MAUDE Adverse Event Report: LIMACORPORATE SPA SMR CEMENTLESS FINNED STEM; SMR CEMENTLESS FINNED STEM (HSD-KWT)

Model Number 1304.15.210

Device Problem Protective Measures Problem (3015)

Patient Problem Unspecified Infection (1930)

Event Date 07/16/2018

Event Type  Injury  

Manufacturer Narrative

By checking the sterilization charts of all the products implanted during previous surgery.No anomaly was detected, meaning that all the products used had been correctly sterilized before being placed on the market (stem code 1304.15.210, lot# 1609779; humeral head code 132209460003, lot# 1605920; adaptor taper code 1330.15.274, lot# 1608235; humeral body code 1350.15.110, lot#1600384; glenoid code 1375.20.030, lot# 1515916; liner code 1377.50.030, lot# 15at01b).No other complaints received on these lot#.We will proceed with further investigations and submit a final mdr once concluded.

Event Description

Conversion to smr reverse due to cuff failure, performed on (b)(6) 2018.Previous surgery performed on "(b)(6) 2017." during revision surgery the stem (1304.15.210 lot# 1609779) was found to be infected, it came out easily while disengaging the humeral body (code 1350.15.110 lot# 1600384).Infection was not noted pre operatively.Metal back glenoid was well fixed and thus was not replaced during revision surgery.Surgeon was satisfied after testing final stability.(b)(6).

Event Description

Conversion from smr anatomic to smr reverse due to cuff failure performed on (b)(6) 2018.According to the info reported, during the revision surgery, the cementless stem dia.21mm (1304.15.210 lot# 1609779) - previously implanted on (b)(6) 2017- was found to be infected.A finned stem dia.20mm was implanted during the revision surgery.Metal back glenoid was well fixed and thus not replaced during revision surgery.Surgeon satisfied with the final stability of the implant.

Manufacturer Narrative

We never received confirmation of infection by the specimen analysis nor additional information about past patient's infections history.Check of sterilization charts: by checking the sterilization charts of all the products implanted during the previous surgery of (b)(6) 2017, no anomaly was detected, meaning that the overall number of products involved had been correctly sterilized before being placed on the market (stem code 1304.15.210, lot# 1609779; humeral head code 1322.09.460, lot# 1605920; adaptor taper code 1330.15.274, lot# 1608235; humeral body code 1350.15.110, lot#1600384; metal back glenoid code 1375.20.030, lot# 1515916; liner code 1377.50.030, lot# 15at01b).No other complaints received on these lot#.Explants analysis: no explants available to be returned to limacorporate.According to the info reported, explants were disposed of as per hospital policy.X-rays analysis: we received only one x-ray referring to pre-op conversion (exact date unknown).Following, our medical consultant's comment on the x-ray received: "there is not much information, but i can say the humeral head is too high and possibly wrong size.(fyi, during the previous surgery a dia.46mm humeral head was implanted) the infection obviously is a major complication but cuff failure may have been a feature and related to the improper positioning of the humeral head".Conclusion: according to the few info received and based on the analysis performed, we can surely say that this is not a failure product-related.Cuff failure was probably mainly due to patient's progression pathology but, according to our medical consultant's judgement, a previously poor positioning of the humeral head (combined with improper size of the implant) could have contributed to the event.Pms data: we are aware of a total of 19 cases of infection involving a smr cementless stem belonging to the family 1304.15.Xxx and used in both smr anatomical + reverse configuration on a total of (b)(4) smr cementless stem sold ww from 2002.Very low revision rate ((b)(4)).No corrective actions for this specific case.Limacorporate will continue monitoring the market.

• Brand Name: SMR CEMENTLESS FINNED STEM
• Type of Device: SMR CEMENTLESS FINNED STEM (HSD-KWT)
• Manufacturer (Section D): LIMACORPORATE SPA; via nazionale 52; villanova di san daniele, udine 33038 ; IT 33038
• MDR Report Key: 7717749
• MDR Text Key: 114945429
• Report Number: 3008021110-2018-00058
• 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: 02/21/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/25/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Device Model Number: 1304.15.210
• Device Lot Number: 1609779
• Date Manufacturer Received: 07/20/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention