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

Model Number 1352.15.015

Device Problem Device Dislodged or Dislocated (2923)

Patient Problem Implant Pain (4561)

Event Date 10/04/2022

Event Type  Injury  

Event Description

Revision surgery performed on (b)(6) 2022, due to dislocation and implant loosening.The patient had experience of previous fracture.During the revision surgery the following components were explanted: - smr cementl.Rev.Stem ø13 mm (product code: 1308.15.134, lot number: 2009848, sterilization number: 2000223).- reverse #short hum.Body 140° (product code: 1352.15.015, lot number: 2208108, sterilization number: 2200157).- 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: 2212653, sterilization number: 2200165).- smr small-r connector +4 (product code: 1374.15.314, lot number: 2204184, sterilization number: 2200081).On (b)(6) 2022, the patient presented with pain after post op exercises.X-ray showed dislocation and signs of implant loosening.Previous surgery took place on (b)(6) 2022, due to dislocation, registered with the internal complaint: (b)(6) and reported with the mfr 3008021110-2022-00111.The patient was a male, 58 years old.Event happened in united states.

Manufacturer Narrative

The coupling between reverse #short hum.Body 140° with product code: 1352.15.015 and smr reverse liner retentive with product code: 1365.50.821 is off label.The manufacturing charts were checked with the following results: no pre-existing anomaly was found on the 40 smr cementl.Rev.Stem ø13 mm, that belongs to product code: 1308.15.134, lot number: 2009848 and sterilization number: 2000223.No pre-existing anomaly was found on the 42 reverse #short hum.Body 140°, that belongs to product code: 1352.15.015, lot number: 2208108, sterilization number: 2200157.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 37 smr glenosphere ø 40mm, that belongs to product code: 1374.09.121, lot number: 2212653, sterilization number: 2200165.No pre-existing anomaly was found on the 39 smr small-r connector +4, that belongs to product code: 1374.15.314, lot number: 2204184, sterilization number: 2200081.We will submit a final report as soon as the investigation is completed.

Manufacturer Narrative

According to the product label the coupling between reverse #short hum.Body 140° product code 1352.15.015 and smr reverse liner retentive product code 1365.50.821 is off label use.The product label for 1352.15.015 states couple only with 36mm dia.Liners 1360.50.Cxx, 1361.51.0xx, 1360.50.8xx &1361.50.8xx.The manufacturing charts were checked with the following results: no pre-existing anomaly was found on the 40 smr cementl.Rev.Stem ø13 mm, that belongs to product code 1308.15.134, lot number 2009848 and sterilization number 2000223.No pre-existing anomaly was found on the 42 reverse #short hum.Body 140°, that belongs to product code 1352.15.015, lot number 2208108, sterilization number 2200157.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 37 smr glenosphere ø 40mm, that belongs to product code 1374.09.121, lot number 2212653, sterilization number 2200168.No pre-existing anomaly was found on the 39 smr small-r connector +4, that belongs to product code 1374.15.314, lot number 2204184, sterilization number 2200081.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.The coupling between reverse #short hum.Body 140° product code 1352.15.015 and smr reverse liner retentive product code 1365.50.821 is off label use.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.

Event Description

Revision surgery performed on (b)(6), 2022, due to dislocation and implant loosening.The patient had 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 cementl.Rev.Stem ø13 mm (product code 1308.15.134, lot number 2009848, sterilization number 2000223).Reverse #short hum.Body 140° (product code 1352.15.015, lot number 2208108, sterilization number 2200157).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 2212653, sterilization number 2200165).Smr small-r connector +4 (product code 1374.15.314, lot number 2204184, sterilization number 2200081.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.This event was registered as limacorporate complaint (b)(4) and reported to fda as mfr 3008021110-2022-00111.(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).(object of this report) (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)(6), 2022, examination).(b)(6), 2023, revision surgery performed due to patient condition for dislocation of custom-made devise implanted on (b)(6).Corrective custom-made implant was implanted.(patient condition).

• 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: 15780457
• MDR Text Key: 303562487
• Report Number: 3008021110-2022-00110
• 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

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/11/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Model Number: 1352.15.015
• Device Catalogue Number: 1352.15.015
• Device Lot Number: 2208108
• 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
• Patient Age: 58 YR
• Patient Sex: Male
• Patient Weight: 73 KG