MAUDE Adverse Event Report: LIMACORPORATE S.P.A. SMR HUMERAL HEADS (COCRMO) DIA.54MM; KWT

Model Number 1322.09.540

Device Problem Insufficient Information (3190)

Patient Problems Unspecified Infection (1930); Muscular Rigidity (1968); Pain (1994); Swelling (2091); Complaint, Ill-Defined (2331)

Event Date 03/23/2015

Event Type  Injury  

Event Description

Primary smr anatomic total was performed on (b)(6) 2011.In 2015, the patient had a foot infection and one week later he started complaining of shoulder pain, stiffness, localized swelling and heat.Revision surgery was performed on the (b)(6) 2015; on opening, approximately 200 ml of pus was drained.The smr prosthesis was removed.A biomet shoulder spacer was implanted and the patient was treated with iv antibiotics.The event occurred in (b)(6).

Manufacturer Narrative

The check of the dhr of the devices explanted (humeral head, humeral body, metal back glenoid, liner for metal back and neutral adaptor) confirmed that all of them were regularly sterilized before being placed on the market.We received no other similar complaints on these lot number and sterilization number.The available x-rays underwent a medical judgment; according to this evaluation, there is a visible loosening of the prosthesis from the bone in both the humeral and glenoid part.The x-rays show no mechanical failure or malfunction of the devices.A photo of the explants shows no osseointegration on them, even if their duration "in vivo" was 42 months.Additional information (type of infection and date of onset, possible predisposition of the patient) are not available.By the info provided, patient infection started from the foot, one week later the patient started complaining of shoulder pain and swelling; this indicates that the prosthesis itself is not the cause of the infection, it appears that patient was somehow predisposed to the event.(b)(4).No corrective actions for this specific case have been defined.Limacorporate will keep the market monitored.Not returned.

• Brand Name: SMR HUMERAL HEADS (COCRMO) DIA.54MM
• Type of Device: KWT
• Manufacturer (Section D): LIMACORPORATE S.P.A.; via nazionale 52; san daniele del friuli, udine 3303 8; IT 33038
• Manufacturer (Section G): LIMACORPORATE S.P.A.
• Manufacturer Contact: giulio puppa ; via nazionale 52; san daniele del friuli, udine 33038 ; IT 33038
• MDR Report Key: 4865174
• MDR Text Key: 5811188
• Report Number: 3008021110-2015-00025
• Device Sequence Number: 1
• Product Code: KWT
• Combination Product (y/n): N
• Reporter Country Code: AS
• 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: 05/24/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/24/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 06/30/2016
• Device Model Number: 1322.09.540
• Device Lot Number: 200703078
• Date Manufacturer Received: 05/25/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/27/2011
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention