MAUDE Adverse Event Report: LIMACORPORATE S.P.A. SMR - GLENOSPHERE EXTRACTOR

Model Number 9013.74.145

Device Problems Break (1069); Difficult to Remove (1528)

Patient Problem Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Date 03/23/2022

Event Type  malfunction  

Manufacturer Narrative

Checking the manufacturing charts of the involved lot #20aq2du, no anomalies were found on the items manufactured with the involved lot #.This is the first and only complaint received on lot #20aq2du.We will submit a final mdr as soon as the investigation will be completed.

Event Description

During a shoulder surgery performed (b)(6) 2022, the small rod of the smr - glenosphere extractor (product code 9013.74.145, lot #20aq2du).Was stuck in baseplate without disengagement of the glenosphere.According to the received information, no extra threading would pop the glenosphere off.According to the complaint source, the instrument was inserted as per surgical technique.It was reported that multiple attempts were made to remove the glenosphere, however it was destroyed to remove it.The surgeon was then able to remove the core of the glenosphere off the connector.Due to the issue, the surgery was extended of over one hour.The number of uses of the instrument is not known, however it was reported that they are not many.The event occurred during a shoulder revision surgery due to infection: the event was registered as complaint # (b)(4) and reported to the fda by mfr 3008021110-2022-00023.Patient is a male, 72 years old.Event happened in australia.

Manufacturer Narrative

Checking the manufacturing charts of the involved lot #20aq2du, no anomalies were found on the items manufactured with the involved lot #.This is the first and only complaint received on lot #20aq2du.Limacorporate received the components involved in the complaint.The analysis is currently ongoing.We will submit a final mdr as soon as the investigation gets completed.

Event Description

During a shoulder surgery performed on (b)(6) 2022 the small rod of the smr - glenosphere extractor (product code 9013.74.145, lot #20aq2du) was stuck in baseplate without disengagement of the glenosphere.According to the received information, no extra threading would pop the glenosphere off.According to the complaint source, the instrument was inserted as per surgical technique.It was reported that multiple attempts were made to remove the glenosphere, however it was destroyed to remove it.The surgeon was then able to remove the core of the glenosphere off the connector.Due to the issue, the surgery was extended of over one hour.The number of uses of the instrument is not known, however it was reported that they are not many.The event occurred during a shoulder revision surgery due to infection: the event was registered as complaint #071_22 and reported to the fda by mfr 3008021110-2022-00023.Patient is a male, 72 years old.Event happened in australia.

Event Description

During a shoulder surgery performed on (b)(6) 2022, the small rod of the smr - glenosphere extractor (product code 9013.74.145, lot #20aq2du) was stuck in the baseplate smr uncemented glenoid # std (product code 1375.20.010, lot #1211758 - ster.1200331; product not marketed in the us), without disengagement of the glenosphere.According to the received information, no extra threading would pop the glenosphere off.According to the complaint source, the instrument was inserted as per surgical technique.It was reported that multiple attempts were made to remove the glenosphere, however it was destroyed to remove it.The surgeon was then able to remove the core of the glenosphere off the connector.It was reported that the original plan was to exchange the glenosphere and the liner.However, due to the intra-operative issue, the surgery was extended of over one hour, the whole glenoid had to be removed, and the prosthesis was converted to hemi.The number of uses of the instrument is not known, however it was reported that they are not many.The event occurred during a shoulder revision surgery due to infection: the event was registered as complaint (b)(4) and reported to the fda by mfr 3008021110-2022-00023.According to the received information, the glenosphere and the smr connector small std (product code 1374.15.310, lot #1904625 - ster.1900108) were implanted on the baseplate during the previous surgery (it was a revision surgery performed on august 6th, 2019, due to cuff failure, no further details are available on it).Patient is a male, 72 years old.Event happened in australia.

Manufacturer Narrative

By checking the manufacturing charts of the involved lot #20aq2du, no pre-existing anomaly was found on a total of (b)(4) items manufactured with the same lot#.This is the first and only complaint received on lot #20aq2du.Device analysis.Limacorporate received the components involved in the complaint for further analysis.Visual inspection on the returned devices confirmed that the body of the small rod of the glenosphere extractor was bent.The rod was stuck on the connector and baseplate and couldn't be removed.In addition, signs of wear were seen on the instrument's rod, on the tip of the instrument's body and on the instrument's connection, suggesting that several attempts were made with force to disengage the instrument.By disassembling the rod from the components, it was confirmed that the tip of the rod was bent too, hampering the extraction of the piece from the baseplate.Further observation on connector's and baseplate's surfaces performed by a microscopy did not highlight damages related to fretting phenomenon on the surfaces between the two components.Based on the received information we cannot go back with certainty to the root cause of the event.Further checks of the manufacturing charts of the involved baseplate smr uncemented glenoid # std (product code 1375.20.010, lot #1211758 - ster.1200331; product not marketed in the us) and smr connector small std (product code 1374.15.310, lot #1904625 - ster.1900108) confirmed that no dimensional anomalies were found on the parts that couple to each other.Considering that: check of the manufacturing charts highlighted no pre-existing anomalies on the total number of components manufactured with lot #20aq2du; visual inspection on the returned devices confirmed that the rod of the glenosphere extractor was bent, causing it to be stuck on the connector and baseplate; microscopy analysis performed on the connector and baseplate surfaces confirmed the absence of fretting between the two components; no definitive conclusion can be determined on the causes of the instrument malfunctioning.The several attempts made to remove the connector have led to bending of the rod of the glenosphere extractor, and consequently caused the impossibility of the instrument to work for components removal.Pms data: according to our pms data, we can estimate the occurrence rate of malfunctioning of the instrument smr - glenosphere extractor (product code 9013.74.145) to be 0.22% (ww).Please note that this occurrence rate is overestimated because it does not consider the reuse of the instruments but only the total number of pieces manufactured.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 issue.Note: this is a final mdr.

• Brand Name: SMR - GLENOSPHERE EXTRACTOR
• Type of Device: GLENOSPHERE EXTRACTOR
• Manufacturer (Section D): LIMACORPORATE S.P.A.; via nazionale 52; villanova di san daniele, udine 33038 ; IT 33038
• MDR Report Key: 14049915
• MDR Text Key: 298570843
• Report Number: 3008021110-2022-00026
• Device Sequence Number: 1
• Product Code: KWS
• Combination Product (y/n): N
• PMA/PMN Number: K110598
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 10/05/2022

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: 9013.74.145
• Device Lot Number: 20AQ2DU
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 04/08/2022
• Supplement Dates Manufacturer Received: Not provided; Not provided
• Supplement Dates FDA Received: 08/29/2022; 10/21/2022
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Outcome(s): Other