MAUDE Adverse Event Report: LIMACORPORATE S.P.A. SMR CEMENTLESS FINNED STEM 19; FINNED HUMERAL STEMS - 80MM (TI6AL4V) DIA.19MM

Model Number 1304.15.190

Device Problem Break (1069)

Patient Problems Bacterial Infection (1735); Erythema (1840); Pain (1994); Loss of Range of Motion (2032); Metal Related Pathology (4530); Swelling/ Edema (4577)

Event Date 12/07/2020

Event Type  Injury  

Event Description

Revision surgery of smr anatomic system performed on (b)(6) 2020.Cause for revision was breakage of l2 liner; product code: 1377.51.070, lot# 1007293, ster.1000227 (please note: l2 liner is not sold in us).According to the information reported by the complaint source, patient was going about his normal daily activities when he felt a cracking sound followed by significant pain, and loss of range of motion.He consulted the surgeon who upon examining the scans realised l2 liner had dissociated.There were also obvious signs of infection with swelling, redness and tenderness in the effected areas.The usual observations were made with extensive poly debris and black tissue as a result of the metalosis.Swabs and samples were taken and sent to pathology.The poly debris was cleaned from the wound in addition to the blackened tissue before all components were removed from the patient.The wound was irrigated, antibiotics administered and closed up.According to the info received from complaint source, patient will be monitored for the effectiveness of the antibiotics and further evaluation will be done once infection will be under control.All the following components were explanted: smr cementless finned stem ø19; product code: 1304.15.190; lot #: 1001195; ster.1000064; smr humeral head ø44 mm ; product code: 1322.09.440; lot #: 1003318; ster.1000160; smr ecc.Adaptor taper standard product code 1330.15.274 lot #: 1007254; ster.1000216; smr finned humeral body product code: 1350.15.110; lot #: 1003334 ster.1000160 cementless glenoid standard; product code: 1375.25.070 lot#1004507 ster.1000197 liner f.Met.Back glen.Standard; product code: 1377.51.070 lot#1007293 ster.1000227 bone screw ø6,5 h.20mm; product code 8420.15.010; lot#1004058-1004825; ster.1000171-1000189.Primary surgery was performed on (b)(6) 2010.Event occurred in (b)(6).

Manufacturer Narrative

By checking the sterilization charts of the involved lots, no pre-existing anomaly was found on the overall number.Therefore, we can ensure that all the products with these lots have been properly sterilized before being placed on the market.Further complaints due to l2 breakeage were received on the specific lot#1007293.Limacorporate received a total of two x-rays referring to pre-op revision surgery and a couple of pictures of the explants.The x-rays received - dated 23th of november 2020 - have been evaluated by a medical consultant.Following, the medical consultant comments: "in addition to the obvious possibility of the l2-liner problem i see two more problems here, that might have interfered.The signs of infection are dubious and could be cause of implant loosening due to swelling, loss of contact and instability over time.Nevertheless, after 10 years infection out of the blue is rare.Looking at the ap-radiographs the humeral component is clearly in a very suboptimal varus position with increased offset.This puts high pressure on the head-liner interface and can cause instability and early loosening.This is at least a very relevant comorbidity, if not the leading pathology here".Considering that: - checking the sterilization charts of the involved products, no anomalies were found; - according to the medical expert's opinion, "after 10 years infection out of the blue is rare.Looking at the ap-radiographs the humeral component is clearly in a very suboptimal varus position with increased offset.This puts high pressure on the head-liner interface and can cause instability and early loosening"; we can state that the event is not product related.Note: this is a final mdr.

Event Description

Revision surgery of smr anatomic system performed on (b)(6), 2020 due to breakage of l2 poly liner (product code 1377.51.070, lot# 1007293, ster.1000227 - please note: l2 liner is not sold in us) and infection.Primary surgery was performed on (b)(6), 2010.According to the information reported by the complaint source, patient was going about his normal daily activities when he felt a cracking sound followed by significant pain and loss of range of motion.He consulted the surgeon who upon examining the scans realised l2 poly liner had dissociated.There were also obvious signs of infection with swelling, redness and tenderness in the effected areas.All the following components were explanted: · smr cementless finned stem ø19 (product code 1304.15.190, lot#1001195 - ster.1000064).· smr humeral head ø44 mm (product code 1322.09.440, lot#1003318 - ster.1000160).· smr ecc.Adaptor taper standard (product code 1330.15.274, lot#1007254 - ster.1000216).· smr finned humeral body (product code 1350.15.110, lot#1003334 - ster.1000160).· cementless glenoid standard (product code 1375.25.070, lot#1004507 - ster.1000197).· liner f.Met.Back glen.Standard (product code 1377.51.070, lot#1007293 - ster.1000227).· bone screw ø6,5 h.20mm (product code 8420.15.010, lot#1004058 - ster.1000171).· bone screw ø6,5 h.20mm (product code 8420.15.010, lot#1004825 - ster.1000189).Among the above cited components, the following ones are sold in the us: · smr cementless finned stem ø19 (product code 1304.15.190, lot#1001195 - ster.1000064).· smr humeral head ø44 mm (product code 1322.09.440, lot#1003318 - ster.1000160) · smr ecc.Adaptor taper standard (product code 1330.15.274, lot#1007254 - ster.1000216).· smr finned humeral body (product code 1350.15.110, lot#1003334 - ster.1000160).· bone screw ø6,5 h.20mm (product code 8420.15.010, lot#1004058 - ster.1000171).· bone screw ø6,5 h.20mm (product code 8420.15.010, lot#1004825 - ster.1000189).Patient will be monitored for the effectiveness of the antibiotics before taking a final decision on future prosthesis to be implanted.

• Brand Name: SMR CEMENTLESS FINNED STEM 19
• Type of Device: FINNED HUMERAL STEMS - 80MM (TI6AL4V) DIA.19MM
• Manufacturer (Section D): LIMACORPORATE S.P.A.; via nazionale 52; villanova di san daniele, udine 33038 ; IT 33038
• MDR Report Key: 11028354
• MDR Text Key: 222305758
• Report Number: 3008021110-2020-00113
• Device Sequence Number: 1
• Product Code: HSD
• Combination Product (y/n): N
• PMA/PMN Number: K101263
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: other
• Type of Report: Initial,Followup
• Report Date: 06/11/2021

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: 1304.15.190
• Device Lot Number: 1001195
• Initial Date Manufacturer Received: 12/10/2020
• Initial Date FDA Received: 12/17/2020
• Supplement Dates Manufacturer Received: 12/10/2020
• Supplement Dates FDA Received: 06/16/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention