MAUDE Adverse Event Report: LIMACORPORATE S.P.A. SMR GLENOSPHERE Ø 36MM; GLENOSPHERE DIA. 36 MM

Model Number 1374.09.111

Device Problem Insufficient Information (3190)

Patient Problem Implant Pain (4561)

Event Date 05/11/2023

Event Type  Injury  

Manufacturer Narrative

Checking the manufacturing charts of the involved lots #1501808 and #15at065, no pre-existing anomalies were found on the components manufactured with those lot #s.This is the first and only complaint received on those lot #s.We submit a final mdr as soon as the investigation is complete.

Event Description

Shoulder revision surgery of a smr reverse prosthesis performed on (b)(6) 2023, due to pain and loss of range of motion.The following components got explanted and replaced with same size components: smr glenosphere ø 36mm (product code 1374.09.111, lot #1501808 - ster.1500078).Smr reverse liner standard (product code 1360.50.010, lot #15at065 - ster.1500112) - product not sold in the us; smr connector small r (product code 1374.15.305, lot #1502704 - ster.1500097) previous surgery took place on (b)(6) 2015.It was reported that during it, the cement spacer that was in place was replaced by implanting the smr reverse prosthesis, however no record is available on the history of shoulder surgeries.Patient is a female.She has a low activity level.No further information available.Event happened in australia.

Event Description

Range of motion.It was reported that pain onset started 1-2 years prior to the revision surgery.The following components got explanted and replaced with same size components: · smr glenosphere ø 36mm (product code 1374.09.111, lot #1501808 - ster.1500078) · smr reverse liner standard (product code 1360.50.010, lot #15at065 - ster.1500112) - product not sold in the us; · smr connector small r (product code 1374.15.305, lot #1502704 - ster.1500097) previous surgery took place on (b)(6)2015.It was reported that during it the cement spacer was replaced by implanting the smr reverse prosthesis, however no record is available on the history of patient shoulder surgeries.Patient is a female.She performs low activity level.No further information available.Event happened in australia.

Manufacturer Narrative

Checking the manufacturing charts of the involved lot #1501808, no pre-existing anomaly was found on a total of 12 items manufactured with the same lot #.According to our records, all 12 glenospheres with lot #1501808 - ster.1500078 have been implanted and this is the only complaint received on this lot #.Checking the manufacturing charts of the involved lot #15at065, no pre-existing anomaly was found on a total of 107 items manufactured with the same lot #.According to our records, at least 105 out of 107 reverse liners with lot #15at065 - ster.1500112 have been implanted and this is the only complaint received on this lot #.Device 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 revision surgery.The x-ray received - taken one month prior to the revision surgery - has been evaluated by a medical consultant.Following, the medical consultant comments: "i assume that the reason for the first revision was infection, due to the cement spacer implantation, but this remains speculative.I assume that this time again infection was the reason for revision, because the retrieved components were unremarkable.There is no sign of implant-related problems.In summary, most likely a fateful course of events".Further checking the sterilization charts of the involved lot #s, no pre-existing anomaly was found, ensuring that the components had been properly sterilized before being placed on the market.Considering that: · check of the manufacturing and sterilization charts highlighted no anomalies on the components manufactured with lots #1501808 and #15at065; · according to the medical consultant "i assume that this time again infection was the reason for revision, because the retrieved components were unremarkable.There is no sign of implant-related problems"; we cannot determine with certainty the root cause of the event, still 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 pain is 0.02%.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: SMR GLENOSPHERE Ø 36MM
• Type of Device: GLENOSPHERE DIA. 36 MM
• Manufacturer (Section D): LIMACORPORATE S.P.A.; via nazionale 52; villanova di san daniele, udine 33038 ; IT 33038
• MDR Report Key: 16972127
• MDR Text Key: 315827291
• Report Number: 3008021110-2023-00058
• Device Sequence Number: 1
• Product Code: MBF
• Combination Product (y/n): N
• PMA/PMN Number: K163397
• 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: 08/21/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/22/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Model Number: 1374.09.111
• Device Lot Number: 1501808
• 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