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 Loose or Intermittent Connection (1371)

Patient Problem Unspecified Infection (1930)

Event Date 12/18/2020

Event Type  Injury  

Manufacturer Narrative

We are currently investigate the case at the best of our possibilities.We will send a final incident report once the investigation will be concluded.

Event Description

Revision surgery of a smr reverse prosthesis (with customized glenoid component found to be loose) due to deep infection performed on (b)(6) 2020.During the revision surgery, all the components previously implanted during the previous surgery performed on (b)(6) 2020 have been explanted.Following, the product details of the explants: smr cementless finned stem, code 1304.15.140, lot# 1917902, ster.2000046; smr reverse humeral body, code 1352.20.010, lot# 2011653, ster.2000274; smr reverse liner standard, code 1360.50.010, lot# 19at1km, ster.1900360; smr connector small std, code 1374.15.310, lot# 1916953, ster.1900376; smr eccent.Glenosphere ø 36mm, code 1376.09.031, lot# 1912500, ster.2000020; bone screw d.4,5 l.26mm, code 8431.15.026, lot# 1921132, ster.1900441; bone screw d.4,5 l.28mm, code 8431.15.028, lot# 1920934, ster.1900462; bone screw d.4,5 l.34mm, code 8431.15.034, lot# 1912668, ster.1900305; customized glenoid, code 9961714y57000, lot# 2017117, ster.2000292.According to the info reported by the complaint source, pathogen responsible for the infection is unknown and patient suffers for parkinson's disease.No implants implanted during the revision surgery.Event happened in (b)(6).

Event Description

Shoulder revision surgery of a smr reverse prosthesis performed on (b)(6), 2020, due to deep infection.It was reported that the site developed redness and swelling which had progressed to deep infection.According to the complaint source, the pathogen responsible for the infection is unknown.It was reported that the customized glenoid component was found to be loose, whereas the humerus was well fixed.All components previously implanted had been explanted.Following, the product details of the explants: · smr cementless finned stem, code 1304.15.140, lot# 1917902, ster.2000046; · smr reverse humeral body, code 1352.20.010, lot# 2011653, ster.2000274 - product not sold in the us; · smr reverse liner standard, code 1360.50.010, lot# 19at1km, ster.1900360 - product not sold in the us; · smr connector small std, code 1374.15.310, lot# 1916953, ster.1900376; · smr eccent.Glenosphere ø 36mm, code 1376.09.031, lot# 1921500, ster.2000020; · bone screw d.4,5 l.26mm, code 8431.15.026, lot# 1921132, ster.1900441; · bone screw d.4,5 l.28mm, code 8431.15.028, lot# 1920934, ster.1900462; · bone screw d.4,5 l.34mm, code 8431.15.034, lot# 1912668, ster.1900305; · customized glenoid, code 9617.14.Y57, lot# 2017117, ster.2000292.No implants were implanted during the revision surgery.Previous surgery was performed on (b)(6), 2020.Patient is a female, 77 years old.It was reported that she suffers of parkinson's disease.Event happened in new zealand.

Manufacturer Narrative

By checking the sterilization charts of the involved lot #s, no pre-existing anomaly was found on the overall number.Therefore, all the products with these lot #s have been properly sterilized before being placed on the market.Explants analysis: the items involved were not available to be returned to limacorporate for further analysis.X-rays analysis: limacorporate received one x-ray referring to post-operative previous surgery.The x-ray received - exact date not known - has been evaluated by a medical consultant.Following, the medical consultant comments: "the image i think is post operative the revision procedure on the (b)(6).There are long standing changes in the antero-inferior glenoid, and obviously there has been at least one procedure prior to that revision.We do not have any other details but with 2 prior procedures the risk of infection is significantly increased.I do not see any features of the positioning of the implants that is concerning and at that stage there is no obvious bony change that would be consistent with infection.With the limited information available we conclude that the infection occurred in association with the revision procedure on the (b)(6).Explanting all prosthetic material is appropriate.There is no mention of a prostalac being used which would be a reasonable option".Considering that: · check of the sterilization charts highlighted no anomalies on the components manufactured with the same lot #s; · according to the medical consultant "with the limited information available we conclude that the infection occurred in association with the revision procedure on the (b)(6)."; we can state that the event was not product related.Pms data according to limacorporate pms data, revision rate of smr reverse prosthesis due to infection 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.

• 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: 11046517
• MDR Text Key: 223183908
• Report Number: 3008021110-2020-00120
• 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: 02/07/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/21/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Model Number: 1304.15.140
• Device Lot Number: 1917902
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 12/18/2020
• 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