MAUDE Adverse Event Report: LIMACORPORATE S.P.A. CORTICAL BONE SCREW D.4,5 L.36MM; CORTICAL SCREW DIA. 4,5MM L 36MM

Model Number 8431.15.036

Device Problems Break (1069); Loose or Intermittent Connection (1371); Appropriate Term/Code Not Available (3191)

Patient Problems Purulent Discharge (1812); Unspecified Infection (1930)

Event Date 10/13/2021

Event Type  Injury  

Manufacturer Narrative

By checking the sterilization charts of the involved lot #s, no pre-existing anomaly was found on the overall components placed on the market with the same lot #s.By checking the dhr of the screws lot #1702122 and #1511632, no pre-existing anomaly was found on the items placed on the market with the same lot #s.We will submit a final mdr once the investigation will be completed.

Event Description

Shoulder revision surgery performed on (b)(6) 2021 due to loosening of glenoid components.It was reported that both screws were found broken.According to the complaint source, reason for loosening and screws breakage is bone graft reabsorption for a suspected infection.It was reported that pus was found in joint and samples were taken.Additionally, it was reported small metalosis.The following components were explanted: cortical bone screw d.4,5 l.36mm (product code 8431.15.036, lot #1702122 - ster.1700088).Cortical bone screw d.4,5 l.50mm (product code 8431.15.050, lot #1511632 - ster.1700079).Smr glenoid peg tt small-r #m (product code 1375.14.652, lot #1615916 - ster.1600347).Smr glenoid baseplate small-r (product code 1375.15.605, lot #1701021 - ster.1700062).Smr connector small r (product code 1374.15.305, lot #1700078 - ster.1700029).Smr reverse liner + 3 mm (product code 1360.50.015, lot #16at14g - ster.1600219) - product not marketed in the us.Smr glenosphere ø 36mm (product code 1374.09.111, lot #1617992 - ster.1700035) - product not marketed in the us.Humeral stem and humeral body were left in situ.A cta adaptor and a cta head were placed in.According to the reported information, a custom-made glenoid implant was requested.Previous surgery took place on (b)(6) 2017.Patient is a female, (b)(6).No further data available.

Event Description

Shoulder revision surgery of a smr reverse implant performed on (b)(6), 2021, due to loosening of glenoid components.It was reported that both screws were found broken.According to the complaint source, reason for loosening and screws breakage is bone graft reabsorption for a suspected infection.It was reported that pus was found in joint.Samples were taken, however the results are not available.Additionally, it was reported small metalosis.The following components were explanted: · cortical bone screw d.4,5 l.36mm (product code 8431.15.036, lot #1702122 - ster.1700088).· cortical bone screw d.4,5 l.50mm (product code 8431.15.050, lot #1511632 - ster.1700079).· smr glenoid peg tt small-r #m (product code 1375.14.652, lot #1615916 - ster.1600347).· smr glenoid baseplate small-r (product code 1375.15.605, lot #1701021 - ster.1700062).· smr connector small r (product code 1374.15.305, lot #1700078 - ster.1700029).· smr reverse liner + 3 mm (product code 1360.50.015, lot #16at14g - ster.1600219) - product not marketed in the us.· smr glenosphere ø 36mm (product code 1374.09.111, lot #1617992 - ster.1700035) - product not marketed in the us.Humeral stem and humeral body were left in situ.A cta adaptor and a cta head were placed in.According to the reported information, a custom-made glenoid implant was requested.Previous surgery took place on (b)(6), 2017.Patient is a female, 88 years old.No further data available.Event happened in new zealand.

Manufacturer Narrative

Checking the sterilization charts of the involved lot #s, no pre-existing anomaly was found on the overall components placed on the market with the same lot - ster.#s.The products with these lot #s have been properly sterilized before being placed on the market.In addition, checking the manufacturing charts of the involved lot #1511632, no pre-existing anomaly was found on a total of (b)(4) manufactured with the same lot #.By checking the manufacturing charts of the involved lot #1702122 - ster.1700088, no pre-existing anomaly was found on a total of (b)(4) manufactured with the same lot # - ster.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 pre-operative of revision surgery.The x-ray received - dated (b)(6) 2021 - and a picture of the explanted components have been evaluated by a medical consultant.Following, the medical consultant comments: "in my opinion the infection is the underlying cause for revision.This led to implant loosening and instability of the metal back with subsequent screw breakage.Besides the fact that the inferior screw is exceptionally long, i cannot see implant related issues here".Considering that: · checking the sterilization charts, no anomaly was found on the components placed on the market with the same lot - ster.#s · checking the manufacturing charts of bone screws, no anomaly was found on the total number of components manufactured with lots #1511632 and #1702122; · according to the medical consultant, "the infection is the underlying cause for revision"; 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: CORTICAL BONE SCREW D.4,5 L.36MM
• Type of Device: CORTICAL SCREW DIA. 4,5MM L 36MM
• Manufacturer (Section D): LIMACORPORATE S.P.A.; via nazionale 52; villanova di san daniele, udine 33038 ; IT 33038
• MDR Report Key: 12710259
• MDR Text Key: 278772255
• Report Number: 3008021110-2021-00082
• Device Sequence Number: 1
• Product Code: MBF
• Combination Product (y/n): N
• PMA/PMN Number: K191746
• 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: 06/13/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/28/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Model Number: 8431.15.036
• Device Catalogue Number: 8431.15.036
• Device Lot Number: 1702122
• 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): Required Intervention