MAUDE Adverse Event Report: SYNTHES MONUMENT COCR HEAD, 44MM/16.50MM-STERILE; PROSTHES,SHOULDER,NONCONSTRAIN,METALPOLYMER,CEMENT

Catalog Number 5331-44/16

Device Problems Difficult to Remove (1528); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Pain (1994); Scar Tissue (2060); Non-union Bone Fracture (2369); Impaired Healing (2378); Limited Mobility Of The Implanted Joint (2671)

Event Type  Injury  

Event Description

Attorney advised that patient suffered a right proximal humeral head fracture and underwent hemiarthroplasty of the right shoulder on (b)(6) 2010.The procedure lasted three hours, although from incision to end the procedure took two hours and four minutes.The patient was implanted with the following surgical hardware: humeral stem, 8/120mm press fit, eccenter and cocr head 44mm/16.50mm.Patient developed a non-union of the greater tuberosities and suffered from an anterior superior escape from a chronic retracted rotator cuff tear.The patient suffered from virtually no function and a revision surgery to reverse total shoulder prosthesis was recommended by another surgeon at a different hospital.The patient alleges that while using the product in accordance with its intended use, was caused to suffer and sustain severe bodily injuries.Patient underwent revision hemiarthroplasty at another hospital to the right shoulder to a depuy reverse cemented long stem with a 6mm polyethylene insert and a 42mm eccentric glenosphere, with removal of hemiarthroplasty and osteotomy of the humerus and open reduction internal fixation of the humeral shaft using three non-synthes tensioning cable.During the revision surgery on (b)(4)2011, the surgeon noted abundant scar tissue and difficulty peeling and recreating the subdeltoid bursa, with no subscapularis muscle in the front.The synthes prosthesis was reported as being just below the deltopectoral interval.The surgeon was unable to remove the synthes humeral stem that was proximally coated ingrown stem and the synthes extraction set would not dislodge the prosthesis.Multiple attempts were made to dislodge the well-fixed ingrown humeral stem without success.A sagittal saw was used to perform a humeral osteotomy to split the shaft longitudinally.Osteotomes were used to gently open the canal.This freed the prosthesis and the prosthesis was back-slapped out of the humerus.Non-synthes cables were used to fix the humeral shaft without difficulty.This is report 3 of 3 for complaint (b)(4).

Manufacturer Narrative

(b)(4)- rotator cuff tear review of the device history record showed that there were no issues during the manufacture/packaging of the product that would contribute to this complaint condition.: unknown note: blank fields on this form indicate information that is unknown, unavailable or unchanged.

• Brand Name: COCR HEAD, 44MM/16.50MM-STERILE
• Type of Device: PROSTHES,SHOULDER,NONCONSTRAIN,METALPOLYMER,CEMENT
• Manufacturer (Section D): SYNTHES MONUMENT; 1101 synthes avenue; monument CO 80132
• Manufacturer (Section G): SYNTHES MONUMENT; 1101 synthes avenue; monument CO 80132
• Manufacturer Contact: linda plews ; 1302 wrights lane east; west chester, PA 19380 ; 8006207025
• MDR Report Key: 4791525
• MDR Text Key: 17298419
• Report Number: 1719045-2015-00003
• Device Sequence Number: 1
• Product Code: KWT
• Combination Product (y/n): N
• PMA/PMN Number: K072578
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other
• Reporter Occupation: Attorney
• Type of Report: Initial
• Report Date: 04/30/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/22/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 12/31/2016
• Device Catalogue Number: 5331-44/16
• Device Lot Number: C000024
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 04/30/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/18/2008
• Is the Device Single Use?: Yes
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention