MAUDE Adverse Event Report: LIMACORPORATE S.P.A. PRIMA HUMERAL SYSTEM; PRIMA STEM #3

Model Number 1357.14.032

Device Problem Mechanical Problem (1384)

Patient Problem Joint Dislocation (2374)

Event Date 10/18/2023

Event Type  Injury  

Event Description

Shoulder revision surgery performed on (b)(6), 2023, due to shoulder arthroplasty dislocation.Previous surgery performed on (b)(6), 2023.The following devices were explanted during revision surgery: prima stem #3 - ti6al4v (product code: 1357.14.032, lot.2302736 - ster.2300133).Prima rev.Insert #short d.44mm (product code: 1367.09.300, lot.2224231 - ster.2300021).Source complaint reported patient had alteration of bony anatomy due to previous proximal humerus fracture.Patient is male, 72 years old, approximate height (m) 1,75; approximate weight (kg) 82; activity level is sedentary.Event occurred in italy.

Manufacturer Narrative

No pre-existing anomaly was detected by the check of manufacturing charts of involved lot nr: 2302736.This is the first complaint received on the lot number involved.We will submit a final report after the final investigation.

Manufacturer Narrative

No pre-existing anomaly was detected by the check of manufacturing charts of lot nr: 2302736.According to our records, at least 13 out of 19 with lot.2302736 - ster.2300133 have been implanted and this is first and only complaint received on this lot nr.The devices were not returned for further investigation.The complaint source provided four x-rays to limacorporate with reference to: primary surgery: post - op x-rays.Revision surgery: pre - op x-rays and post - op x-rays.The x-rays received were evaluated by a medical expert.Following, the medical expert comments:"the prima seem to be quite proud in the humerus or better on the humerus.This may have led to overtensioning[?], but this is rather rare for instability.The glenoid baseplate and the glenosphere are orientated upward, not downward.This is a surgical error.I cannot say, why the prosthesis did dislocate, but it is not implant-related.I would not go so far to say, that the use of prima was a contraindication, i use a lot of stemless in fracture sequelae, so prima should be suitable for this as well." based on the information received, we are not able to further investigate the root cause of the event.However, considering that: the check of the manufacturing chart highlighted no anomalies on the component manufactured with the involved lot numbers.And according to the analysis performed by the medical expert.We can classify the event as not product related.Pms data: according to limacorporate pms data, the revision rate of prima stem (product code: 1357.14.Xxx) due to dislocation is nearly 0,31%.No corrective actions required for this specific case.Limacorporate will continue monitoring the market to promptly detect any further similar issue.This is an mdr final report.

Event Description

Shoulder revision surgery performed on (b)(6), 2023, due to shoulder arthroplasty dislocation.Previous surgery performed on (b)(6), 2023.Source complaint reported patient had alteration of bony anatomy due to previous proximal humerus fracture.The following devices were explanted during revision surgery: prima stem #3 - ti6al4v (product code: 1357.14.032, lot.2302736 - ster.2300133) )- sold in us.Prima rev.Insert #short d.44mm (product code: 1367.09.300, lot.2224231 - ster.2300021).Smr small/std connector +2 (product code: 1374.15.322, lot.2213447 - ster.2200191).Smr reverse hp glenosph.44 mm (product code: 1374.50.440, lot.2218844 - ster.2200223).Smr glenoid peg tt s/std #s (product code: 1375.14.661, lot.2104939 - ster.2100286).Smr glenoid baseplate standard (product code: 1375.15.670, lot.2222551 - ster.2200307).Bone screw ø6,5 h.30mm (product code: 8420.15.030, lot.2317253 - ster.2300166).Bone screw ø6,5 h.35mm (product code: 8420.15.040, lot.2317255 - ster.2300166).Source complaint reported patient had alteration of bony anatomy due to previous proximal humerus fracture.Patient is male, 72 years old, approximate height (m) 1,75; approximate weight (kg) 82; activity level is sedentary.Event occurred in italy.

• Brand Name: PRIMA HUMERAL SYSTEM
• Type of Device: PRIMA STEM #3
• Manufacturer (Section D): LIMACORPORATE S.P.A.; via nazionale 52; villanova di san daniele, udine 33038 ; IT 33038
• MDR Report Key: 18739564
• MDR Text Key: 335811487
• Report Number: 3008021110-2024-00019
• Device Sequence Number: 1
• Product Code: HSD
• Combination Product (y/n): N
• PMA/PMN Number: K212800
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Distributor
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 02/20/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/20/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Model Number: 1357.14.032
• Device Lot Number: 2302736
• Date Manufacturer Received: 02/09/2024
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention