MAUDE Adverse Event Report: LIMACORPORATE SPA; SMR CEMENTED STEM Ø16 MM

Model Number 1306.15.160

Device Problem Patient Device Interaction Problem (4001)

Patient Problems Loss of Range of Motion (2032); Implant Pain (4561)

Event Type  Injury  

Event Description

Shoulder revision surgery due to pain and radiological loosening of revision shoulder replacement.Revision surgery date is (b)(6) 2021.The following devices were explanted during the revision surgery: smr cemented stem ø16 mm code 130615160, lot 1601346.Smr reverse humeral body short code 135215005, lot 1704554.Smr reverse liner standard code 136050010, lot 17at1nz.Smr glenosphere ø36mm small-r code137409105, lot 1713817.Smr glenoid peg tt small-r #xl code 137514654, lot 1712226.Smr glenoid baseplate small-r, code 137515650, lot 1712220.Bone screw ø6,5 h.40mm code 842015050, lot 1711901.Based on the available information, the patient had a previous revision surgery due to infection and a further revision surgery on (b)(6) 2018, when lima devices were implanted.It was also reported that the patient experienced increased pain around the lateral aspect of the shoulder and decreased range of movement.In 2019 the infection recurred and was treated with antibiotics and open biopsy.The last revision surgery (object of this report, first revision surgery of lima devices) was then performed in 2021.Event occurred in the united kingdom.Note: among the listed devices, only the following prodcut codes are marketed in the usa: 130615160, 135215005, 137409105, 137514654, 842015050.

Manufacturer Narrative

By the check of the device history records, no pre-existing anomaly that could have contributed to the reported complaint was detected on the devices released with the lot numbers involved.We will submit a final report after the final investigation.

• Type of Device: SMR CEMENTED STEM Ø16 MM
• Manufacturer (Section D): LIMACORPORATE SPA; 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: 16945188
• MDR Text Key: 315367309
• Report Number: 3008021110-2023-00051
• 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: Health Professional
• Reporter Occupation: Other
• Type of Report: Initial

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/17/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Model Number: 1306.15.160
• Device Lot Number: 1601346
• 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