MAUDE Adverse Event Report: LIMACORPORATE S.P.A. SMR GLENOID BASEPLATE SMALL-R; SMR TT METAL BACK BASEPLATE (TI6AL4V) - SMALL R

Model Number 1375.15.605

Device Problem Loosening of Implant Not Related to Bone-Ingrowth (4002)

Event Date 11/28/2022

Event Type  Injury  

Manufacturer Narrative

Checking the manufacturing charts of the involved lots: #2000243 and #2002458, no pre-existing anomaly was found on the components manufactured with the same lot #s.This is the first and only complaint received on these lot #s.We submit a final mdr as soon as the investigation is completed.

Event Description

Shoulder revision surgery of a smr reverse prosthesis performed on (b)(6) 2022, due to implant loosening.It was reported that glenoid components experienced loosening over the previous months.According to the received information the poor bone quality negatively impacted the initial fixation, ultimately resulting in glenoid loosening.Patient did not report pain and was satisfied to leave without surgery, however it progressed until pain and therefore a revision surgery was performed.During surgery all components got explanted: smr glenoid baseplate small-r (product code: 1375.15.605, lot#: 2002458 - ster.2000075), smr glenoid peg tt small-r #l (product code: 1375.14.653, lot#: 2000243 - ster.2000030), smr cementless finned stem (product code: 1304.15.140, lot#: 1907274 - ster.1900232), smr reverse humeral body (product code: 1352.20.010, lot#: 1923058 - ster.2000030), product not sold in the us.Smr reverse hp liner short (product code: 1365.09.010, lot#: 1916072 - ster.1900365), product not sold in the us smr connector small r (product code: 1374.15.305, lot#: 2000448 - ster.2000051), smr reverse hp glenosphere 40 mm (product code: 1374.50.400, lot#: 1921407 - ster.1900453), product not sold in the us.Bone screw ø6,5 h.25mm (product code: 8420.15.020, lot#: 1921147 - ster.2000012), bone screw ø6,5 h.30mm (product code: 8420.15.030, lot#: 1921154 - ster.2000012), a customized glenoid implant was implanted with standard humeral components.Primary surgery took place on (b)(6) 2020.Patient is a female, 82 years old.According to the received information she has a low activity level and moderate bmi.Event happened in australia.

Manufacturer Narrative

Checking the manufacturing charts of the involved lot #2002458, no pre-existing anomaly was found on the components manufactured with the same lot #.According to our records, at least 55 out of 56 glenoid baseplates with lot #2002458 - ster.2000075 have been implanted and this is the only complaint received on this lot #.Checking the manufacturing charts of the involved lot #2000243, no pre-existing anomaly was found on the components manufactured with the same lot #.According to our records, at least 40 out of 64 glenoid pegs with lot #2000243 - ster.2000030 have been implanted and this is the only complaint received on this lot #.Explants analysis the items involved were not available to be returned to limacorporate for further analysis.X-rays analysis limacorporate received one x-ray referring to pre-operative revision surgery.The x-ray received - dated 10/10/2022 - has been evaluated by a medical consultant.Following, the medical consultant comments: "from the radiographs one can only guess about bone quality, the glenoid implant is completely loose and dislocated.Age 82 and female sex are a problem per se, so some sort of reduced bone quality can be assumed.Another factor might come into play: peripheral neuropathy is a common disease among the elderly, often underdiagnosed.The fact that she did not complain about pain and might be a suspicious indicator, but this is speculative.Surgical errors at the primary implantation in terms of unreliable glenoid fixation is very speculative, no signs per se from the information we have.So overall, no clear determination of reasons for failure here, implant related issues can be ruled out".Considering that: · check of the manufacturing charts highlighted no anomalies on the components manufactured with lot #2002458 and #2000243; · according to the received information, the poor bone quality negatively impacted the initial fixation, ultimately resulting in glenoid loosening; · according to the medical consultant "age 82 and female sex are a problem per se, so some sort of reduced bone quality can be assumed.Another factor might come into play: peripheral neuropathy is a common disease among the elderly, often underdiagnosed" and also "surgical errors at the primary implantation in terms of unreliable glenoid fixation is very speculative, no signs per se from the information we have"; we cannot determine the root cause of the event; still we can state that the event was not product related.Pms data: according to limacorporate pms data, revision rate of smr reverse prosthesis due to loosening of the glenoid components is 0.07%.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.

Event Description

Shoulder revision surgery of a smr reverse prosthesis performed on (b)(6) 2022, due to implant loosening.It was reported that glenoid components experienced loosening over the previous months.According to the received information the poor bone quality negatively impacted the initial fixation, ultimately resulting in glenoid loosening.Patient did not report pain and was satisfied to leave without surgery, however it progressed until pain and therefore a revision surgery was performed.During surgery all components got explanted: · smr glenoid baseplate small-r (product code 1375.15.605, lot #2002458 - ster.2000075).· smr glenoid peg tt small-r #l (product code 1375.14.653, lot #2000243 - ster.2000030).· smr cementless finned stem (product code 1304.15.140, lot #1907274 - ster.1900232).· smr reverse humeral body (product code 1352.20.010, lot #1923058 - ster.2000030).- product not sold in the us.· smr reverse hp liner short (product code 1365.09.010, lot #1916072 - ster.1900365).- product not sold in the us.· smr connector small r (product code 1374.15.305, lot #2000448 - ster.2000051).· smr reverse hp glenosphere 40 mm (product code 1374.50.400, lot #1921407 - ster.1900453) - product not sold in the us.· bone screw ø6,5 h.25mm (product code 8420.15.020, lot #1921147 - ster.2000012)· bone screw ø6,5 h.30mm (product code 8420.15.030, lot #1921154 - ster.2000012).A customized glenoid implant was implanted with standard humeral components.Primary surgery took place on (b)(6) 2020.Patient is a female, 82 years old.According to the received information she has a low activity level and moderate bmi.Event happened in australia.

• Brand Name: SMR GLENOID BASEPLATE SMALL-R
• Type of Device: SMR TT METAL BACK BASEPLATE (TI6AL4V) - SMALL R
• Manufacturer (Section D): LIMACORPORATE S.P.A.; via nazionale 52; villanova di san daniele, udine 33038 ; IT 33038
• MDR Report Key: 15924047
• MDR Text Key: 304908475
• Report Number: 3008021110-2022-00125
• Device Sequence Number: 1
• Product Code: KWS
• Combination Product (y/n): N
• PMA/PMN Number: K133349
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 04/03/2023

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: 1375.15.605
• Device Lot Number: 2002458
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 12/06/2022
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 04/06/2023
• 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