MAUDE Adverse Event Report: LIMACORPORATE S.P.A SMR SHOULDER; GLENOSPHERE DIA. 40MM

Model Number	1374.09.121
Medical Device Problem Code	Unstable (1667)
Health Effect - Clinical Code	Joint Laxity (4526)
Date of Event	07/16/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
Revision surgery was performed on (b)(6) 2024 due to shoulder instability.Patient underwent primary surgery for reverse total shoulder arthroplasty on (b)(6) 2023 with the following assembly: finned stem short dia 19mm (pn 1304.15.019, lot 2302711, sterilization (b)(4)).Reverse humeral body (pn 1352.15.010, lot 2305346, sterilization (b)(4)).Reverse liner std dia40 (pn 1365.50.810, lot 22at2gy, sterilization (b)(4)).Glenoid peg tt small-r #medium (pn 1375.14.652, lot 2300712, sterilization (b)(4)).Tt augmented baseplate 7° s-r dia27mm (pn 1375.15.507, lot 2303113, sterilization (b)(4)).Connector small-r (pn 1374.15.305, lot 2308047, sterilization (b)(4)).Glenosphere dia40 (pn 1374.09.121, lot 2305626, sterilization (b)(4)).After around one year the construct became unstable and the surgeon revised the patient (hereby reported) removing the above-mentioned connector, glenosphere and liner to implant a more lateralized assembly consisting of: lateralized connector +2mm small-r (pn 1374.15.312, lot 2011107, sterilization (b)(4)).Glenosphere dia36mm (pn 1374.09.111, lot 2407091, sterilization (b)(4)).Reverse liner dia36 +3mm (pn 1360.50.815, lot 23at253, sterilization (b)(4)).Further instability was reported again after another year; therefore, the patient underwent second revision surgery (reported with mfr 3008021110-2026-00245) on (b)(6) 2026 when the surgeon decided to remove all pre-existing humeral components and implant a stryker reunion stem with 135° neck angle: humeral lateralization allowed the surgeon to achieve a stable construct.Glenosphere and connector were therefore removed to implant a non-lateralized glenoid reverse construct (connector pn 1374.15.305 and glenosphere dia36 pn 1374.09.111).Surgery was completed as intended.Patient is male, date of birth (b)(6) 1951.The event occurred in the united states.
Additional Manufacturer Narrative
Review of manufacturing records did not identified any pre-existing anomaly or non conformity possibly contributing to reported issue.Complaint database review did not highlight further similar cases on the involved batches, thus excluding a systematic quality issue.The pre-operative x rays from the second revision surgery (mfr 3008021110-2026-00245) has been shared with external medical expert to be evaluated.According to his opinion, the radiographs show some specific problems: there is inferior glenoid notching with formation of a spur indicative for a mechanical problem; the humeral metaphysis shows a double contour at the tuberosity massive, that could be healed fracture or partially displaced greater tuberosity indicative for a surgical problem.Nevertheless, no sign for implant related failure was identified.Patient is more than 80 years old, bone strain can cause problems and therefore the surgeon chose a smaller glenosphere to reduce them, according to medical expert.From follow up communication, complaint source confirmed that patient anatomy, size, and activity likely led to instability of the construct.Therefore, taking into account that: review of dhr did not highlight any pre-existing anomaly.No further events have been reported from the market on the involved lots.Both complaint source and medical experts confirmed a quite complicated patient clinical picture considering also the most recent revision.It is reasonable to assume that the event is most likely related to patient condition with possible contribution of sub-optimal initial choices of construct, rather than an actual product problem.Based on the available pms data, the revision rate of smr glenosphere, belonging to the family product codes 1374/1376.09.Xxx and 1374/1376.15.Xxx due to instability is around 0.03%.According to the investigation carried out, no corrective action is needed for this event.The manufacturer will continue monitoring the market in order to detect any similar event.

• Brand Name: SMR SHOULDER
• Common Device Name: GLENOSPHERE DIA. 40MM
• 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: 25519179
• Report Number: 3008021110-2026-00261
• Device Sequence Number: 10553682
• Product Code: PHX
• UDI-Device Identifier: 08033390123129
• UDI-Public: 8033390123129
• Combination Product (Y/N): N
• PMA/510(K) Number: K163397
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2023
• Device Explanted Year: 2024
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Other
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 06/16/2026

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: 1374.09.121
• Device Lot Number: 2305626
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 06/16/2026
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 73 YR
• Patient Sex: Male