MAUDE Adverse Event Report: ZIMMER BIOMET, INC. COMPREHENSIVE REVERSE HUMERAL TRAY WITH LOCKING RING; PROSTHESIS, SHOULDER

Model Number N/A

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

Patient Problem Blood Loss (2597)

Event Date 10/20/2010

Event Type  Injury  

Manufacturer Narrative

(b)(4).Product code- phx.Concomitant medical products: xl-115364 arcom xl 44-36 std +3 hmrl brg 990150; 113634 comp primary stem 14mm mini 145080; 115313 comp rvsr shldr glnsp +3 36mm 302660; 115330 comp rvrs shdr glen bsplt +ha 524640; 180503 comp locking screw 4.75x30mm 402230; 180510 comp non-lckng screw 4.75x30mm 448060; 115383 comp rvs cntrl scr 6.5x35mm st 492280; 118001 versa-dial/comp ti std taper 201450; 180507 comp non-lckng screw 4.75x15mm 319810; 180501 comp locking screw 4.75x20mm 905410.The complaint is confirmed based on the surgical operative notes that was provided.Review of the device history records identified no related deviations or anomalies.A root cause cannot be determined based on the information provided.If any further information is found which would change or alter any conclusions or information, a supplemental will be filed accordingly.Zimmer biomet will continue to monitor for trends.Multiple mdr reports were filed for this event, please see associated reports: 0001825034-2018-05461, 0001825034-2018-05463, 0001825034-2018-05467, 0001825034-2018-05469.

Event Description

It was reported that patient experienced 750-800 ml of blood loss during the left shoulder primary surgery.The patient received a platelet gel injection at the end of the surgery.No additional patient consequences were reported.No other additional information is available.

• Brand Name: COMPREHENSIVE REVERSE HUMERAL TRAY WITH LOCKING RING
• Type of Device: PROSTHESIS, SHOULDER
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• Manufacturer (Section G): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• Manufacturer Contact: christina arnt ; 56 e. bell dr.; warsaw, IN 46582 ; 5745273773
• MDR Report Key: 7757873
• MDR Text Key: 116292029
• Report Number: 0001825034-2018-05466
• Device Sequence Number: 1
• Product Code: KWS
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: PK080642
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,consum
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 08/07/2018

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 Expiration Date: 09/30/2020
• Device Model Number: N/A
• Device Catalogue Number: 115340
• Device Lot Number: 367310
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 07/12/2018
• Initial Date FDA Received: 08/07/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/19/2010
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 82 YR