MAUDE Adverse Event Report: LIMACORPORATE S.P.A. SMR CEMENTLESS FINNED STEM; FINNED HUMERAL STEMS - 80MM (TI6AL4V) DIA.15MM

Model Number 1304.15.150

Device Problem Patient Device Interaction Problem (4001)

Event Type  Injury  

Manufacturer Narrative

Checking the sterilization charts of the involved lot #s, no pre-existing anomalies were found on the components sterilized with those lot #s.We submit a final mdr as soon as the investigation is complete.

Event Description

Shoulder revision surgery of a smr reverse prosthesis performed in (b)(6) 2022 due to infection.All components were removed: smr cementless finned stem (product code 1304.15.150, lot #1506707 - ster.1500184).Smr reverse finned humeral body (product code 1352.15.050, lot #1503836 - ster.1500127).Smr reverse hp liner short (product code 1365.09.010, lot #1503182 - ster.1500111) - product not sold in the us.Smr connector small r (product code 1374.15.305, lot #1503971 - ster.1500111).Smr reverse hp glenosphere 40 mm (product code 1374.50.400, lot #1508994 - ster.1500210) - product not sold in the us.Smr uncemented glenoid #small-r (product code 1375.20.005, lot #1504297 - ster.1500185) - product not sold in the us.Bone screw ø6,5 h.20mm (product code 8420.15.010, lot #1507396 - ster.1500202).Bone screw ø6,5 h.25mm (product code 8420.15.020, lot #1408524 - ster.1500187).The smr reverse prosthesis was implanted on (b)(6) 2015.Between october and (b)(6) 2022, the patient underwent a total of three surgeries to remove the smr reverse implanted, washout, and place in an antibiotic spacer (surgeries exact dates are unknown).On (b)(6) 2023, patient was revised to place a new reverse configuration in.Patient is a female.It was reported she has other health issues.Event happened in australia.

Event Description

Shoulder revision surgery of a smr reverse prosthesis performed in october 2022 due to infection.All components were removed: smr cementless finned stem (product code 1304.15.150, lot #1506707 - ster.1500184) smr reverse finned humeral body (product code 1352.15.050, lot #1503836 - ster.1500127) smr reverse hp liner short (product code 1365.09.010, lot #1503182 - ster.1500111) - product not sold in the us.Smr connector small r (product code 1374.15.305, lot #1503971 - ster.1500111).Smr reverse hp glenosphere 40 mm (product code 1374.50.400, lot #1508994 - ster.1500210) - product not sold in the us.Smr uncemented glenoid #small-r (product code 1375.20.005, lot #1504297 - ster.1500185) - product not sold in the us bone screw ø6,5 h.20mm (product code 8420.15.010, lot #1507396 - ster.1500202).Bone screw ø6,5 h.25mm (product code 8420.15.020, lot #1408524 - ster.1500187).The smr reverse prosthesis was implanted on (b)(6), 2015.Between october and november 2022, the patient underwent a total of three surgeries to remove the smr reverse implanted, washout, and place in an antibiotic spacer (surgeries accurate dates are unknown).On (b)(6), 2023, patient was revised to place a new reverse configuration in.According to the received information, patient has a chronic infection from enterobacter cloacae that was consequently treated.Patient is a female, 90 years old.It was reported she suffers from af (atrial fibrillation).Event happened in australia.

Manufacturer Narrative

Checking the sterilization charts of the involved lot #s, no pre-existing anomaly was found on the devices.Therefore, the products with these lot #s have been properly sterilized before being placed on the market.The items involved were not available to be returned to limacorporate for further analysis.No additional details were available on this post-operative issue, specifically no pre-operative nor post-operative x-rays related to the revision surgery were accessible for analysis.Based on the very few information received, we are not able to further investigate the root cause of the event.However, considering that the check of the sterilization charts highlighted no anomalies on the components manufactured with the involved lot #s, we can state that the event was not product related.Pms data.According to limacorporate pms data, revision rate of smr reverse implants due to infection is 0.077%.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 final mdr.

• Brand Name: SMR CEMENTLESS FINNED STEM
• Type of Device: FINNED HUMERAL STEMS - 80MM (TI6AL4V) DIA.15MM
• Manufacturer (Section D): LIMACORPORATE S.P.A.; via nazionale 52; villanova di san daniele, udine 33038 ; IT 33038
• MDR Report Key: 16815287
• MDR Text Key: 314008631
• Report Number: 3008021110-2023-00045
• 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: 07/18/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Model Number: 1304.15.150
• Device Lot Number: 1506707
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 04/26/2023
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 07/21/2023
• 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