MAUDE Adverse Event Report: LIMACORPORATE S.P.A. TT AUGMENTED 360 BASEPLATE #S-R 15°; SMR TT AUGMENTED 360 BASEPLATE S-R 15°

Model Number 1375.15.515

Device Problem Loss of Osseointegration (2408)

Patient Problems Failure of Implant (1924); Arthralgia (2355)

Event Date 12/14/2023

Event Type  Injury  

Event Description

Shoulder revision surgery performed on (b)(6) 2023, due to glenoid loosening.The following components were removed: tt augmented 360 baseplate #s-r 15° (product code 1375.15.515, lot #2023578 - ster.2100055).Smr glenoid peg tt small-r #l (product code 1375.14.653, lot #1819262 - ster.1900059).Glenosphere ø 36mm (product code 1374.09.111, lot #2009275 - ster.2000227).Smr connector small r (product code 1374.15.305, lot #2023320 - ster.2100029).Bone screw ø6,5 h.20mm (product code 8420.15.010, lot #2020343 - ster.2000378).Bone screw ø6,5 h.30mm (product code 8420.15.030, lot #2017878 - ster.2000348).Smr reverse liner standard (product code 1360.50.010, lot #20at164 - ster.2000293) - product not sold in the us.The humeral stem and the reverse humeral body remained in situ.A customized glenoid (ref.Cmd 23-1430), a 40mm glenosphere and a 40mm reverse liner were implanted.The history of patient shoulder surgeries is the following: primary surgery performed in 2003 (competitor's implant placed in); first revision surgery on (b)(6) 2021 due to unknown reasons.The smr reverse implant was placed in; second revision surgery on (b)(6) 2023, due to implant loosening (hereby reported).No clinical data are available on the patient.Event happened in new zealand.

Manufacturer Narrative

Checking the manufacturing charts of involved lots #1819262 and # 2023578, no pre-existing anomalies were found on the components manufactured with those lot #s.We submit a final mdr as soon as the investigation is complete.

Manufacturer Narrative

Checking the manufacturing charts of the involved lot #2023578, no pre-existing anomaly was found on a total of 10 devices manufactured with the same lot #.Checking the manufacturing charts of the involved lot #1819262, no pre-existing anomaly was found on a total of 59 devices manufactured with the same lot #.According to our records, at least 48 out of 59 glenoid pegs with lot #1819262 and ster.1900059 have been implanted and this is the only complaint received on this lot #.Device analysis: devices involved were not returned to limacorporate for further analysis.X-rays analysis: limacorporate received a total of one x-ray and one ct scan referring to pre-operative revision surgery.The x-ray received - dated (b)(6) 2022 - and the ct scan received - dated (b)(6) 2023 - have been evaluated by a medical consultant.Following, the medical consultant comments: "the preop last revision radiographs show the axioma peg and the baseplate in an upward rotation of about 30°.I cannot identify a bone canal for the peg in a downward slope which would be expected if the implant was in the right position in the first place and migrated superiorly or broke out.This would be an indicator, that the implant was never put in the right place at all and therefore explain the early failure.It is also possible, that the position was correct in the first place but bone integration did not achieve a level to withstand the upward migration forces of the humerus implant.Both scenarios are not implant-related but either surgical error or fateful course of events".Considering that: check of manufacturing charts highlighted no anomalies on components manufactured with lots #2023578 and #1819262; according to the medical consultant, either "the implant was never put in the right place at all" or "the position was correct in the first place but bone integration did not achieve a level to withstand the upward migration forces of the humerus implant".We cannot 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 due to glenoid loosening is 0.08%.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.

Event Description

Shoulder revision surgery of a smr reverse prosthesis performed on (b)(6), 2023, due to glenoid loosening.The following components were removed: tt augmented 360 baseplate #s-r 15° (product code 1375.15.515, lot #2023578 - ster.2100055).Smr glenoid peg tt small-r #l (product code 1375.14.653, lot #1819262 - ster.1900059).Glenosphere ø 36mm (product code 1374.09.111, lot #2009275 - ster.2000227).Smr connector small r (product code 1374.15.305, lot #2023320 - ster.2100029).Bone screw ø6,5 h.20mm (product code 8420.15.010, lot #2020343 - ster.2000378).Bone screw ø6,5 h.30mm (product code 8420.15.030, lot #2017878 - ster.2000348).Smr reverse liner standard (product code 1360.50.010, lot #20at164 - ster.2000293) - product not sold in the us.The humeral stem and the reverse humeral body remained in situ.A customized glenoid (ref.Cmd 23-1430), a 40mm glenosphere and a 40mm reverse liner were implanted.The history of patient shoulder surgeries is the following: primary surgery performed in 2003 (competitor's implant placed in); first revision surgery on (b)(6), 2021, due to unknown reasons.The smr reverse implant was placed in; second revision surgery on (b)(6), 2023, due to implant loosening (hereby reported).No clinical data are available on the patient.Event happened in new zealand.

• Brand Name: TT AUGMENTED 360 BASEPLATE #S-R 15°
• Type of Device: SMR TT AUGMENTED 360 BASEPLATE S-R 15°
• Manufacturer (Section D): LIMACORPORATE S.P.A.; via nazionale 52; villanova di san daniele, udine 33038 ; IT 33038
• MDR Report Key: 18435070
• MDR Text Key: 331868235
• Report Number: 3008021110-2023-00149
• Device Sequence Number: 1
• Product Code: PHX
• 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: 05/06/2024

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: 1375.15.515
• Device Lot Number: 2023578
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 01/03/2024
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 05/06/2024
• 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