MAUDE Adverse Event Report: LIMACORPORATE S.P.A. SMR GLENOSPHERE Ø40MM

Model Number 1374.09.120

Device Problems Loose or Intermittent Connection (1371); Device Dislodged or Dislocated (2923); Appropriate Term/Code Not Available (3191)

Patient Problem Pain (1994)

Event Date 06/23/2021

Event Type  Injury  

Event Description

Revision surgery of the left shoulder performed on (b)(6) 2021, due to dislocation and loosening of the glenoid components.According to the complaint source, the patient began experiencing increased pain, instability, and subluxation in (b)(6) 2019.It was reported that intraoperative evaluations revealed loosening of the existing glenoid baseplate and peg.The cause of loosening is unknown.According to the complaint source, inspection of the joint did not reveal any infection.It was reported that according to the surgeon the synovial fluid was normal and there was no purulence.The following components were explanted and replaced: smr humeral extension + 9 mm (product code 1352.15.001, lot #1800447- ster.1800062).Smr reverse liner +6mm d.40mm (product code 1365.50.820, lot #16at1yp - ster.1700073).Smr glenosphere ø40mm (product code 1374.09.120, lot #1614751 - ster.1600304).Smr glenoid peg tt s/std/l #l (product code 1375.14.663, lot #1602897 - ster.1700012).Smr glenoid baseplate standard (product code 1375.15.610, lot #1506738 - ster.1500218).Bone screw ø6,5 h.30mm (product code 8420.15.030, lot #1711897 - ster.1700347).Bone screw ø6,5 h.30mm (product code 8420.15.030, lot #1801293 - ster.1800061).Patient is a male, (b)(6).This is the second revision surgery for patient's left shoulder.History of shoulder surgeries as follows: implant of competitor's prosthesis (date unknown).First revision surgery performed on (b)(6) 2018, during which the lima smr reverse shoulder was implanted.Reason for revision not known.Second revision surgery performed on (b)(6) 2021, due to dislocation and loosening of the glenoid components (herein reported).Patient's right shoulder was revised on (b)(6) 2019, due to loosening of the glenoid component.The revision was registered as complaint (b)(4) and reported to the fda by mfr #3008021110-2021-00020.Event happened in the u.S.

Manufacturer Narrative

We will submit a final mdr as soon as the investigation is closed.

Manufacturer Narrative

Investigation: by checking the manufacturing charts of the involved lot number 1614751, no pre-existing anomaly was found on a total of (b)(4) items manufactured with the same lot number.According to our records, at least 3 out of 11 glenospheres with lot number 1614751, sterilization number (b)(4) have been implanted and this is the only complaint received on this lot number.By checking the manufacturing charts of the involved lot number 1602897, no pre-existing anomaly was found on a total of (b)(4) items manufactured with the same lot number.According to our records, at least 22 out of 29 glenoid pegs with lot number 1602897, sterilization (b)(4) have been implanted and this is the only complaint received on this lot number.By checking the manufacturing charts of the involved lot number 1506738, no pre-existing anomaly that could have contributed to the event was found on a total of 30 items manufactured with the same lot number.According to our records, at least 28 out of 30 baseplates with lot number 1506738, sterilization (b)(4) have been implanted and this is the only complaint received on this lot number.No additional details were available on this post-operative issue, specifically the following information was requested to the complaint source, but it was not available: · pre-operative x-rays related to the revision surgery; · post-operative x-rays related to the revision surgery; · picture of explanted items.Based on the very few information received, we are not able to further investigate the root cause of the event.However, stating that check of the manufacturing charts highlighted no anomalies on the total number of components manufactured with lots number 1614751, number 1602897 and number 1506738, we can suppose that the event was not product related.Pms data: according to limacorporate pms data, revision rate of smr glenosphere belonging to the family product codes 1374.09.Xxx, 1376.09.Xxx, 1374.15.Xxx, 1376.15.Xxx due to dislocation and loosening is around 0.07%.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.

Event Description

Revision surgery of the left shoulder performed on (b)(6) 2021, due to dislocation and loosening of the glenoid components.According to the complaint source, the patient began experiencing increased pain, instability, and subluxation in may 2019.It was reported that intraoperative evaluations revealed loosening of the existing glenoid baseplate and peg.The cause of loosening is unknown.According to the complaint source, inspection of the joint did not reveal any infection.It was reported that according to the surgeon the synovial fluid was normal and there was no purulence.The following components were explanted: · smr humeral extension + 9 mm (product code 1352.15.001, lot number 1800447, sterilization (b)(4)).· smr reverse liner +6mm d.40mm (product code 1365.50.820, lot number 16at1yp, sterilization (b)(4)).· smr glenosphere ø40mm (product code 1374.09.120, lot number 1614751, sterilization (b)(4)).· smr glenoid peg tt s/std/l #l (product code 1375.14.663, lot number 1602897, sterilization (b)(4)) · smr glenoid baseplate standard (product code 1375.15.610, lot number 1506738, sterilization (b)(4)) · bone screw ø6,5 h.30mm (product code 8420.15.030, lot number 1711897, sterilization (b)(4) ) · bone screw ø6,5 h.30mm (product code 8420.15.030, lot number 1801293, sterilization (b)(4)) new components were implanted.The glenoid anatomy was reconstructed with a new limacorporate 510(k) cleared baseplate and peg.Moreover, 44mm diameter smr reverse hp shoulder components and two new humeral extensions were implanted.Patient is a male, date of birth (b)(6) 1959.This is the second revision surgery for patient's left shoulder.History of surgeries as follows: - implant of competitor's prosthesis (date unknown).- first revision surgery performed on (b)(6) 2018, during which the lima smr reverse shoulder was implanted.Reason for revision not known - second revision surgery performed on (b)(6) 2021, due to dislocation and loosening of the glenoid components (herein reported).Patient's right shoulder was revised on (b)(6) 2019, due to loosening of the glenoid component.The revision was registered as complaint #060_21 and reported to the fda by mfr #3008021110-2021-00020.Event happened in the united states.

• Brand Name: SMR GLENOSPHERE Ø40MM
• Type of Device: GLENOSPHERE
• Manufacturer (Section D): LIMACORPORATE S.P.A.; via nazionale 52; villanova di san daniele, udine 33038 ; IT 33038
• Manufacturer Contact: via nazionale 52; villanova di san daniele, udine 33038
• MDR Report Key: 13169036
• MDR Text Key: 288796473
• Report Number: 3008021110-2021-00109
• Device Sequence Number: 1
• Product Code: PHX
• Combination Product (y/n): N
• PMA/PMN Number: K142139
• 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: 03/28/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/05/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Model Number: 1374.09.120
• Device Lot Number: 1614751
• 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