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

Model Number 1375.14.653

Device Problems Break (1069); Loose or Intermittent Connection (1371); Appropriate Term/Code Not Available (3191)

Patient Problems Pain (1994); Loss of Range of Motion (2032)

Event Date 03/08/2022

Event Type  Injury  

Event Description

Shoulder revision surgery of a smr reverse prosthesis performed on (b)(6) 2022, due to implant loosening.It was reported that the loosening has occurred due to the bone graft resorbing, therefore the baseplate did not take.According to the complaint source, a bone screw broke, and the implant moved.All glenoid components were removed: smr glenoid peg tt small-r #l (product code 1375.14.653, lot #1918963 - ster.1900428).Smr glenoid baseplate small-r (product code 1375.15.605, lot #2005910 - ster.2000220).Cortical bone screw d.4,5 l.40mm (product code 8431.15.040, lot #1914509 - ster.1900351).Cortical bone screw d.4,5 l.40mm (product code 8431.15.040, lot #1702124 - ster.1800049).Smr reverse hp liner short (product code 1362.09.010, lot #1919045 - ster.2000028) - product not sold in the us.Smr connector small r (product code 1374.15.305, lot #2010327 - ster.2000220).Smr reverse hp glenosphere 44 mm (product code 1374.50.440, lot #2000035 - ster.2000017) - product not sold in the us.A cta head was implanted.Patient's clinical history of shoulder surgeries is the following: primary surgery took place on (b)(6) 2011 (smr anatomic total implanted) first revision surgery performed on (b)(6) 2017, due to pain and loss of rom.Intraoperatively the glenoid metal back was found to be solidly fixed so the surgeon decided to replace only the humeral head and the adaptor taper.The event was registered as complaint #(b)(4) and reported to the fda by mfr 3008021110-2017-00053; second revision surgery performed on (b)(6) 2020, due to implant dislocation and pain.The smr anatomic total was converted to a smr reverse prosthesis.The event was registered as complaint #(b)(4) and reported to the fda by mfr 3008021110-2020-00068.According to the surgeon responsible for this conversion surgery (different from the one responsible for the first revision surgery), the anatomic prosthesis implanted failed for the second time since the glenoid metal back was not rectified during the first revision surgery; third revision surgery performed on (b)(6) 2022, due to implant loosening (hereby reported).Patient is a female, (b)(6).

Manufacturer Narrative

Checking the dhr of the involved lot #s 1918963, 2005910, 1914509 and 1702124, no anomalies were found on the items manufactured with these lot #s.We will submit a final mdr as soon as the investigation will be completed.

Manufacturer Narrative

Checking the manufacturing charts of the involved lot #1918963, no pre-existing anomaly was found on a total of (b)(4) manufactured with the same lot #.According to our records, at least (b)(4) glenoid pegs with lot #1918963 - ster.1900428 have been implanted and this is the only complaint received on this lot #.Checking the manufacturing charts of the involved lot #2005910, no pre-existing anomaly was found on a total of 60 items manufactured with the same lot #.The lot was manufactured up to specifications and in-line with the relevant checks and tests.Checking the manufacturing charts of the involved lot #1914509, no pre-existing anomaly was found on a total of (b)(4) manufactured with the same lot #.According to our records, at least (b)(4) screws with lot #1914509 - ster.1900351 have been implanted and this is the only complaint received on this lot #.Checking the manufacturing charts of the involved lot #1702124 - ster.1800049, no pre-existing anomaly was found on a total of (b)(4) manufactured with lot #1702124 - ster.1800049.The lot was manufactured up to specifications and in-line with the relevant checks and tests.Explants analysis: the items involved were not available to be returned to limacorporate for further analysis.X-rays analysis: limacorporate received a total of two x-rays referring to pre-operative revision surgery.The x-rays received - exact date not known - and some pictures of the explanted items have been evaluated by a medical consultant.Following, the medical consultant comments: "as far as i can see, this is a pretty normal course of events.The first revision probably should have been a conversion to rsa already, but that is speculation in retrospect.The last revision is due to bone resorption of the bone graft, this happens in elderly people quite frequently and we have no information about the reason for it in this specific case.The explants look unremarkable.I cannot see any implant related issues in this case".Considering that: · check of the manufacturing charts highlighted no anomalies on the total number of components manufactured with lot #s 1918963, 2005910, 1914509 and 1702124; · according to the complaint source "the loosening has occurred due to the bone graft resorbing, therefore the baseplate did not take"; · according to the medical consultant "the last revision is due to bone resorption of the bone graft, this happens in elderly people quite frequently" and "the explants look unremarkable.I cannot see any implant related issues in this case"; we can state that the event was patient-factor related.Pms data: according to limacorporate pms data, revision rate of glenoid baseplates - belonging to the family codes 1375.15.Xxx - due to loosening is (b)(4).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 the loosening has occurred due to the bone graft resorbing, therefore the baseplate did not take.According to the complaint source, a bone screw broke, and the implant moved.However, it was reported that it is not possible to identify which of the two screws broke.All glenoid components were removed: · smr glenoid peg tt small-r #l (product code 1375.14.653, lot #1918963 - ster.1900428) · smr glenoid baseplate small-r (product code 1375.15.605, lot #2005910 - ster.2000220) · cortical bone screw d.4,5 l.40mm (product code 8431.15.040, lot #1914509 - ster.1900351) · cortical bone screw d.4,5 l.40mm (product code 8431.15.040, lot #1702124 - ster.1800049) · smr reverse hp liner short (product code 1362.09.010, lot #1919045 - ster.2000028) - product not sold in the us · smr connector small r (product code 1374.15.305, lot #2010327 - ster.2000220) · smr reverse hp glenosphere 44 mm (product code 1374.50.440, lot #2000035 - ster.2000017) - product not sold in the us.A cta head was implanted.Patient's clinical history of shoulder surgeries is the following: · primary surgery took place on (b)(6), 2011 (smr anatomic total implanted); · first revision surgery performed on (b)(6), 2017, due to pain and loss of rom.Intraoperatively the glenoid metal back was found to be solidly fixed so the surgeon decided to replace only the humeral head and the adaptor taper.The event was registered as complaint #(b)(4) and reported to the fda by mfr 3008021110-2017-00053; · second revision surgery performed on (b)(6), 2020, due to implant dislocation and pain.The smr anatomic total was converted to a smr reverse prosthesis.The event was registered as complaint #(b)(4) and reported to the fda by mfr 3008021110-2020-00068.According to the surgeon responsible for this conversion surgery (different from the one responsible for the first revision surgery), the anatomic prosthesis implanted failed for the second time since the glenoid metal back was not rectified during the first revision surgery; · third revision surgery performed on (b)(6), 2022, due to implant loosening (hereby reported).Patient is a female, 74 years old.Event happened in australia.

• Brand Name: SMR GLENOID PEG TT SMALL-R #L
• Type of Device: SMR TT METAL BACK PEG (TI6AL4V) - S-R LONG
• Manufacturer (Section D): LIMACORPORATE S.P.A.; via nazionale 52; villanova di san daniele, udine 33038 ; IT 33038
• MDR Report Key: 13803636
• MDR Text Key: 287525927
• Report Number: 3008021110-2022-00015
• 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: 07/04/2022

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: 1375.14.653
• Device Lot Number: 1918963
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 03/18/2022
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 07/04/2022
• 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): Other