MAUDE Adverse Event Report: BIOMET ORTHOPEDICS COMPREHENSIVE REVERSE SHOULDER HUMERAL TRAY WITH LOCKING RING 44MM; PROSTHESIS, SHOULDER

Model Number N/A

Device Problem Fracture (1260)

Patient Problems Pain (1994); No Code Available (3191)

Event Date 06/26/2017

Event Type  Injury  

Manufacturer Narrative

(b)(4).Concomitant medical products: comprehensive primary shoulder stem standard length catalog #: 113651 lot#: 639670, comprehensive reverse arcomxl humeral bearing catalog #: xl-115363 lot #: 373540.The customer has indicated that the product will not be returned to zimmer biomet for investigation, as the hospital would not allow the device to be released.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.

Event Description

It is reported that the patient underwent a shoulder arthroplasty revision due to fracture of the humeral tray less than seven (7) years post-operatively.The patient had felt a popping sensation while reaching for an item approximately one month prior to the revision procedure, and x-rays taken at a doctor's visit revealed the broken implant.During the revision procedure, there was a thirty (30) minute delay, as the surgeon had a difficult time removing the humeral tray because of the fracture, and had to remove the bearing and stem as well.However, the surgeon alleged no deficiencies against the bearing or stem.No additional patient consequences were reported.

Manufacturer Narrative

This supplemental report is being filed to relay additional information.

Manufacturer Narrative

This follow-up is report is being submitted to relay additional information.Reported event was confirmed by dhr.Review of the dhr found process deviation/product non-conformance was noted during op for (b)(4) pieces having machine lines on the taper side: which were reworked, operator failure to monitor surface finish.Which could likely be related to the reported event.Root cause was unable to be determined as the necessary information to adequately investigate the reported event was not 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.

• Brand Name: COMPREHENSIVE REVERSE SHOULDER HUMERAL TRAY WITH LOCKING RING 44MM
• Type of Device: PROSTHESIS, SHOULDER
• Manufacturer (Section D): BIOMET ORTHOPEDICS; 56 e. bell drive; warsaw IN 46582
• Manufacturer (Section G): BIOMET ORTHOPEDICS; 56 e. bell drive; warsaw IN 46582
• Manufacturer Contact: christina arnt ; 56 e. bell dr.; warsaw, IN 46582 ; 5745273773
• MDR Report Key: 6769052
• MDR Text Key: 81899986
• Report Number: 0001825034-2017-05946
• Device Sequence Number: 1
• Product Code: PAO
• 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,distri
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 01/12/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/04/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Expiration Date: 09/30/2020
• Device Model Number: N/A
• Device Catalogue Number: 115340
• Device Lot Number: 492410
• Other Device ID Number: N/A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/12/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/26/2010
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Removal/Correction Number: Z--1103-2017
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 77 YR
• Patient Weight: 73