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

Model Number 1377.50.010

Device Problem Material Integrity Problem (2978)

Patient Problem Implant Pain (4561)

Event Date 08/31/2022

Event Type  Injury  

Manufacturer Narrative

By the check of the device history records, no pre-existing anomaly was detected on the 74 liners released with lot number 15at27n, ster.(b)(4).A final report will be submitted after the conclusion of the investigation.

Event Description

Shoulder revision surgery performed on (b)(6) 2022, due to pain.During the revision surgery, metallosis and wear of the liner (liner f.Met.Back glen.Standard code 137750010, lot 15at27n, ster.(b)(4)) were found.In addition to the liner, the following components were removed: smr humeral head ø48 mm code 132209480 lot 1517475 ster.(b)(4).Smr ecc.Adaptor taper standard code 133015278 lot 1515615 ster.(b)(4).Smr finned humeral body code 135015110 lot 1606585 ster.(b)(4).Smr glenoid baseplate standard code 137515670 lot 1520076 ster.(b)(4).According to the information received, the liner with product code 137750010 was used in combination with a baseplate that belong to product code 137515670.This is a not allowed combination.Anatomic smr with axioma bone graft had been implanted on (b)(6) 2016.The patient is male, 69 years old.This incident occurred in the uk.

Event Description

Shoulder revision surgery performed on (b)(6), 2022, due to pain.During the revision surgery, metallosis and wear of the liner (liner f.Met.Back glen.Standard code 1377.50.010, lot 15at27n, ster.1600133) were found.In addition to the liner, the following components were removed: - smr humeral head ø48 mm code 1322.09.480 lot 1517475 ster.1600051 - smr ecc.Adaptor taper standard code 1330.15.278 lot 1515615 ster.1600035 - smr finned humeral body code 1350.15.110 lot 1606585 ster.1600167 the complaint source reported that biopsies were taken and the plan was to convert to reverse if the biopsies resulted clear.A smr reverse prosthesis was then implanted on (b)(6), 2022.According to the information received, the liner with product code 1377.50.010 was used in combination with the following baseplate: smr glenoid baseplate standard code 1375.15.670 (lot 1520076 ster.1600073).This is a not allowed combination.Anatomic smr with axioma bone graft had been implanted on (b)(6) 2016.The patient is male, 69 years old.This event occurred in the united kingdom.

Manufacturer Narrative

By the check of the device history records, no pre-existing anomaly was detected on the 74 liners released with lot number 15at27n, ster.(b)(4).No x-rays were shared with limacorporate, therefore a deeper clinical analysis is not possible.The explanted devices were not available to be returned to limacorporate for analysis, due to hospital policy.Based on the provided information, the combination of liner and metal back implanted during the previous surgery is not allowed.The mechanical stress and wear condition resulting from this components combination are therefore abnormal and unexpected.The surgical technique and warning labels, clearly state that the metal back glenoids that belong to product code (b)(4), can only be coupled with the liners (b)(4), while in this case, a liner with code (b)(4) was used.In conclusion, this event is classified as surgical factor related.Pms data based on limacorporate pms data, the revision rate due to wear of the l1 liner (product codes (b)(4) is about 0.11%.However, based on the available information and investigation performed over time, none of these cases highlighted a similar incorrect implantation of l1 liner onto the metal back glenoid family 1375.15.6xx.No corrective action needed following this complaint.Limacorporate will continue monitoring the market to promptly detect any further similar event.

• Brand Name: LINER F.MET.BACK GLEN.STANDARD
• Type of Device: LINER FOR METAL-BACK (UHMWPE) LINER STANDARD
• Manufacturer (Section D): LIMACORPORATE S.P.A.; via naizonale 52; villanova di san daniele, udine 33038 ; IT 33038
• Manufacturer Contact: via nazionale 52; villanova di san daniele, udine 33038
• MDR Report Key: 15436338
• MDR Text Key: 300037263
• Report Number: 3008021110-2022-00083
• 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,Followup

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/16/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Model Number: 1377.50.010
• Device Lot Number: 15AT27N
• Is the Reporter a Health Professional?: No
• 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