MAUDE Adverse Event Report: LIMACORPORATE S.P.A. SMR CEMENTLESS FINNED STEM; FINNED HUMERAL STEMS - 80MM (TI6AL4V) DIA.15MM

Model Number 1304.15.150

Device Problem Inadequacy of Device Shape and/or Size (1583)

Patient Problem Joint Dislocation (2374)

Event Date 03/27/2020

Event Type  Injury  

Manufacturer Narrative

Dhr check: by the check of the dhrs, no pre-existing anomaly was found on the 35 stems placed on the market with lot 1816010.Moreover, this is the first and only complaint received on lot# 1816010, on a total of at least 32 stems with the same lot# already implanted.Explants analysis: explanted components are not available to be returned to lima corporate for analysis.Xrays analysis: the following x-rays were received and analyzed by our medical expert: x-rays dated (b)(6) 2020; x-rays dated (b)(6) 2020.His comments as per follows: "i presume the images are all pre-revision.The index procedure occurred 5 and a half weeks prior to the revision.The position of the implants appear satisfactory.If i were to be hyper-critical one might argue the glenoid baseplate ideally might have been sited 2-3 mm more inferior.That said there is no obvious evidence of impingement seen but i suspect it could happen and it was early days.The tuberosities are not easily seen but i suspect there is functioning cuff anteriorly and posteriorly.If there is functioning anterior and posterior rotator cuff present then 20 degrees humeral retroversion is a good choice.If not, (functioning cuff present) neutral position is appropriate.The surgeon has chosen a lateralised liner which suggests there may have been concern about the stability at the index procedure? i think the surgeon has been harsh on their self in the choice of a 15 mm stem.It looks an appropriate size on these xrays.There has not been much opportunity for osseous integration of the stem, the patient is female and there is still the potential for a twisting torque on the stem during separation of the body from stem.Whatever the cause the stem was identified as loose and appropriately up-sized.In summary: it is speculation but the choice of the lateralised liner at the index procedure is significant.There isn't obvious impingement present but i think that may be a possibility in regards to the cause of the instability." conclusion: according to our analysis, this event cannot be classified as product-related.The stem with lot# 1816010 was in fact manufactured up to specifications, no deviation detected by the check of the production documents.Based on the information received, the cause of the dislocation was related to the shift of the humeral stem into the humeral canal.Thus, during revision surgery, the stem was upsized.The surgeon responsible for both the revision and the primary surgery, believes that the shift of the stem was caused by a suboptimal choice of the component size.Our medical consultant confirmed that the stem might had loosened, , but he commented that the size seems appropriate and speculated that impingement could have contributed to the shoulder instability.In conclusion, we cannot go back with certainty to the root cause of the joint dislocation, but according to the surgeon responsible, it seems to be related to a surgical-factor (suboptimal size of stem implanted).Pms data: according to our pms data, the smr reverse revision rate due to dislocation is 0.14%.Focusing on the stems with codes 1304.15.140÷240 and considering the total number of these stems sold ww, we can estimate a very low specific revision rate due to stem loosening: 0.01%.No specific action for this case.Lima corporate will continue monitoring the market to promptly detect any further similar event.Note: this report is an initial-final combined mdr as all the information available has already been collected and analyzed.

Event Description

Smr reverse revision surgery due to dislocation occurred on (b)(6) 2020.Previous surgery took place on (b)(6) 2020.According to surgeon's comments, the stem (code 1304.15.150, lot# 1816010) was slightly undersized causing the shift of the humeral components and thus the anterior dislocation.Only the humeral side of the implant was replaced.Complaint source reported that the initial plan was to upsize the liner and potentially alter the humeral version to a more neutral position to reduce the risk of the anterior dislocation.However, after removing the liner, the surgeon noticed the entire humeral construct was shifting in the humeral canal.Upon closer examination of the immediate post op xrays from the original surgery, the stem appeared to be slightly undersized.The surgeon decided to implant a 17mm stem and was satisfied with the final stability of the joint.Patient data: (b)(6) years old, female event happened in (b)(6).

• Brand Name: SMR CEMENTLESS FINNED STEM
• Type of Device: FINNED HUMERAL STEMS - 80MM (TI6AL4V) DIA.15MM
• Manufacturer (Section D): LIMACORPORATE S.P.A.; via nazionale 52; villanova di san daniele, udine 33038 ; IT 33038
• MDR Report Key: 9933141
• MDR Text Key: 198023171
• Report Number: 3008021110-2020-00020
• 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
• Type of Report: Initial
• Report Date: 04/07/2020

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 Operator: No Information
• Device Model Number: 1304.15.150
• Device Lot Number: 1816010
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 04/07/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention