MAUDE Adverse Event Report: LIMACORPORATE S.P.A. SMR TRAUMA HUMERAL BODY # MEDIUM; TRAUMA HUMERAL BODIES WITH LOCKING SCREW MEDIUM

Model Number 1350.15.010

Device Problem Detachment of Device or Device Component (2907)

Patient Problem Arthralgia (2355)

Event Date 03/12/2024

Event Type  Injury  

Manufacturer Narrative

Checking the manufacturing charts of involved lots #2307200 and #2320879, no pre-existing anomalies were found on the (b)(4) manufactured with those lot #s respectively.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 anatomic hemi implant performed on (b)(6) 2024, due to dissociation between the smr trauma humeral body # medium (product code 1350.15.010, lot #2307200 - ster.(b)(4)) and the smr cementless finned stem (product code 1304.15.150, lot #2320879 - ster.(b)(4)).No traumatic event was reported.According to the received information, the patient experienced ongoing pain post-operatively of the previous surgery, and when scanned it was evident that the implant had come apart.Surgeon believes that the safety screw must not have been adequately engaged during the primary case.During surgery the surgeon noted that the screw was not engaged, and it was sitting loosely in the humeral body.All primary implants were explanted: · smr cementless finned stem (product code 1304.15.150, lot #2320879 - ster.(b)(4)).· smr trauma humeral body # medium (product code 1350.15.010, lot #2307200 - ster.(b)(4)).· neutral adaptor taper standard (product code 1330.15.270, lot #2320373 - ster.(b)(4)).· smr humeral head ø44 mm (product code 1322.09.440, lot #2312054 - ster.(b)(4)) the humeral canal was reamed, and the new prostheses was implanted.Surgeon took extra care to tighten the safety screw to ensure that the morse taper engaged.Previous surgery took place on (b)(6) 2024.No patient's clinical details are known.Event happened in new zealand.

• Brand Name: SMR TRAUMA HUMERAL BODY # MEDIUM
• Type of Device: TRAUMA HUMERAL BODIES WITH LOCKING SCREW MEDIUM
• Manufacturer (Section D): LIMACORPORATE S.P.A.; via nazionale 52; villanova di san daniele, udine 33038 ; IT 33038
• MDR Report Key: 19170882
• MDR Text Key: 340899719
• Report Number: 3008021110-2024-00035
• Device Sequence Number: 1
• Product Code: KWT
• Combination Product (y/n): N
• 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
• Report Date: 04/23/2024

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: 1350.15.010
• Device Lot Number: 2307200
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 04/24/2024
• 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): Other