MAUDE Adverse Event Report: LIMACORPORATE S.P.A. SMR HUMERAL HEAD COCRMO; SMR HUMERAL HEAD COCRMO DIA 48MM

Model Number 1322.09.480

Device Problem Device Operates Differently Than Expected (2913)

Patient Problems Fall (1848); Bone Fracture(s) (1870); Pain (1994); Loss of Range of Motion (2032)

Event Date 04/26/2016

Event Type  Injury  

Manufacturer Narrative

The humeral head is the specific device supposed to cause pain and decreased range of motion over time.The check of the dhr of the specific lot # involved (1211146) did not show any pre-existing anomaly on the 60 humeral head manufactured with this lot #.No other complaints reported on this lot#.The check of the dhr of all the other lot # involved (stem, humeral body, adaptor taper which were also explanted) did not show any pre-existing anomaly on all these components.No other complaints reported on this lot #.Also the sterilization charts of all the above lot # were checked, due to indication of possible infection; all these devices were regularly sterilized before being placed on the market.We will submit a final mdr after the complete investigation.

Event Description

Revision surgery (3 years after primary surgery) due to pain and decreased range of motion over time.Patient had a primary surgery after a fall where a humeral head fracture has been sustained.The revision was a conversion of left shoulder hemi arthroplasty to total reverse arthroplasty after complaining of pain and decreased rom.Due to relative easiness to remove the stem and humeral body from the humeral canal, tissue samples of patient's shoulder were removed intra-op for pathology assessment, in order to determine if any infection gave rise.Event occurred in (b)(6).

Manufacturer Narrative

The check of the dhr of the specific lot # of humeral head involved (201211146) did not show any pre-existing anomaly on the 60 humeral heads manufactured with this lot #.No other complaints reported on this lot#.The check of the dhr of all the other lot # involved (stem, humeral body, adaptor taper which were also explanted) did not show any pre-existing anomaly on all these components.No other complaints reported on these lot #.Also the sterilization charts of all the above lot # were checked, due to indication of possible infection; all these devices were regularly sterilized before being placed on the market.We received the x-rays and we asked for a medical expert's opinion.The medical expert checked the pre-op primary x-rays and confirmed that the use of a hemi arthroplasty was a reasonable choice for a fractured humerus during the primary procedure.Regarding the pre-operative x-rays of the revision surgery, the medical expert could not comment on the head size or height.However, he suspected that the tuberosity fixation was not ideal.The tuberosity looked indeed malpositioned and no wires were used.Therefore, it is possible that the surgeon used a fiber tape or something similar which is not visible on x-rays.Moreover, according to the medical expert, if the specimens taken during revision surgery were negative for infection, the most probable cause for revision surgery was the malpositioning of the tuberosities, which could have not been related to the prosthesis.We did not receive the results of the tests performed to determine whether an infection was present, but according to the check of the sterilization charts, all the devices were regularly sterilized.In conclusion, we can suppose that the revision surgery was not related to the prosthesis itself, but was caused by external factors (malpositioning of the tuberosities or possible infection).Pms data: we are aware of 7 cases of revision surgery due to pain and loss of range of motion involving a smr hemi prosthesis on a total of (b)(4) smr hemi prosthesis sold ww since 2002.The revision rate is 0,036%.

Event Description

On (b)(6) 2016, shoulder revision surgery (3 years after primary surgery - performed on (b)(6) 2013) was performed due to pain and decreased range of motion over time.Patient had the primary surgery after a fall where a humeral head fracture has been sustained.The revision was a conversion of left shoulder hemi arthroplasty to total reverse arthroplasty after complaining of pain and decreased range of motion.Due to relative easiness to remove the stem and humeral body from the humeral canal, tissue samples of patient's shoulder were removed intra-op for pathology assessment, in order to determine if any infection have risen.Event occurred in (b)(6).

• Brand Name: SMR HUMERAL HEAD COCRMO
• Type of Device: SMR HUMERAL HEAD COCRMO DIA 48MM
• 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, udine 33038 ; IT 33038
• Manufacturer Contact: giulio puppa ; via nazionale, 52; villanova di san daniele, 33038 ; IT 33038 ; 2 945511
• MDR Report Key: 6169509
• MDR Text Key: 62675896
• Report Number: 3008021110-2016-00044
• 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,Followup
• Report Date: 09/21/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/13/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: 1322.09.480
• Device Lot Number: 201200457
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 05/24/2016
• Was Device Evaluated by Manufacturer?: 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