 8000090
• MDR Text Key: 124968467
• Report Number: 3008021110-2018-00093
• 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

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/24/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Device Model Number: 1304.15.180
• Device Lot Number: 1602493
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention