MAUDE Adverse Event Report: LIMACORPORATE S.P.A SMR CEMENTLESS FINNED STEM L.80MM

Model Number 1304.15.140

Device Problems Loose or Intermittent Connection (1371); Device Dislodged or Dislocated (2923)

Patient Problems Failure of Implant (1924); Loss of Range of Motion (2032); Joint Dislocation (2374); No Code Available (3191)

Event Date 03/30/2017

Event Type  Injury  

Manufacturer Narrative

We performed a check of the manufacturing charts of the lot# of humeral stem involved (201612599) and no anomalies were detected on the 35 humeral stem manufactured with this lot#.No other complaints reported on this lot#.According to the information received, the humeral stem got loose from the humeral bone, rotated and started to come out of the humerus.The patient is an elderly lady who is not very physically active.The complaint source confirmed that the shoulder dislocation occurred because of the loosening of the stem in the humerus.He also advised that a larger stem should have possibly been implanted during the previous surgery and this may have avoided the loosening of the prosthesis.The explanted devices and the x-rays of primary and revision surgery were not available for analysis, therefore a deeper investigation was not possible.Event not product-related according to our investigation with the available info.Pms data: we are aware of 5 cases of aseptic loosening of the humeral stem on a total of (b)(4) smr cementless stem ((b)(4)) sold worldwide since 2002.The revision rate associated to this type of event is (b)(4)%.No corrective actions planned for this specific case.Limacorporate will keep monitoring the market on the reoccurrence of this event.

Event Description

Shoulder revision surgery due to anterior dislocation done on (b)(6) 2017.Patient experienced loss of range motion after only few months from the primary surgery, performed on (b)(6) 2016, where a smr reverse system had been implanted.According to the information received, the shoulder dislocation was caused by the loosening of the humeral stem from the humeral bone: the stem got loose and rotate, together with the humeral body, causing the shoulder dislocation.The surgeon was satisfied with the final stability of the implant after the revision surgery.Event occurred in (b)(6).

• Brand Name: SMR CEMENTLESS FINNED STEM L.80MM
• Type of Device: SMR CEMENTLESS FINNED STEM L.80MM
• Manufacturer (Section D): LIMACORPORATE S.P.A; via nazionale 52; villanova di san daniele, 33038 ; IT 33038
• Manufacturer (Section G): LIMACORPORATE S.P.A; via nazionale 52; villanova di san daniele, 33038 ; IT 33038
• Manufacturer Contact: giulio puppa ; IT
• MDR Report Key: 7167229
• MDR Text Key: 96458939
• Report Number: 3008021110-2017-00116
• Device Sequence Number: 1
• Product Code: KWT
• Combination Product (y/n): N
• Reporter Country Code: AS
• PMA/PMN Number: K101263
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: other
• Reporter Occupation: Other
• Type of Report: Initial

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/05/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Device Expiration Date: 09/30/2021
• Device Model Number: 1304.15.140
• Device Lot Number: 201612599
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/14/2016
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention