MAUDE Adverse Event Report: LIMACORPORATE S.P.A. CORTICAL BONE SCREW D.4,5 L.20MM; CORTICAL SCREW DIA. 4,5MM L 20MM

Model Number 8431.15.020

Device Problem Patient Device Interaction Problem (4001)

Patient Problem Implant Pain (4561)

Event Date 04/08/2024

Event Type  Injury  

Manufacturer Narrative

Checking the manufacturing charts of involved lots#: 2204927, #2106512 and #: 2108017, no pre-existing anomalies were found on the 70, 120 and 120 components manufactured with those lot#s respectively.This is the first and only complaint received on 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 on (b)(6) 2024, due to pain.It was stated that the patient started experiencing pain, and the surgeon hypothesized that the superior bone screw on the glenoid was the cause for the pain.No traumatic event was reported.After removing the superior bone screw, the whole metalback implant was found to be loose.All the glenoid components were removed: smr uncemented glenoid #small-r (product code: 1375.20.005, lot#: 2204927 - ster.2200101) product not sold in the us.Cortical bone screw d.4,5 l.20mm (product code: 8431.15.020, lot#: 2106512 - ster.2100140).Cortical bone screw d.5 l.36 mm (product code: 8432.15.036, lot#: 2108017 - ster.2100140).Smr reverse hp glenosphere 40 mm (product code: 1374.50.400, lot#: 2204755 - ster.2200065) product not sold in the us.Smr small-r connector +2 (product code: 1374.15.312, lot#: 2208272 - ster.2200107).Smr reverse hp liner short (product code: 1365.09.010, lot#: 2125746 - ster.2200042) product not sold in the us.The site was debrided and thoroughly washed out, and an adaptor and humeral head temporarily implanted.Infection might be present.Previous surgery on (b)(6) 2022.Patient is a female, 76 years old.Event happened in (b)(6).

Event Description

Shoulder revision surgery of a smr reverse prosthesis performed on april 8th, 2024, due to pain and loosening.It was stated that the patient started experiencing pain, and the surgeon hypothesized that the superior bone screw on the glenoid (the one of 36mm) was the cause for the pain.No traumatic event was reported.After removing the superior bone screw, the whole metalback implant was found to be loose.All the glenoid components were removed: · smr uncemented glenoid #small-r (product code 1375.20.005, lot #2204927 - ster.2200101) - product not sold in the us.· cortical bone screw d.4,5 l.20mm (product code 8431.15.020, lot #2106512 - ster.2100140).· cortical bone screw d.5 l.36 mm (product code 8432.15.036, lot #2108017 - ster.2100140).· smr reverse hp glenosphere 40 mm (product code 1374.50.400, lot #2204755 - ster.2200065).- product not sold in the us · smr small-r connector +2 (product code 1374.15.312, lot #2208272 - ster.2200107).· smr reverse hp liner short (product code 1365.09.010, lot #2125746 - ster.2200042).- product not sold in the us.The site was debrided and thoroughly washed out, and an adaptor and humeral head temporarily implanted.Infection was suspected by the surgeon on inspection of the wound and because the metalback was loose on the glenoid.Specimens were taken however results aren't available.Previous surgery (it was a primary) took place on (b)(6) 2022.Patient is a female, 76 years old.Asa class 2, bmi of 37 at the time of the previous surgery.Event happened in new zealand.

Manufacturer Narrative

Checking the manufacturing charts of involved lots #2204927, #2106512 and #2108017, no pre-existing anomalies were found on the 70, 120 and 120 components manufactured with those lot #s respectively.This is the first and only complaint received on those lot #s.Further checking the sterilization charts of the involved lot #s, no pre-existing anomaly was found on the overall number.Therefore, all products with those lot #s have been properly sterilized before being placed on the market.Device analysis: items involved weren't available to be returned to limacorporate for further analysis.No additional details were available on this post-operative issue, specifically no x-rays were available for the investigation.Considering that: · check of manufacturing charts highlighted no anomalies on components manufactured with lots #2204927, #2106512 and #2108017; · check of sterilization charts proved that all products with those lot #s have been properly sterilized before being placed on the market; · according to the received information, the surgeon hypothesized that the superior bone screw was the cause for the pain, however removing it, the whole metalback implant was found to be loose.The surgeon suspected that there was infection, however specimens' results aren't available; we aren't able to draw a definitive root cause for the event, still we can state that it was not product related.Pms data: according to limacorporate pms data, the revision rate of smr reverse prostheses due to pain is 0.03%.Based on the root cause analysis performed and according to the relevant pms data, no corrective actions are required for this specific case.Limacorporate continues monitoring the market to promptly detect any further similar issue.Note: this is a final mdr.

• Brand Name: CORTICAL BONE SCREW D.4,5 L.20MM
• Type of Device: CORTICAL SCREW DIA. 4,5MM L 20MM
• Manufacturer (Section D): LIMACORPORATE S.P.A.; via nazionale 52; villanova di san daniele, udine 33038 ; IT 33038
• MDR Report Key: 19170881
• MDR Text Key: 340900268
• Report Number: 3008021110-2024-00038
• Device Sequence Number: 1
• Product Code: PHX
• Combination Product (y/n): N
• PMA/PMN Number: K200171
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 04/23/2024

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: 8431.15.020
• Device Lot Number: 2106512
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 04/24/2024
• 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