MAUDE Adverse Event Report: LIMACORPORATE S.P.A SMR TRAUMA HUM. BODY # SHORT

Model Number 1350.15.030

Device Problems Adverse Event Without Identified Device or Use Problem (2993); Insufficient Information (3190)

Patient Problem Joint Laxity (4526)

Event Date 03/02/2023

Event Type  Injury  

Manufacturer Narrative

Checking manufacturing records for lot #2206485 and lot #2124629 no pre-existing anomalies found on the components manufactured with these lot #'s.No other complaints reported on the same lot numbers.Will submit final report once the investigation is complete.

Event Description

Shoulder revision surgery was performed on (b)(6) 2023, for a neutral adapter that disassociated from trauma body while patient was moving in rehab.During revision the surgeon noticed that the fracture was still a factor and that more would have been needed to be done in order to account for the issue.Agent reported: due to the fracture the humeral body was placed to the best of the surgeon's ability.The fracture was most likely the issue.Large patient and was a fracture prior to initial surgery.Components explanted.Neutral adaptor taper standard - commercial code # 1330.15.270 lot #2206485 -ster.#2200119.Smr trauma hum.Body # short - commercial code #1350.15.030 - lot #2124629 - ster.#2200010.Initial surgery - (b)(6) 2023.Patient - male.Age - 68.Approx.Height - 1.68m.Weight - 181kg.This event occurred in u.S.

Event Description

Shoulder revision surgery was performed on (b)(6) 2023, for a neutral adapter that disassociated from trauma body while patient was moving in rehab.During revision the surgeon noticed that the fracture was still a factor and that more would have been needed to be done in order to account for the issue.Agent reported: due to the fracture the humeral body was placed to the best of the surgeon's ability.The fracture was most likely the issue.It was also reported a large patient was involved and was a fracture prior to initial surgery.Components explanted.Neutral adaptor taper standard - commercial code # 1330.15.270 lot #2206485 -ster.#2200119.Smr trauma hum.Body # short - commercial code #1350.15.030 - lot #2124629 - ster.#2200010.Initial surgery - (b)(6) 2023.Patient - male.Age - 68.Approx.Height - 1.68m.Weight - 181kg.This event occurred in u.S.

Manufacturer Narrative

Checking manufacturing records for lot #2206485 and lot #2124629 no pre-existing anomalies found on the components manufactured with these lot #'s.No other complaints were reported on the same lot numbers.X-ray analysis.No additional details were available on this post-operative issue, specifically pre-operative or post-operative x-rays related to the revision surgery were requested to the complaint source, however they were not available.Based on the few information received, we are not able to further investigate the root cause of the event.Considering that: check of the manufacturing records highlighted no anomalies on components manufactured with the involved lot #s.It was also reported that a large patient was involved and had a fracture prior to initial surgery.We can state that the event was not product related.Pms data: (b)(4).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 final mdr.

• Brand Name: SMR TRAUMA HUM. BODY # SHORT
• Type of Device: SMR TRAUMA HUM. BODY # SHORT
• 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 ; IT 33038
• MDR Report Key: 16599068
• MDR Text Key: 311932129
• Report Number: 3008021110-2023-00028
• Device Sequence Number: 1
• Product Code: KWT
• Combination Product (y/n): Y
• PMA/PMN Number: K100858
• 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: 06/09/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/23/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Model Number: 1350.15.030
• Device Lot Number: 2124629
• 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: 68 YR
• Patient Sex: Male
• Patient Weight: 181 KG