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

Model Number 1375.15.610

Device Problems Patient-Device Incompatibility (2682); Appropriate Term/Code Not Available (3191)

Patient Problem Pain (1994)

Event Date 12/18/2020

Event Type  Injury  

Manufacturer Narrative

By the check of the dhrs, no pre-existing anomaly was detected on the components placed on the market with the involved lot#s (1913112, 1703026, 1814979, 1613247).This is the first and only complaint received on the same lot #s.We will submit the final mdr as soon as the investigation will be completed.

Event Description

Shoulder revision surgery due to pain performed on the (b)(6) 2020.Previous surgery took place on the (b)(6) 2020.According to the information received, the surgeon removed the poly liner and commented that the whole construct was moving and the superior screw was not contained in the bone.The following components were removed: baseplate, product code 1375.15.610, lot# 1913112; peg, product code 1375.14.661, lot# 1703026; liner, product code 1377.50.010, lot unknown; screw, product code 8420.15.060, lot# 1814979; screw, product code 8420.15.030, lot# 1613247.A baseplate with a longer peg was then implanted.Cement was used to remedy the bone defect.The humeral head (from a different manufacturer) was initially removed and then re-implanted.The surgeon commented that a longer peg may have been implanted during previous surgery, but at that time he was satisfied of the outcome with the chosen components.Event occurred in (b)(6).

Event Description

Shoulder revision surgery of an smr anatomic prosthesis due to pain performed on the (b)(6) 2020.Previous surgery (revision surgery of a lima competitor's prosthesis) took place on the 16th of june 2020.According to the information received, surgeon (responsible for both the surgeries) removed the poly liner and commented that the whole construct was moving, and the superior screw was not contained in the bone.The following components were removed: smr glenoid peg tt s/std/l #s (product code 1375.14.661, lot# 1703026 - ster.1700132), smr glenoid baseplate standard (product code 1375.15.610, lot# 1913112 - ster.1900359), bone screw ø6,5 h.30mm (product code 8420.15.030, lot# 1613247 - ster.1600280), bone screw ø6,5 h.45mm (product code 8420.15.060, lot# 1814979 - ster.1800336), liner (product code 1377.50.010, lot #19at1kw - ster.1900360).A baseplate with a longer peg was then implanted.Cement was used to remedy the bone defect.The humeral head (from a different manufacturer) was initially removed and then re-implanted.The surgeon commented that a longer peg may have been implanted during previous surgery, but at that time he was satisfied of the outcome with the chosen components.According to the reported information, surgeon indicated the superior screw as the possible cause for patient's pain.Patient is a female, moderately active, born in 1966.Event occurred in australia.

Manufacturer Narrative

By checking the manufacturing charts of the involved lot #s, no pre-existing anomaly was found on the pieces placed on the market with those lot #s.According to our records, at least 46 out of 57 glenoid pegs with lot# 1703026 - ster.1700132 have been implanted and this is the only complaint received on this lot #.According to our records, at least 21 out of 30 glenoid baseplates with lot# 1913112 - ster.1900359 have been implanted and this is the only complaint received on this lot #.According to our records, at least 105 out of 200 bone screws with lot# 1613247 - ster.1600280 have been implanted and this is the only complaint received on this lot #.According to our records, at least 97 out of 200 bone screws with lot# 1814979 - ster.1800336 have been implanted and this is the only complaint received on this lot #.According to our records, at least 59 out of 97 liners with lot #19at1kw - ster.1900360 have been implanted and this is the only complaint received on this lot #.Explants were not available to be returned to limacorporate for further analysis.Limacorporate received some pictures of the explants and a total of two x-rays plus one ct scan referring to pre-op revision surgery.The x-rays received - dated 19/11/2020 - have been evaluated by a medical consultant.Following, the medical consultant comments: "the humeral metaphysis shows severe osteolysis, as well as the glenoid component, as far as i can see.This is very much suspicious for a low grade infection, that causes bone resorption.Therefore, it would be no wonder that the screws for the glenoid baseplate do not fit very well as they are expected to do.In conclusion the reason for revision is likely a bone resorption, maybe due to low-grade infection and not implant-related".Stating that: · the check of the manufacturing charts highlighted no anomalies on the components manufactured with lot #s 1703026, 1913112, 1613247, 1814979 and 19at1kw; according to the medical expert's assessment "the reason for revision is likely a bone resorption, maybe due to low-grade infection and not implant-related" we can state that the event was not product related.Pms data: according to limacorporate pms data, revision rate of smr anatomic prosthesis due to pain is 0,03%.No corrective action needed.Limacorporate will keep the market monitored to detect any further similar event.Note: this is a final mdr.

• Brand Name: SMR GLENOID BASEPLATE STANDARD
• Type of Device: SMR TT METAL BACK BASEPLATE (TI6AL4V) - STANDARD
• Manufacturer (Section D): LIMACORPORATE S.P.A.; via nazionale 52; villanova di san daniele, udine 33038 ; IT 33038
• MDR Report Key: 11076628
• MDR Text Key: 229691126
• Report Number: 3008021110-2020-00121
• 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
• Type of Report: Initial,Followup
• Report Date: 05/20/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/28/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Device Model Number: 1375.15.610
• Device Catalogue Number: 1375.15.610
• Device Lot Number: 1913112
• Date Manufacturer Received: 12/23/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention