MAUDE Adverse Event Report: LIMACORPORATE S.P.A. LINER FOR METAL BACK GLENOID STANDARD; LINER FOR METAL-BACK (UHMWPE) LINER STANDARD

Model Number 1377.50.010

Device Problems Material Separation (1562); Device Dislodged or Dislocated (2923); Scratched Material (3020); Therapeutic or Diagnostic Output Failure (3023)

Patient Problem Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Date 12/09/2021

Event Type  Injury  

Event Description

Shoulder revision surgery of a smr anatomic implant performed on (b)(6) 2021, due to rotator cuff failure.It was reported that the liner for metal back glenoid standard (product code 1377.50.010, lot # 1215370 - ster.1300052) was found to be dislodged from the baseplate and was floating in the joint.According to the complaint source there was significant scratching on the humeral head from articulating on the metal back glenoid.The following components were explanted: liner for metal back glenoid standard (product code 1377.50.010, lot #1215370 - ster.1300052), smr humeral head ø44 mm (product code 1322.09.440, lot #1202943 - ster.1200131), neutral adaptor taper standard (product code 1330.15.270, lot #1213627 - ster.1300042), smr finned humeral body (product code 1350.15.110, lot #1101222 - ster.1100157), the prosthesis was converted to reverse.Patient is a male, (b)(6).He has a bmi of 30.According to the reported information, patient's primary surgery was performed on (b)(6) 2011.The first revision surgery took place on (b)(6) 2013, and it was due to the dissociation of the l2 liner (product not marketed in the us).The revision surgery was registered as complaint # (b)(4).Event happened in (b)(6).

Manufacturer Narrative

By checking the manufacturing charts of the involved lot #1215370, no pre-existing anomaly was found on a total of 23 items manufactured with the same lot #.According to our records, at least 22 out of 23 liners with lot #1215370 - ster.1300052 have been implanted and this is the only complaint received on this lot #.By checking the manufacturing charts of the involved lot #1202943 - ster.1200131, no pre-existing anomaly was found on a total of 31 items manufactured with the same lot # - ster.According to our records, at least 30 out of 31 humeral heads with lot #1202943 - ster.1200131 have been implanted and this is the only complaint received on this lot #.No much details are available on this post-operative issue, specifically the following information was requested to the complaint source, but it was not available: pre-operative x-rays related to the revision surgery; explanted components for analysis.Pictures of the explanted liner were shared with limacorporate, confirming the peg of the component was damaged.Based on the few information received, we are not able to further investigate at this stage the root cause of the event.However, considering that the check of the manufacturing charts highlighted no anomalies on the manufactured components of the involved lot #s and that the item was originally implanted in 2013, we can state that the event was not product related.Pms data: according to limacorporate pms data, the revision rate of l1 liners - belonging to product codes 1377.50.005, 1377.50.010, 1377.50.020, 1377.50.030 - due to dislocation/ breakage is (b)(4).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: LINER FOR METAL BACK GLENOID STANDARD
• Type of Device: LINER FOR METAL-BACK (UHMWPE) LINER STANDARD
• Manufacturer (Section D): LIMACORPORATE S.P.A.; via nazionale 52; villanova di san daniele, udine 33038 ; IT 33038
• MDR Report Key: 13059014
• MDR Text Key: 282792519
• Report Number: 3008021110-2021-00107
• Device Sequence Number: 1
• Product Code: KWS
• Combination Product (y/n): N
• PMA/PMN Number: K113254
• 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: 12/16/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/22/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Model Number: 1377.50.010
• Device Lot Number: 1215370
• 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): Other