MAUDE Adverse Event Report: LIMACORPORATE SPA SMR-R CTA RESURF. STEM 13X36MM; SMR-R CTA RESURF. STEM 13X36MM (HSD-KWS)

Model Number 1317.15.020

Device Problem Material Erosion (1214)

Patient Problems Failure of Implant (1924); Pain (1994)

Event Date 01/07/2020

Event Type  Injury  

Manufacturer Narrative

Check of the dhr: by checking the manufacturing charts of the involved lot#s, no pre-existing anomaly was detected.This is the first and only complaint received on these lot #s.Explant and xrays analysis: not available for analysis.Based on the few information received, we cannot identify the root cause of the event.However, stating that: no further complaints were received on these lot #s.Primary surgery was performed more than 4 years before revision.No pre-existing anomaly were detected.Surgeon hypothesized that possible cause for pain was slight erosion of the rotator cuff.We judged this case as not product related.Pms data: according to our pms data, we are aware of only 3 cases of revision of smr resurfacing system due to pain on more than (b)(4) smr resurfacing system implanted since 2006, giving an occurence rate of (b)(4)%.No corrective action implemented for this specific case.Limacorporate will keep the market monitored.Please, consider this mdr as a final report.

Event Description

Revision surgery performed on (b)(6) 2020 due to pain.Primary surgery was performed on (b)(6) 2015.During revision, resurfacing head (not registered in usa) and stem code 1317.15.020 lot#1501404 were replaced with smr anatomic system.According to the information reported, surgeon was unsure of reason for pain, but possibly it was due to slight erosion of the rotator cuff.However there was sufficient cuff to convert to anatomic as opposed to a reverse.Patient was fairly fit and active (b)(6) year old male.Event occurred in (b)(6).

• Brand Name: SMR-R CTA RESURF. STEM 13X36MM
• Type of Device: SMR-R CTA RESURF. STEM 13X36MM (HSD-KWS)
• Manufacturer (Section D): LIMACORPORATE SPA; via nazionale 52; villanova di san daniele, udine 33038 ; IT 33038
• Manufacturer (Section G): LIMACORPORATE SPA; via nazionale 52; villanova di san daniele, udine 33038 ; IT 33038
• Manufacturer Contact: federica malvaso ; via nazionale 52; villanova di san daniele, udine 33038 ; IT 33038
• MDR Report Key: 9611204
• MDR Text Key: 189497463
• Report Number: 3008021110-2020-00001
• Device Sequence Number: 1
• Product Code: HSD
• Combination Product (y/n): N
• PMA/PMN Number: K112900
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: other
• Type of Report: Initial
• Report Date: 01/21/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/21/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Device Model Number: 1317.15.020
• Device Lot Number: 1501404
• Date Manufacturer Received: 01/10/2020
• 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): Required Intervention