MAUDE Adverse Event Report: LIMACORPORATE S.P.A. SMR GLENOID BASEPLATE SMALL; SMR TT METAL BACK BASEPLATE (TI6AL4V) - SMALL

Model Number 1375.15.620

Device Problem Patient Device Interaction Problem (4001)

Patient Problem Inadequate Osseointegration (2646)

Event Date 01/17/2024

Event Type  Injury  

Manufacturer Narrative

Checking the manufacturing charts of involved lots #1811186, no pre-existing anomalies were found on the 30 components manufactured with those lot #s.We submit a final mdr as soon as the investigation is complete.

Event Description

Shoulder revision surgery performed on smr reverse performed on (b)(6) 2024, due to implant loosening.It was reported that the bone graft was insufficient to hold the tt metalback glenoid.The following components were explanted: · smr glenoid baseplate small (product code 1375.15.620, lot #1811186 - (b)(4)) · smr glenoid peg tt s/std #m (product code 1375.14.662, lot #1704235 - (b)(4)) · bone screw ø6,5 h.20mm (product code 8420.15.010, lot #2012100 - (b)(4)) · bone screw ø6,5 h.25mm (product code 8420.15.020, lot #2015483 - (b)(4)) · smr reverse humeral body (product code 1352.20.010, lot #2014060 - (b)(4)) - product not sold in the us · smr reverse hp liner short (product code 1365.09.010, lot #2010243 - (b)(4)) - product not sold in the us · smr connector small std (product code 1374.15.310, lot #1917458 - (b)(4)) · smr reverse hp glenosphere 40 mm (product code 1374.50.400, lot #2017556 - (b)(4)) - product not sold in the us.A customized glenoid (cmd 23-1306) was implanted with very good fixation and coverage.Previous surgery took place on (b)(6), 2020.Patient is a female, 74 years old.Event happened in new zealand.

Manufacturer Narrative

Checking the dhrs of the involved lot #1811186, no pre-existing anomaly was found on the 30 devices manufactured with that lot #.According to our records, at least 15 out of 30 glenoid baseplates with lot #1811186 and ster.1900114 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.No additional details were available on this event, specifically pre-operative x-rays were asked to the complaint source but weren't available.According to the applicable instructions for use, and with regards to bone grafting, it is suggested to inspect the graft once removed to ensure the bone quality is adequate for use with the glenoid bone grafting technique, and that the glenoid bone grafting technique should never be used with poor quality bone, as it may compromise bone healing.Moreover, it is suggested to use a peg size medium, long or x-long for glenoid bone grafting technique to enable a minimum section of the peg into the native bone, proving component stability.Differently, a peg size long or x-long should be used in combination with a 15mm graft.The complaint source confirmed that the bone graft thickness was of 7-10mm.The analysis of the provided ct scan used for the development of the customized glenoid have identified scapular bone loss, a coracoid fracture, the presence of osteophytes and bad bone quality on the anterior and inferior rim of the glenoid surface, and humerus bone resorption.Based on the very few information received, we are not able to further investigate the root cause of the event.However, considering that: · check of manufacturing charts highlighted no anomalies on the components manufactured with the involved lot #1811186; · there was insufficient bone for adequate fixation at the time of previous surgery, and the bone graft was insufficient to hold the tt metalback glenoid; · the condition of patient's glenoid was severely eroded prior to bone grafting; we can state that the event is a combination of patient and surgical factor.The event is not product related.Pms data according to limacorporate pms data, the revision rate of smr reverse due to loosening of the glenoid side is 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 continues monitoring the market to promptly detect any similar issue.Note: this is a final mdr.

Event Description

Shoulder revision surgery of a smr reverse prosthesis performed on (b)(6)2024, due to implant loosening on the glenoid side.It was reported that the bone graft was insufficient to hold the tt metalback glenoid.According to the received information, the surgeon admitted that there was insufficient bone for adequate fixation.The following components were explanted: · smr glenoid baseplate small (product code 1375.15.620, lot #1811186 - ster.1900114) · smr glenoid peg tt s/std #m (product code 1375.14.662, lot #1704235 - ster.1700166) · bone screw ø6,5 h.20mm (product code 8420.15.010, lot #2012100 - ster.2000257) · bone screw ø6,5 h.25mm (product code 8420.15.020, lot #2015483 - ster.2000300) · smr reverse humeral body (product code 1352.20.010, lot #2014060 - ster.2000313) - product not sold in the us · smr reverse hp liner short (product code 1365.09.010, lot #2010243 - ster.2000240) - product not sold in the us · smr connector small std (product code 1374.15.310, lot #1917458 - ster.1900396) · smr reverse hp glenosphere 40 mm (product code 1374.50.400, lot #2017556 - ster.2000307) - product not sold in the us a customized glenoid (cmd 23-1306) was implanted with very good fixation and coverage.Previous surgery took place on (b)(6), 2020.Patient is a female, 74 years old.Her bmi is of 33.It was reported that the condition of patient's glenoid was severely eroded prior to bone grafting.Event happened in new zealand.

• Brand Name: SMR GLENOID BASEPLATE SMALL
• Type of Device: SMR TT METAL BACK BASEPLATE (TI6AL4V) - SMALL
• Manufacturer (Section D): LIMACORPORATE S.P.A.; via nazionale 52; villanova di san daniele, udine 33038 ; IT 33038
• MDR Report Key: 18683528
• MDR Text Key: 335071587
• Report Number: 3008021110-2024-00014
• Device Sequence Number: 1
• Product Code: KWS
• Combination Product (y/n): N
• PMA/PMN Number: K133349
• 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: 02/28/2024

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: 1375.15.620
• Device Lot Number: 1811186
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 02/12/2024
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 03/04/2024
• 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): Other