MAUDE Adverse Event Report: LIMACORPORATE S.P.A. SMR CEMENTLESS FINNED STEM; FINNED HUMERAL STEMS - 80MM (TI6AL4V) DIA.20MM

Model Number 1304.15.200

Device Problems Loose or Intermittent Connection (1371); Appropriate Term/Code Not Available (3191)

Patient Problem Unspecified Infection (1930)

Event Date 07/21/2021

Event Type  Injury  

Manufacturer Narrative

By checking the sterilization charts of the involved lot #s, no pre-existing anomaly was found on the components with the same lot #s.We will submit a final report once the investigation will be completed.

Event Description

Shoulder revision surgery of a smr reverse implant performed on (b)(6) 2021, due to suspected infection.According to the reported information, the glenoid component was loose.All implants had been removed: smr cementless finned stem (product code 1304.15.200, lot #2013346 - ster.2000327).Smr uncemented glenoid # std (product code 1375.20.010, lot #2019066 - ster.2000397) - product not marketed in the us.Smr reverse humeral body (product code 1352.20.010.Lot #2101507 - ster.2100089) - product not marketed in the us.Smr reverse hp lat.Liner long (product code 1365.09.120, lot #2005954 - ster.2000208) - product not marketed in the us.Smr connector small std (product code 1374.15.310, lot #2025211 - ster.2100084).Smr reverse hp glenosphere 40 mm (product code 1374.50.400, lot #2100613 - ster.2100035) - product not marketed in the us.Bone screw ø6,5 h.25mm (product code 8420.15.020, lot #2101276 - ster.2100048).Bone screw ø6,5 h.35mm (product code 8420.15.040, lot #1922838 - ster.2000017).An antibiotic cement spacer was inserted.Previous surgery took place on (b)(6) 2021.Patient is a male, (b)(6) years old.It was reported he is obese and has liver disease.Low level of activity.Event happened in (b)(6).

Event Description

Shoulder revision surgery of a smr reverse implant performed on (b)(6), 2021, due to suspected infection.According to the reported information, the glenoid component was loose.All implants had been removed: · smr cementless finned stem (product code 1304.15.200, lot #2013346 - ster.2000327).· smr uncemented glenoid # std (product code 1375.20.010, lot #2019066 - ster.2000397) - product not marketed in the us.· smr reverse humeral body (product code 1352.20.010.Lot #2101507 - ster.2100089) - product not marketed in the us.· smr reverse hp lat.Liner long (product code 1365.09.120, lot #2005954 - ster.2000208) - product not marketed in the us.· smr connector small std (product code 1374.15.310, lot #2025211 - ster.2100084).· smr reverse hp glenosphere 40 mm (product code 1374.50.400, lot #2100613 - ster.2100035) - product not marketed in the us.· bone screw ø6,5 h.25mm (product code 8420.15.020, lot #2101276 - ster.2100048).· bone screw ø6,5 h.35mm (product code 8420.15.040, lot #1922838 - ster.2000017).An antibiotic cement spacer was inserted.No further details on the infection were available.Previous surgery took place on (b)(6), 2021.Patient is a male, 66 years old.It was reported he is obese and has liver disease.Low level of activity.Event happened in australia.

Manufacturer Narrative

By checking the sterilization charts of the involved lot #s, no pre-existing anomaly was found on the overall number.All the products placed on the market with these lot #s have been properly sterilized before being placed on the market.Explanted items 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-operative revision surgery.The x-rays received - dated (b)(6) 2021 - have been evaluated by a medical consultant.Following, the medical consultant comments: "the index surgery was for a fracture so we cannot criticize selection of the patient with serious co-morbidities (which i am assuming).The xray is terrible! it shows some fragments of bone which i assume are tuberosities because the humeral body has no adjacent bone.I am guessing that these tuberosities were not reattached which if so would be an error but would not prevent infection.The loosening may well be entirely due to infection but infection does not necessarily go onto macroscopic failure of the glenoid complex.In summary: in a patient with co-morbidities that might compromise immune status "patient factors" have to be a significant contributor to the early post operative infection.If the tuberosities were not reattached i would be critical of that but that would not prevent the failure of fixation of the glenoid".Considering that: · check of sterilization charts highlighted no anomalies on the total number of components manufactured with the involved lot #s; · according to the medical consultant, "in a patient with co-morbidities that might compromise immune status "patient factors" have to be a significant contributor to the early post operative infection"; 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.20MM
• Manufacturer (Section D): LIMACORPORATE S.P.A.; via nazionale 52; villanova di san daniele, udine 33038 ; IT 33038
• MDR Report Key: 12244217
• MDR Text Key: 264262800
• Report Number: 3008021110-2021-00058
• 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: 12/07/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/29/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Model Number: 1304.15.200
• Device Lot Number: 2013346
• Is the Reporter a Health Professional?: No
• 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): Other