MAUDE Adverse Event Report: LIMACORPORATE S.P.A. SMR HUMERAL HEAD Ø46 MM; HUMERAL HEADS (COCRMO) DIA.46MM

Model Number 1322.09.460

Device Problem Device Dislodged or Dislocated (2923)

Patient Problem Joint Dislocation (2374)

Event Date 12/06/2022

Event Type  Injury  

Event Description

Shoulder revision surgery of a smr stemless anatomic prosthesis performed on (b)(6) 2022, due to cuff failure.According to the surgeon operating the revision surgery (different from the one who performed the previous surgery), the patient could have had a suspect cuff before primary procedure.Primary surgery took place on (b)(6) 2022.In addition, the subscapularis was of poor quality during the revision surgery according to the received information.The following components were explanted, and the prosthesis was converted to reverse: smr humeral head ø46 mm (product code 1322.09.460, lot #1904990 - ster.1900158) smr stemless - 2mm eccentric adaptor (product code 1335.15.202, lot #1819665 - ster.1900025) tt hybrid glenoid small (product code 1379.59.110, lot #2118190 - ster.2100301).The hybrid peg was left in situ.A tt hybrid reverse baseplate was implanted.Patient is a female, 67 years old.Event happened in (b)(6).

Manufacturer Narrative

Checking the manufacturing charts of the involved lot #1904990, no pre-existing anomaly was found on a total of 66 items manufactured with the same lot #.According to our records, at least 46 out of 66 humeral heads with lot #1904990 - ster.1900158 have been implanted and this is the only complaint received on this lot #.The operational notes from primary surgery were shared.It was reported on them that "a deltopectoral approach was accomplished.Cephalic vein was carried out medially with cauterization of the lateral perforators.Clavipectoral fascia was entered and subcoracoid, subacromial and subdeltoid spaces were all cleared.The cuff was in good integrity".No additional details were available on this post-operative issue, specifically the following information was requested to the complaint source, but it was not available: · the explanted devices; · pre-operative or post-operative x-rays related to the revision surgery; · clinical data for the patient.Based on the very few information received, we are not able to further investigate the root cause of the event.Considering that: · according to the surgeon responsible for this conversion surgery (different from the one responsible for the primary surgery), there could have been a suspect cuff before primary procedure; · according to the operational notes from primary surgery "the cuff was in good integrity"; we cannot define the root cause of the event.However, considering that check of the manufacturing charts highlighted no anomalies on components manufactured with lot #1904990, we can state that the event was not product related.Pms data according to limacorporate pms data, we estimate the revision rate of shoulder anatomic implants with humeral heads - belonging to product codes 1321/1322/1324/1325.09/15.Xxx - due to cuff failure to be 0,24%.Based on the root cause analysis performed and according to the relevant pms data, no corrective actions required for this specific case.Limacorporate will continue monitoring the market to promptly detect any further similar issue.Note: this is a combined initial-final mdr.

• Brand Name: SMR HUMERAL HEAD Ø46 MM
• Type of Device: HUMERAL HEADS (COCRMO) DIA.46MM
• Manufacturer (Section D): LIMACORPORATE S.P.A.; via nazionale 52; villanova di san daniele, udine 33038 ; IT 33038
• MDR Report Key: 16013588
• MDR Text Key: 305786500
• Report Number: 3008021110-2022-00132
• Device Sequence Number: 1
• Product Code: KWT
• Combination Product (y/n): N
• PMA/PMN Number: K100858
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 12/19/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/20/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Model Number: 1322.09.460
• Device Lot Number: 1904990
• 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