MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US UNKNOWN SHOULDER HUMERAL HEADS

Catalog Number UNK SHOULDER HUMERAL HEAD

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Stroke/CVA (1770); Hematoma (1884); Unspecified Infection (1930); Pain (1994); Injury (2348); Impaired Healing (2378); Not Applicable (3189); No Code Available (3191)

Event Type  Injury  

Manufacturer Narrative

(b)(4).No device was received.Root cause undetermined.Depuy synthes considers the investigation closed at this time.Should additional information be received, the information will be reviewed and the investigation may be re-opened as necessary.(b)(4).If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.(b)(4).

Event Description

"in the article ¿the results of arthroplasty in osteoarthritis of the shoulder¿ by j.F.Haines; i.A.Trail; d.Nuttall; a.Birch; and a.Barrow; published in the journal of bone and joint surgery (br), vol.88-b, no.4, april 2006, was reviewed.The purpose of the study was to analyze 1124 shoulder arthroplasties (113 patients) carried out for osteoarthritis.The clinical results showed improvement in the constant score and the american shoulder and elbow surgeons score of 22 and 43, respectively.The arthroplasties were performed between 1992 and 2002 using the global shoulder replacement (depuy international, ltd, leeds, united kingdom).42 patients had humeral head replacement and 82 had tsa.The study reports significant improvement after operation in all parameters studied.The article states that the global shoulder replacement gives good results with significant functional improvement, which is subsequently maintained.It also reports that when the rotator cuff is intact, superior migration did not occur; glenoid erosion and a poor rotator cuff are related to poor results.Complications noted are: two patients experienced a hematoma which required surgical drainage.Three patients experienced infection.One patient experienced a nerve injury which recovered partially.Two patients had a fracture of the humeral shaft occur intraoperatively.One patient experienced a cerebrovascular accident within one month of surgery.Patients were also noted to experience pain, superior migration, glenoid erosion and glenoid loosening.

Manufacturer Narrative

Product complaint # (b)(4).(b)(4) used to capture joint instability.

• Brand Name: UNKNOWN SHOULDER HUMERAL HEADS
• Type of Device: SHOULDER HUMERAL HEADS
• Manufacturer (Section D): DEPUY ORTHOPAEDICS INC US; 700 orthopaedic drive; warsaw IN 46581 0988
• Manufacturer (Section G): JTE WARSAW MFG SITE; 700 orthopaedic drive; warsaw IN 46582
• Manufacturer Contact: kara ditty-bovard ; 700 orthopaedic drive; warsaw, IN 46581-0988 ; 6107428552
• MDR Report Key: 9315972
• MDR Text Key: 182472015
• Report Number: 1818910-2019-113552
• Device Sequence Number: 1
• Product Code: HSD
• Combination Product (y/n): N
• Reporter Country Code: UK
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,literature
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 10/17/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/13/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: UNK SHOULDER HUMERAL HEAD
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/19/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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