MAUDE Adverse Event Report: LIMACORPORATE S.P.A REVERSE #SHORT HUM. BODY 140°

Model Number 1352.15.005

Device Problem Device Dislodged or Dislocated (2923)

Patient Problem Failure of Implant (1924)

Event Date 08/11/2022

Event Type  Injury  

Manufacturer Narrative

The manufacturing charts were checked with the following results: no pre-existing anomaly was found on the 54 smr reverse humeral body short, that belongs to product code 1352.15.005, lot number 2202693, sterilization number 2200086.No pre-existing anomaly was found on the 58 smr reverse liner retentive, that belongs to product code 1365.50.821, lot number 20at18x, sterilization number 2000398.No pre-existing anomaly was found on the 36 smr glenosphere ø 40mm, that belongs to product code 1374.09.121, lot number 2209498, sterilization number 2200131.No pre-existing anomaly was found on the 50 smr connector small r, that belongs to product code 1374.15.305, lot number 2211126, sterilization number 2200140.We will submit a final report as soon as the investigation is completed.

Event Description

Revision surgery performed on (b)(6) 2022, due to dislocation.The patient had experience of previous fracture.On (b)(6) 2022, the patient presented with dislocation and open reduction planned.During the revision surgery the following components were explanted: smr reverse humeral body short (product code 1352.15.005, lot number 2202693, sterilization number 2200086).Smr reverse liner retentive (product code 1365.50.821, lot number 20at18x, sterilization number 2000398).Smr glenosphere ø 40mm (product code 1374.09.121, lot number 2209498, sterilization number 2200131).Smr connector small r (product code 1374.15.305, lot number 2211126, sterilization number 2200140).During the revision surgery, open reduction with replacement of glenosphere, connector and screw with fracture repair were completed successfully.The previous surgery took place on (b)(6) 2022.The following revision surgery took place on (b)(6) 2022, due to dislocation and implant loosening, registered with the internal complaint 286/22 and reported with the mfr 3008021110-2022-00110.The patient was a male, 58 years old.Event happened in united states.

Event Description

Revision surgery performed on (b)(6) 2022, due to dislocation.The patient had experience of previous fracture.During the revision surgery, open reduction with replacement of glenosphere, connector and screw with fracture repair were completed successfully.Experience of previous fracture.Patient - male.Date of birth - (b)(6) 1964.Event happened in united states.During the revision surgery the following components were explanted: - smr reverse humeral body short (product code 1352.15.005, lot number 2202693, sterilization number (b)(4)) - smr reverse liner retentive (product code 1365.50.821, lot number 20at18x, sterilization number b)(4)) - smr glenosphere ø 40mm (product code 1374.09.121, lot number 2209498, sterilization number b)(4)) - smr connector small r (product code 1374.15.305, lot number 2211126, sterilization number b)(4)) according to the complaint source, patient has a very complicated clinical history: (b)(6) 2022, revision surgery performed for dislocation.Surgeon stated very difficult surgery due to patient condition.(b)(6) 2022, patient presented with dislocation and open reduction was planned.(b)(6) 2022, revision surgery performed for dislocation.The open reduction with fracture repair was completed successfully.(object of this report) (b)(6) 2022, revision surgery performed for dislocation/loosening.During the revision surgeon commented he opted for a standard glenosphere to be implanted but the ideal component to be implanted would have been a compassionate use device component.(hp reverse glenosphere).This event was registered as limacorporate complaint (b)(6) and reported to fda as mfr 3008021110-2022-00110.(b)(6) 2022, follow up visit the patient presented with a dislocation and pain.Revision surgery is planned for a later date.This event was registered as limacorporate complaint (b)(4) and reported to fda as mfr 3008021110-2022-00139.(b)(6) 2023, a compassionate use custom made shoulder implant surgery was performed.(per request from b)(46 2022, examination) (b)(6) 2023, revision surgery performed due to patient condition for dislocation of custom-made device implanted on (b)(6).Corrective custom-made implant was implanted.(patient condition).

Manufacturer Narrative

The manufacturing charts were checked with the following results: - no pre-existing anomaly was found on the 54 smr reverse humeral body short, that belongs to product code 1352.15.005, lot number 2202693, sterilization number (b)(4).- no pre-existing anomaly was found on the 58 smr reverse liner retentive, that belongs to product code 1365.50.821, lot number 20at18x, sterilization number (b)(4).- no pre-existing anomaly was found on the 36 smr glenosphere ø 40mm, that belongs to product code 1374.09.121, lot number 2209498, sterilization number (b)(4).- no pre-existing anomaly was found on the 50 smr connector small r, that belongs to product code 1374.15.305, lot number 2211126, sterilization number (b)(4).X-rays analysis.Unfortunately, the components explanted were not available to be returned to limacorporate.However, we received the x-rays taken on (b)(6) 2022.The x rays along with complaint data were evaluated by a medical expert.Results were : radiographs (b)(6) show a superiorly tilted baseplate and subsequently glenosphere; long stemmed humeral component is proud, the major tubercle detached from the metaphysis.Radiographs (b)(6) show a fixed major tubercle, but still proud humeral metaphysis and a lot distalisation and medialisation which can be a factor for mech.Impingement, subsequent leverage and finally dislocation.(b)(6) : still bone fragments of the major tubercle postero-medial as a sign for improper rc refixation with the bone to the metaphysis.Final radiographs do not look good, osteolytic areas around the stem, major tubercle not well integrated.Overall a mix of surgical and disease issues here.I do not see any implant-related problems here.Based on the information received, we are not able to further investigate the root cause of the event.However, considering that; · the check of the manufacturing charts highlighted no anomalies on the components manufactured with the involved lot #s, · the results of medical evaluation by expert stated overall a mix of surgical and disease issues here.Do not see any implant-related problems here.We can conclude that the event was not product related.Pms data according to our pms data, we can estimate the revision rate of smr reverse rev hum bodies commercial codes 1352.15.0xx + 1352.20.Xxx for dislocation is 0.02% reverse liners, commercials codes 1360.50.Xxx + 1361.50.Xxx + 1365.50.Xxx for loosening/dislocation is 0.06% 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 the final mdr.

• Brand Name: REVERSE #SHORT HUM. BODY 140°
• Type of Device: REVERSE #SHORT HUM. BODY 140°
• 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: 15780464
• MDR Text Key: 303557030
• Report Number: 3008021110-2022-00111
• Device Sequence Number: 1
• Product Code: MBF
• Combination Product (y/n): N
• PMA/PMN Number: K201905
• 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: 02/09/2022
• 2 Devices were Involved in the Event: 1 2

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Model Number: 1352.15.005
• Device Lot Number: 2202693
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 11/11/2022
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 02/15/2024
• 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
• Patient Age: 58 YR
• Patient Sex: Male
• Patient Weight: 73 KG