MAUDE Adverse Event Report: LIMACORPORATE S.P.A. BONE SCREW Ø6,5 H.25MM; BONE SCREWS DIA. 6.5 X H. 25 MM

Model Number 8420.15.020

Device Problems Loose or Intermittent Connection (1371); Device Slipped (1584); Appropriate Term/Code Not Available (3191)

Patient Problems Pain (1994); Metal Related Pathology (4530)

Event Date 11/12/2021

Event Type  Injury  

Event Description

Shoulder revision surgery performed on (b)(6) 2021, due to patient experiencing ongoing pain for a period of months.It was reported that there was also radiographic evidence of loosening around the peg of the baseplate.According to the complaint source, the patient was monitored for some time, however his pain did not subside, and decision was made to revise the shoulder implant.According to the complaint source, upon glenosphere removal it was discovered that the inferior screw had backed out a few mm.However, the screw was completely in bone, and it disproved the first theory of potential impingement of the humeral body upon the inferior screw in adduction as to the cause of pain.It was reported that upon removal of the baseplate, there was no evidence of bone on growth at all.The following components were explanted: smr reverse hp lateralizing liner medium ((b)(4), lot #2005682 - ster.2000220) - product not sold in the us.Smr connector small std ((b)(4), lot #2016888 - ster.2000317).Smr reverse hp glenosphere 44 mm ((b)(4), lot #2011795 - ster.2000229) - product not sold in the us.Smr uncemented glenoid # std ((b)(4), lot #2016683 - ster.2000324) - product not sold in the us bone screw ø6,5 h.25mm ((b)(4), lot #2014529 - ster.2000278).Bone screw ø6,5 h.35mm ((b)(4), lot #2017881 - ster.2000341).According to the reported information, samples were taken during surgery as there was some evidence of a potential infection (some metalosis and discoloured tissue around the baseplate).According to the complaint source, no pathogen has grown as yet.A tt standard baseplate was implanted with a medium glenoid peg tt.Two screws were inserted (h.25mm and h.35mm) with strong implant stability.A 44mm reverse hp correction glenosphere was implanted with a 44mm reverse hp medium lateralizing liner.Previous surgery took place on (b)(6) 2020.Patient is a male, (b)(6).It was reported he has a bmi of 35.Event happened in (b)(6).

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 involved lot #2016683, no pre-existing anomaly was found on the items placed on the market with the same lot #.This is the first and only complaint received on this lot #.We will submit a final mdr once the investigation will be completed.

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 involved lot #2016683, no pre-existing anomaly was found on the items placed on the market with the same lot #.This is the first and only complaint received on this lot #.We will submit a final mdr once the investigation will be completed.

Event Description

Shoulder revision surgery performed on (b)(6) 2021, due to patient experiencing ongoing pain for a period of months.It was reported that there was also radiographic evidence of loosening around the peg of the baseplate.According to the complaint source, the patient was monitored for some time, however his pain did not subside, and decision was made to revise the shoulder implant.According to the complaint source, upon glenosphere removal it was discovered that the inferior screw had backed out a few mm.However, the screw was completely in bone, and it disproved the first theory of potential impingement of the humeral body upon the inferior screw in adduction as to the cause of pain.It was reported that upon removal of the baseplate, there was no evidence of bone on growth at all.The following components were explanted: smr reverse hp lateralizing liner medium (product code 1362.09.115, lot #2005682 - ster.2000220) - product not sold in the us · smr connector small std (product code 1374.15.310, lot #2016888 - ster.2000317) · smr reverse hp glenosphere 44 mm (product code 1374.50.440, lot #2011795 - ster.2000229) - product not sold in the us · smr uncemented glenoid # std (product code 1375.20.010, lot #2016683 - ster.2000324) - product not sold in the us · bone screw ø6,5 h.25mm (product code 8420.15.020, lot #2014529 - ster.2000278) · bone screw ø6,5 h.35mm (product code 8420.15.040, lot #2017881 - ster.2000341).According to the reported information, samples were taken during surgery as there was some evidence of a potential infection (some metalosis and discoloured tissue around the baseplate).According to the complaint source, no pathogen has grown as yet.A tt standard baseplate was implanted with a medium glenoid peg tt.Two screws were inserted (h.25mm and h.35mm) with strong implant stability.A 44mm reverse hp correction glenosphere was implanted with a 44mm reverse hp medium lateralizing liner.Previous surgery took place on (b)(6) 2020.Patient is a male, (b)(6).It was reported he has a bmi of 35.Event happened in (b)(6).

Event Description

Shoulder revision surgery performed on (b)(6), 2021, due to patient experiencing ongoing pain for a period of months.It was reported that there was also radiographic evidence of loosening around the peg of the smr uncemented glenoid # std (product code (b)(4), lot #2016683 - ster.2000324).According to the complaint source, the patient was monitored for some time, however his pain did not subside, and decision was made to revise the shoulder implant.According to the complaint source, upon glenosphere removal it was discovered that the inferior screw had backed out a few mm.However, the screw was completely in bone, and it disproved the first theory of potential impingement of the humeral body upon the inferior screw in adduction as to the cause of pain.It was reported that upon removal of the baseplate, there was no evidence of bone on growth at all.The following components were explanted: · smr reverse hp lateralizing liner medium (product code (b)(4), lot #2005682 - ster.2000220) - product not sold in the us.· smr connector small std (product code (b)(4), lot #2016888 - ster.2000317).· smr reverse hp glenosphere 44 mm (product code (b)(4), lot #2011795 - ster.2000229) - product not sold in the us.· smr uncemented glenoid # std (product code (b)(4), lot #2016683 - ster.2000324) - product not sold in the us.· bone screw ø6,5 h.25mm (product code (b)(4), lot #2014529 - ster.2000278).· bone screw ø6,5 h.35mm (product code (b)(4), lot #2017881 - ster.2000341).According to the reported information, samples were taken during surgery as there was some evidence of a potential infection (some metalosis and discoloured tissue around the baseplate).According to the complaint source, no pathogen had grown on the days following the surgery, however no further update was available.A tt standard baseplate was implanted with a medium glenoid peg tt.Two screws were inserted (h.25mm and h.35mm) with strong implant stability.A 44mm reverse hp correction glenosphere was implanted with a 44mm reverse hp medium lateralizing liner.Previous surgery took place on (b)(6), 2020.Patient is a male, 71 years old.It was reported he has a bmi of 35.Event happened in australia.

Manufacturer Narrative

Checking the manufacturing charts of lot #2016683, no pre-existing anomaly was found on a total of (b)(4) manufactured with the same lot #.According to our records, at least (b)(4) glenoid baseplates with lot #2016683 - ster.2000324 have been implanted and this is the only complaint received on this lot #.Additionally, checking the sterilization charts of the involved lot #s, no pre-existing anomaly was found on the overall number.Therefore, all the products with those lot #s have been properly sterilized before being placed on the market.Explants analysis: items involved 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 - and a picture of the implanted baseplate have been evaluated by a medical consultant.Following, the medical consultant comments: "the preop radiographs show osteolysis around the peg as an indication for aseptic loosening.The inferior screw is pointed very much downwards and the angle of the baseplate certainly is not oriented towards the floor (negative inclination) as it should be.Usually, this is not causative for implant loosening, but it certainly is unfavourable.I do not see any sign of implant related issues.The reason for revision probably is aseptic loosening which is a fateful event which maybe has been facilitated by surgical imperfection".Taking into consideration that: · check of the manufacturing charts highlighted no anomalies on the total number of components manufactured with lot #2016683; · according to the complaint source upon removal of the baseplate, there was no evidence of bone on growth; · it was reported that samples were taken during surgery as there was some evidence of a potential infection, however no pathogen had grown on the days following the revision; · according to the medical consultant the glenoid baseplate positioning is sub-optimal and "the reason for revision probably is aseptic loosening which is a fateful event which maybe has been facilitated by surgical imperfection"; we can state that the event was not product related.Pms data: according to limacorporate pms data, revision rate of glenoid baseplates - belonging to the family codes 1375.20.Xxx and 1375.21.Xxx - due to loosening 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: BONE SCREW Ø6,5 H.25MM
• Type of Device: BONE SCREWS DIA. 6.5 X H. 25 MM
• Manufacturer (Section D): LIMACORPORATE S.P.A.; via nazionale 52; villanova di san daniele, udine 33038 ; IT 33038
• MDR Report Key: 12868969
• MDR Text Key: 285940847
• Report Number: 3008021110-2021-00093
• Device Sequence Number: 1
• Product Code: LPH
• Combination Product (y/n): N
• PMA/PMN Number: K172456
• 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: 03/03/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/24/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Model Number: 8420.15.020
• Device Lot Number: 2014529
• 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