MAUDE Adverse Event Report: ZIMMER BIOMET, INC. COMPREHENSIVE PRIMARY STEM 10MM STANDARD; PROSTHESIS, SHOULDER

Model Number N/A

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

Patient Problems Nerve Damage (1979); Fracture, Arm (2351)

Event Date 02/26/2016

Event Type  Injury  

Manufacturer Narrative

(b)(4).Unique identifier (udi) #: n/a concomitant medical products: comprehensive reverse shoulder humeral tray with locking ring 44 mm standard [catalog # 115340; lot 659950]; glenoid baseplate [catalog # 115330; lot 863590]; arcomxl standard humeral bearing 44 ¿ 36 mm [catalog # xl-115363; lot 745250]; versa-dial glenosphere standard 36 mm [catalog # 115310; lot 457000]; humeral stem standard 10 mm [catalog # 113650; lot 623850]; fixed non-locking screw 4.75 3.5 hex 15 mm [catalog # 180507; lot 852390]; fixed locking screw 4.75 mm 3.5 hex 20 mm [catalog # 180501; lot 851510]; fixed locking screw 4.75 mm x 15 mm [catalog # 180500; lot 468560]; fixed locking screw 4.75 mm 3.5 hex 15 mm [catalog # 180500; lot 851320]; central screw 6.5 3.5 hex 25 mm [catalog # 115381; lot 320020]; versa-dial taper adaptor [catalog # 118001; lot 380360].The device will not be returned for analysis; however, an investigation of the reported event is in progress.Once the investigation is completed, a supplemental medwatch 3500a will be submitted.Device remains implanted.

Event Description

It was reported that a patient underwent initial right reverse shoulder arthroplasty procedure.Subsequently, the patient underwent humeral repair procedure with cabling due to right periprosthetic humerus fracture.The fracture was in 4 main fragments including butterfly fragments in the medial and lateral side, and a distal fragment.During the procedure the radial nerve was noticed to have been entangled between the bone fragments.The nerve was intact, however, weak.The procedure was completed successfully with no complications.No further information is available.

Manufacturer Narrative

Reported event was confirmed by review of medical records.Review of op notes confirmed the patient had a revision due to periprosthetic humeral fracture.The fracture was found in four fragments: 2 butterfly fragments, with the radial nerve found to be entrapped.Surgeon noted radial nerve intact, although weak.Device history record (dhr) was reviewed and no discrepancies were found.Root cause could not be determined with information available.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.

Event Description

No further event information available at the time of this report.

• Brand Name: COMPREHENSIVE PRIMARY STEM 10MM STANDARD
• Type of Device: PROSTHESIS, SHOULDER
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• MDR Report Key: 7779325
• MDR Text Key: 116995624
• Report Number: 0001825034-2018-05054
• Device Sequence Number: 1
• Product Code: MBF
• Combination Product (y/n): N
• PMA/PMN Number: PK060692
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: other
• Type of Report: Initial,Followup
• Report Date: 12/10/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/13/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 01/31/2018
• Device Model Number: N/A
• Device Catalogue Number: 113650
• Device Lot Number: 623850
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 12/10/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 74 YR