MAUDE Adverse Event Report: LIMACORPORATE S.P.A SMR HUMERAL HEAD Ø48 MM

Model Number 1322.09.480

Device Problem Patient Device Interaction Problem (4001)

Patient Problem Implant Pain (4561)

Event Date 02/10/2017

Event Type  Injury  

Manufacturer Narrative

Checking the manufacturing charts for sterilization of the involved lot #s, no pre-existing anomalies were found.This is the first and only complaint received on these lot #s.The explanted items involved were not available to be returned to limacorporate for further analysis.No additional details were available on this post-operative issue, preoperative or post-operative x-rays were requested but not available.Based on the very few information received, we are not able to further investigate the root cause of the event.However, considering the facts: checking sterilization on the manufacturing charts of the involved lot #s, no pre-existing anomalies were found.We can state that the event was not product related.Pms analysis according to limacorporate pms data, revision rate of smr anatomic hemi prosthesis due to infection 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 issues.Note: this is a combined initial-final mdr.

Event Description

Description on (b)(6) 2017, shoulder revision surgery 2nd revision to remove all implants due to potential infection - after the second procedure, the patient continued to have pain.It was then decided for a complete explant of the humeral component.He went back to the operating room for removal, irrigation and debridement, and rotator cuff repair on (b)(6) 2017.No gross appearance of infection observed intra operatively.The patient involved has a complex clinical history: (b)(6) 2016 - initial surgery: a lima smr anatomic total prosthesis was implanted.(b)(6) 2016 - 1st revision surgery due to pain and potential allergy to poly or metal (surgeon concern).Conversion from anatomic to hemi prosthesis.This event was registered by limacorporate as complaint (b)(4) with the mfr 3008021110-2023-00089 (b)(6) 2017 - cultures from (b)(6) 2016 reveal p acne so a second revision surgery was performed to remove all implants (humerus part included) due to potential infection.No gross appearance of infection observed intra operatively.This event was registered by limacorporate as complaint (b)(4).Object of this incident report.Patient data: male, date of birth - (b)(6) 1971, approx.Weight - 113kg, disabled.Items explanted: smr cementless finned stem, commercial code 1304.15.160 - lot #1513099 - ster.#1500329.Smr humeral head ø48 mm, commercial code 1322.09.480 - lot #1520571 - ster.#1600098.Smr ecc.Adaptor taper standard, commercial code 1330.15.272 - lot #1608234 - ster.#1600196.

• Brand Name: SMR HUMERAL HEAD Ø48 MM
• Type of Device: SMR HUMERAL HEAD Ø48 MM
• 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: 17448530
• MDR Text Key: 320280719
• Report Number: 3008021110-2023-00090
• 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: 08/02/2023

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: 1322.09.480
• Device Lot Number: 1520571
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 08/03/2023
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 51 YR
• Patient Sex: Male