MAUDE Adverse Event Report: LIMACORPORATE SPA SMR CTA HUMERAL HEAD Ø42 MM; SMR CTA HUMERAL HEAD Ø42 MM (HSD-KWS)

Model Number 1323.09.420

Device Problem Material Erosion (1214)

Patient Problem Arthralgia (2355)

Event Date 11/13/2019

Event Type  Injury  

Manufacturer Narrative

By checking the dhr of the lot #: 0901703 ster.1500086 no anomaly was found.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 painful joint occurred on (b)(6) 2019.Previous surgery was performed on (b)(6) 2017.During revision surgery, smr cta humeral head code 1323.09.420 lot #: 0901703 was explanted.Revision stem was left in situ.Patient has had a hemiarthroplasty with a cta head since the last revision.According to the information reported, the cta head was riding high on the acromian, eroding the glenoid and causing pain.No future revision is planned unless pain does not subside.Event occurred in (b)(6).

Event Description

Revision surgery due to painful joint occurred on (b)(6) 2019.Previous surgery was performed on (b)(6) 2017.During revision surgery, smr cta humeral head code 1323.09.420 lot # 0901703 was explanted.Revision stem was left in situ.According to the information reported, the cta head was riding high on the acromian, eroding the glenoid and causing pain.No future revision is planned unless pain does not subside.Event occurred in australia.

Manufacturer Narrative

Check of the dhr: by checking the manufacturing chart of the lot # 0901703 ster.1500086 no pre-existing anomaly was found on 20 smr cta humeral heads manufactured.This is the first and only complaint received on this lot#.Ct-slices analysis: we received pre-revision ct-slices (exact date unknown) and sent them to our medical consultant for analysis.Following, his comment is reported: "as the report suggests the cta head has migrated superiorly out of the glenoid and into the supraspinatus fossa.The one redeeming feature is the head is still contained within the coracoacromial arch.There has been erosion of the acromion and outer end of clavicle and apparent extreme bone loss from the glenoid but these are ct slices and do not likely truely represent the total glenoid.The humeral component appears well fixed with no obvious features of loosening.We know from experience that a cta head is almost never associated with a good patient outcome so it is not surprising the patient has pain.That said pain in revision situations should always raise suspicion for infection.In summary while no doubt the patient is unhappy this is the expected outcome of a cta head.I do not see any technical aspects of the surgery that would cause concern." according to the medical consultant, ct-slices provided by the complaint source do not allow a complete analysis of the case.However, he confirmed that cta head migrated superiorly into the supraspinatus fossa, but it was still within the coracoacromial arch.It was also confirmed that there has been erosion of the acromion and outer end of clavicle and apparent extreme bone loss from the glenoid.According to the medical consultant, there were no aspects related to the surgery or to the product itself related to the negative abovementioned outcomes.A further possible cause for pain could have been infection, but the complaint source did not report any swab analysis.Considering that: all the components manufactured with lot #0901703 were up to specifications and no further complaints were received on this lot# the medical consultan did not find any anomaly in the surgery that could have been responsible for failure of the prosthesis we can conclude that the event is due to patient clinical condition.Event not product related.Pms data according to our pms data, revision rate of cta heads (family of code 1323.09.Xxx - 1323.15.Xxx) due to pain is 0.08%.None of these event 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 Ø42 MM
• Type of Device: SMR CTA HUMERAL HEAD Ø42 MM (HSD-KWS)
• Manufacturer (Section D): LIMACORPORATE SPA; via nazionale 52; villanova di san daniele, udine 33038 ; IT 33038
• MDR Report Key: 9353660
• MDR Text Key: 167351362
• Report Number: 3008021110-2019-00130
• 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: 05/06/2020

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: 1323.09.420
• Device Lot Number: 0901703
• Initial Date Manufacturer Received: 11/14/2019
• Initial Date FDA Received: 11/21/2019
• Supplement Dates Manufacturer Received: 11/14/2019
• Supplement Dates FDA Received: 05/06/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention