MAUDE Adverse Event Report: LIMACORPORATE S.P.A. SMR CEMENTLESS FINNED STEM; FINNED HUMERAL STEMS - 80MM (TI6AL4V) DIA.22MM

Model Number 1304.15.220

Device Problem Packaging Problem (3007)

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

Event Date 06/01/2023

Event Type  malfunction  

Manufacturer Narrative

No pre-existing anomaly was detected by the check of the device history records of the lot number involved (1817294).This is the first and only complaint received on this lot number.A final report will be submitted after the investigation.

Event Description

Intra operative issue occurred during smr reverse shoulder surgery on (b)(6) 2023: the package of the smr stem (code 1304.15.220, lot 1817294) was found broken, a different stem was then implanted.This event occurred in italy.

Manufacturer Narrative

No pre-existing anomaly was detected by the check of the device history records of the lot number involved (1817294, ster.1900016).According to our records, at least 25 stems with lot 1817294, ster.1900016 were already implanted and this is the first and only complaint registered on this lot number.The affected packaging was not returned to limacorporate, however some pictures where shared by the complaint source.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.(b)(4).No corrective actions needed following this complaint.Limacorporate will continue monitoring the market to promptly detect any further similar event.

Event Description

Intra operative issue occurred during smr reverse shoulder surgery on (b)(6) 2023: the package of the smr stem (code 1304.15.220, lot 1817294 ster.1900016) was found broken.As a consequence, another available stem was implanted and the surgery was prolonged of about 15 minutes.This event occurred in italy.

• Brand Name: SMR CEMENTLESS FINNED STEM
• Type of Device: FINNED HUMERAL STEMS - 80MM (TI6AL4V) DIA.22MM
• 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: 17152366
• MDR Text Key: 317824452
• Report Number: 3008021110-2023-00075
• 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

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Model Number: 1304.15.220
• Device Lot Number: 1817294
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 06/19/2023
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 02/12/2024
• 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): Hospitalization