MAUDE Adverse Event Report: LIMACORPORATE SPA SMR CTA HUMERAL HEAD; SMR CTA HUMERAL HEAD(HSD-KWS )

Model Number 1323.09.500

Device Problem Therapeutic or Diagnostic Output Failure (3023)

Patient Problem Patient Problem/Medical Problem (2688)

Event Date 12/09/2019

Event Type  Injury  

Manufacturer Narrative

By checking the manufacturing chart of the lot #1517481 no anomaly was detected.This is the first and only complaint received on this lot#.We will submit a final mdr once the investigation will be concluded.

Event Description

Revision surgery due to cuff failure occurred on (b)(6) 2019.Smr cta humeral head code 1323.09.500 lot #1517481 was explanted and converted to reverse.According to the information reported, patient had supraspinatus insufficiency with fatty infiltration throughout muscle.Primary surgery was performed on (b)(6) 2017.Event occurred in (b)(6).

Event Description

Revision surgery duo to cuff failure occurred on (b)(6) 2019.Smr cta humeral head code 1323.09.500 lot #1517481 was explanted and converted to reverse.According to the information reported, patient had supraspinatus insufficiency with fatty infiltration throughout muscle.Primary surgery was performed on (b)(6) 2017 and was due to glenohumeral osteoarthritis.The patient had a low level of physical activity and experienced reduced range of motion before the conversion to a reverse shoulder.Event occurred in australia.

Manufacturer Narrative

Check of the dhr: by checking the manufacturing chart of the lot #1517481, no pre-existing anomaly was detected on 18 smr cta humeral heads manufactured.This is the first and only complaint received on this lot#.Explants analiysis: explants were not available for technical analysis.Xrays analysis: we received pre-operative xrays (exact date unknown) and sent them to the medical consultant for clinical evaluation.Following, his comment is reported: "it is disappointing that in 2017 a cta arthroplasty is chosen as the first option for rotator cuff failure.It is not possible given we do not know the patient details but as a generalisation there are a number of non arthroplasty options for this situation.Looking at the image there is no obvious arthropathy although without the pre-operative images one cannot exclude mild arthropathic change.The generally accepted order of arhroplasty preference for cuff tear arthropathy is reverse followed by cta arthroplasty, which i recommend and teach should only be used in a "salvage" situation.From a technical point of view i can see no error.In summary, the indications for intervention if non arthroplasty options have been excluded then the first arthroplasty choice would be reverse.It would have saved the certain revision and a period of sub optimal out come." although from a technical point of view the medical consultant did not find any error, he indicated smr reverse as primary solution for cuff failure, after having excluded non arthroplasty options.In conclusion, stating that manufacturing documentation demonstrates that all the components belonging to lot #1517481 were up to specification and no further complaints were received on this lot#, and considering the opinion of the medical consultant, we can conclude that root cause of the event is not product related.We were unable to identify the certain root cause of the event, but we can hypothesize that it was due to the combination of suboptimal surgical choice and patient condition.Pms data: according to our pms data, we are were of only 6 cases of revision of cta head (product code 1323.09.Xxx-1323.15.Xxx) due to cuff failure, (b)(4).None of these cases was judged as product related.No corrective/preventive action implemented for this specific case.Limacorporate will keep the market monitored.

• Brand Name: SMR CTA HUMERAL HEAD
• Type of Device: SMR CTA HUMERAL HEAD(HSD-KWS )
• Manufacturer (Section D): LIMACORPORATE SPA; via nazionale 52; villanova di san daniele, udine 33038 ; IT 33038
• MDR Report Key: 9544840
• MDR Text Key: 188722154
• Report Number: 3008021110-2019-00149
• Device Sequence Number: 1
• Product Code: HSD
• Combination Product (y/n): N
• PMA/PMN Number: K110847
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: other
• Type of Report: Initial,Followup
• Report Date: 05/25/2020

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: 1323.09.500
• Device Lot Number: 1517481
• Initial Date Manufacturer Received: 12/10/2019
• Initial Date FDA Received: 01/03/2020
• Supplement Dates Manufacturer Received: 12/10/2019
• Supplement Dates FDA Received: 05/25/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention