MAUDE Adverse Event Report: DEPUY IRELAND - 9616671 GLOBAL UNITE STD STEM SZ 14; GLOBAL UNITE IMPLANTS : SHOULDER HUMERAL STEMS

Model Number 1100-14-100

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

Patient Problems Edema (1820); Muscular Rigidity (1968); Pain (1994); No Code Available (3191)

Event Date 01/05/2016

Event Type  Injury  

Manufacturer Narrative

(b)(4).If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

Event Description

On (b)(6) 2015: patient underwent a right tsa with a depuy implant-global unite secondary to arthritis and mild posterior subluxation.No intraoperative complications noted.Cement manufacturer is unknown.On (b)(6) 2015: patient seen in office secondary to swelling and pain.The doctor also reported his ultrasounds ¿showed some clots in upper arm veins¿ and was treated with aspirin.No further interventions provided or indicated.He was also diagnosed with a right ruptured rotator cuff and was treated with a lidocaine injection and kenalog injection.On (b)(6) 2015: the patient was seen in office secondary to swelling and pain.Patient reports appointment with pa in his family physician¿s office suspects phlebitis and not a blood clot.Patient treated with full aspirin daily.Patient also diagnosed with bursitis of right elbow.And received aspiration of the right elbow with removal of 25-30 cc of fluid.On (b)(6) 2015: patient was seen in office due to swelling in right hand and arm; with 1 to 2+ pitting edema in the back of his hand and is interfering with the ability to open and close his hand.Based on this information, the patient was diagnosed with lymphedema and referred out.On (b)(6) 2016: patient was seen in office for follow-up due to pain and stiffness.No treatment prescribed.Pmh: osteoarthritis, allergy to penicillin.

Manufacturer Narrative

Product complaint # : (b)(4).Investigation summary : no device associated with this report was received for examination.A worldwide complaint database search found no other related reported incidents against the provided product code/lot number combination since release for distribution.Based on previous investigations, this complication of joint replacement is unlikely to have been the result of a device failing to meet required specifications.The information received will be retained for potential series investigations if triggered by trend analysis, post market surveillance, or other events within the quality system.Added: h6 patient code: no code available (3191) used to capture serious injury.

• Brand Name: GLOBAL UNITE STD STEM SZ 14
• Type of Device: GLOBAL UNITE IMPLANTS : SHOULDER HUMERAL STEMS
• Manufacturer (Section D): DEPUY IRELAND - 9616671; loughbeg ringaskiddy co.; cork ; EI
• MDR Report Key: 9738407
• MDR Text Key: 184811346
• Report Number: 1818910-2020-05562
• Device Sequence Number: 1
• Product Code: HSD
• UDI-Device Identifier: 10603295004158
• UDI-Public: 10603295004158
• Combination Product (y/n): N
• PMA/PMN Number: K170748
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,literatur
• Type of Report: Initial,Followup
• Report Date: 02/03/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 1100-14-100
• Device Catalogue Number: 110014100
• Device Lot Number: 8047261
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 02/03/2020
• Initial Date FDA Received: 02/21/2020
• Supplement Dates Manufacturer Received: 03/23/2020
• Supplement Dates FDA Received: 03/24/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 82 YR
• Patient Weight: 111