MAUDE Adverse Event Report: LIMACORPORATE SPA SMR CEMENTLESS FINNED STEM; FINNED HUMERAL STEMS - 80MM (TI6AL4V) DIA.19MM

Model Number 1304.15.190

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

Patient Problems Failure of Implant (1924); Pain (1994); Neck Stiffness (2434)

Event Date 05/26/2020

Event Type  Injury  

Manufacturer Narrative

By the check of the dhrs, no pre existing anomaly was found on the stems placed on the market with lot# 1412621.First and only complaint received on the same lot#.We will submit a final mdr as soon as the investigation will be completed.

Event Description

Shoulder revision surgery due to implant loosening performed on (b)(6) 2020, previous surgery (which was also a revision surgery) took place on (b)(6) 2015.During last revision surgery, the anatomical prostheses was revised to a reverse tsr, with the humeral stem (code 130415190, lot# 1412621) replaced with a 16mm long uncemented revision stem.According to the information received, due to the significant resorption of the bone on the lateral cortex, the humeral stem has migrated laterally which has resulted in pain and stiffness for the patient.It was also reported that there appeared to be very little bone ongrowth around any of the components and that, due to the largest stem being not quite large enough, a small amount of cement was wrapped around the proximal portion of the reverse body to provide extra support.The surgeon responsible for the last revision surgery (different from surgeon responsible for previous revision) commented that the stem may have been undersized at the time of implantation event happened in (b)(6).

Event Description

Shoulder revision surgery due to humeral stem loosening performed on (b)(6)2020.Primary surgery took place on (b)(6) 2015.During revision surgery, the anatomical prostheses was revised to a reverse tsr, with the humeral stem (code 1304.15.190 lot# 1412621) replaced with a 16mm long uncemented revision stem.According to the information received, due to the significant resorption of the bone on the lateral cortex, the humeral stem has migrated laterally which has resulted in pain and stiffness for the patient.It was also reported that there was very little bone growth around any of the components, indicating that the components were possibly shifting from the time of implantation.The head, humeral body and stem were removed and replaced.A 16mm x 180mm uncemented revision stem was then implanted with a short reverse body and a medium lateralized liner.Due to the largest stem being not quite large enough, a small amount of cement was wrapped around the proximal portion of the reverse body to provide extra support.The surgeon responsible for revision surgery (different from surgeon responsible for primary surgery) commented that the stem may have been undersized at the time of implantation.Patient is male, 72 years old.Event happened in australia.

Manufacturer Narrative

Check of the dhr: by the check of the dhrs, no pre - existing anomaly was found on (b)(4) placed on the market with lot# 1412621.First and only complaint received on this lot# out of (b)(4) already implanted.Explant analysis: explanted components were not returned to limacorporate for investigation.Xrays analysis: we received pre-revision xray images taken on (b)(6) 2020 and shared them with a medical expert for a clinical investigation.Following, his opinion is reported: "patient is a 72 year old male.The first pre-revision x-ray is 5 and half years post index procedure.There is a suture anchor present which may have been inserted during previous rotator cuff surgery or during the index arthroplasty procedure, we don't know.Either way it raises the likelihood that there was rotator cuff damage which may be significant as a cause of the upward migration of the humeral head.The humeral head is a little high and i think too "thin" and this also may have contributed to the upwards failure of the humeral head? what is missing is an immediate index list op x-ray.This would confirm whether the valgus position of the humeral stem was malposition at the index or secondary to the known humeral stem remodelling associated with stemmed prostheses i have never seen remodelling go on to a valgus malposition so i suspect the malposition was associated with the implantation.The post revision x-rays look very satisfactory.In summary i think there has been a combination of rotator cuff failure pre dating or occurring at the time of the index procedure plus malposition of the humerus at the time of the index procedure but without post up x-rays i cannot be sure of that." in conclusion, considering the opinion of the medical expert ("combination of rotator cuff failure pre dating or occurring at the time of the index procedure plus malposition of the humerus at the time of the index procedure"), the lack of similar complaints on the same lot# and the compliance of the manufacturing chart, we can consider this case as due to the combination of surgical error and patient condition.Event not product related.Pms data: based on our pms data, occurrence rate of revision due to loosening of the cementless stem (b)(4).None of these cases was judged as product related.No corrective actions implemented due to this specific case.Limacorporate will keep the market monitored.

• Brand Name: SMR CEMENTLESS FINNED STEM
• Type of Device: FINNED HUMERAL STEMS - 80MM (TI6AL4V) DIA.19MM
• Manufacturer (Section D): LIMACORPORATE SPA; via nazionale 52; villanova di san daniele, udine 33038 ; IT 33038
• MDR Report Key: 10132930
• MDR Text Key: 195075724
• Report Number: 3008021110-2020-00035
• 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,Followup
• Report Date: 10/15/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/09/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Device Model Number: 1304.15.190
• Device Lot Number: 1412621
• Date Manufacturer Received: 06/01/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention