MAUDE Adverse Event Report: LIMACORPORATE S.P.A. SMR HUMERAL HEADS (COCRMO) DIA.42MM

Model Number 1322.09.420

Device Problem Inadequacy of Device Shape and/or Size (1583)

Patient Problem Pain (1994)

Event Date 03/24/2017

Event Type  Injury  

Manufacturer Narrative

The check of the manufacturing charts of the lot# of the smr humeral head involved (201407219) did not show any anomaly on the (b)(4) smr humeral head manufactured with this lot #.No other complaints reported on this lot#.We will send a final report once the investigation will be completed.

Event Description

Shoulder revision surgery done on (b)(6) 2017 due to reported patient pain.During the primary surgery, done on (b)(6) 2014, the following components have been implanted: · smr humeral head dia.42mm, model# 1322.09.420, lot#201407219; · smr eccentric adaptor taper standard, model# 1330.15.272, lot# 201409541; · smr finned humeral body, model# 1350.15.110, lot# 201404124.Surgeon remarks that a 40mm humeral head would have been the ideal solution even at the time of the primary surgery but that size was not available on the (b)(4) market at that time.Even if no issues in regards to stability or excessive tightness of the joint have been noticed post primary surgery, during revision surgeon decided to replace the finned humeral body, the humeral head dia.42mm and the eccentric 2mm adaptor taper; surgeon reduced the head size to a dia.40 mm with the aim of lowering the humerus in order to not place excessive stress upon the rotator cuff, probable cause of patient pain.Surgeon satisfied either with the final stability of the implant, either with the obtained range of motion and tension on the rotator cuff muscles.Event happened in (b)(6).

Manufacturer Narrative

The check of the manufacturing charts of the lot# of the smr humeral head involved (201407219) did not show any anomaly on the 72 smr humeral head manufactured with this lot #.No other complaints reported on this lot#.We asked for further information on this case, but no additional information is available, therefore a deep investigation is not possible.Surgeon remarks after the revision confirm that this is not a product-related case, but a case of patient pain basically due to suboptimal size of the humeral head implanted on (b)(6) 2014.Pms data: we are aware of a total of 12 revision surgeries involving smr anatomic total prostheses specifically related to pain associated to unspecified reason, on a total of 18.697 smr anatomic total prosthesis sold ww since 2003.The revision rate associated to this type of event is (b)(4).No corrective action planned for this specific case.Limacorporate will keep monitoring the market.

Event Description

Shoulder revision surgery done on (b)(6) 2017 due to reported patient pain.During the primary surgery, done on (b)(6) 2014, the following components (smr anatomic total prosthesis) had been implanted: smr humeral head dia.42mm, model# 1322.09.420, lot#201407219; smr eccentric adaptor taper standard, model# 1330.15.272, lot# 201409541; smr finned humeral body, model# 1350.15.110, lot# 201404124.Surgeon remarked that a 40mm humeral head would have been the ideal solution even at the time of the primary surgery but that size was not available on the (b)(6) market at that time.Even if no issues in regards to stability or excessive tightness of the joint have been noticed post primary surgery, during revision surgeon decided to replace the finned humeral body, the humeral head dia.42mm and the eccentric 2mm adaptor taper; surgeon reduced the head size to a dia.40 mm with the aim of lowering the humerus in order to not place excessive stress upon the rotator cuff, probable cause of patient pain.Surgeon satisfied either with the final stability of the implant , either with the obtained range of motion and tension on the rotator cuff muscles.Event happened in (b)(6).

• Brand Name: SMR HUMERAL HEADS (COCRMO) DIA.42MM
• Type of Device: SMR HUMERAL HEADS (COCRMO) DIA.42MM
• 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 ; via nazionale, 52; villanova di san daniele, 33038 ; IT 33038
• MDR Report Key: 6539682
• MDR Text Key: 74255565
• Report Number: 3008021110-2017-00034
• 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: 12/21/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/03/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 07/31/2019
• Device Model Number: 1322.09.420
• Device Lot Number: 201407219
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/18/2014
• 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