MAUDE Adverse Event Report: LIMACORPORATE S.P.A. SMR CEMENTLESS FINNED STEM; FINNED HUMERAL STEMS - 80MM (TI6AL4V) DIA.20MM

Model Number 1304.15.200

Device Problem Manufacturing, Packaging or Shipping Problem (2975)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 09/27/2022

Event Type  malfunction  

Event Description

Intra-operative issue occurred on the (b)(6) of (b)(6) 2022 during shoulder surgery: the packaging of the smr cementless finned stem with product code 1304.15.200, lot 1810263, ster.1800254, was found damaged.Another stem (cemented stem 1306.15.200) was therefore implanted and the surgery was positively completed with few minutes of delay.This event occurred in france.

Manufacturer Narrative

By the check of the device history records, no pre-existing anomaly was detected on the stems released with lot number 1810263, ster.1800254.This is the first and only complaint received on lot number 1810263.We will submit a final report after the conclusion of the investigation.

Manufacturer Narrative

By the check of the device history records, no pre-existing anomaly was detected on the stems released with lot number 1810263, ster.(b)(4).This is the first and only complaint received on lot number 1810263.Following the visual inspection of the retrieved packaging, the type of damages observed makes us believe that they could be related to an incorrect handling of the device and/or as a consequence of a fall or impact: it is very unlikely that these damages may have occurred during standard transport/storage.Stating that: - by the check of the production documents, no pre-existing anomalies were identified - limacorporate is not aware of any other complaint on the same production or sterilization lot numbers - the damages observed suggest they may have been caused by mishandling of the device we conclude that the packaging issue reported is probably related to external factors such as incorrect handling of the item.We would like to specify that the indications provided by the manufacturer, reported on the packaging, on the instruction for use and on the envelopes themselves, clearly specify that the device must not be used if the package is damaged or the vacuum on the envelopes is no longer present: in case of broken packages, the item must not be used on a patient.Based on limacorporate pms data and considering the smr stems with codes from 1304.15.Xxx, packaged with the most recent version of the packaging (i.E.Internal pa pouch + 2 vacuumed pouches + boxes with protective sponges, introduced in 2016), we can estimate an occurrence rate of this kind of intra-operative issue of about 0.01%.

Event Description

Intra-operative issue occurred on the (b)(6) 2022 during shoulder surgery: the packaging of the smr cementless finned stem with product code 1304.15.200, lot 1810263, ster.(b)(4), was found damaged.Another stem (cemented stem (b)(4)) was therefore implanted, and the surgery was positively completed with few minutes of delay.This event occurred in france.

• Brand Name: SMR CEMENTLESS FINNED STEM
• Type of Device: FINNED HUMERAL STEMS - 80MM (TI6AL4V) DIA.20MM
• Manufacturer (Section D): LIMACORPORATE S.P.A.; via naizonale 52; villanova di san daniele, udine 33038 ; IT 33038
• Manufacturer Contact: via nazionale 52; villanova di san daniele, udine 33038
• MDR Report Key: 15649328
• MDR Text Key: 306652804
• Report Number: 3008021110-2022-00098
• Device Sequence Number: 1
• Product Code: HSD
• Combination Product (y/n): N
• PMA/PMN Number: K101263
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other
• Reporter Occupation: Other
• Type of Report: Initial,Followup

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/21/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Model Number: 1304.15.200
• Device Lot Number: 1810263
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 09/28/2022
• 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): Hospitalization