MAUDE Adverse Event Report: BIOMET ORTHOPEDICS COMP RVRS SHLDR GLNSP STD 36MM; PROSTHESIS, SHOULDER

Model Number N/A

Device Problem Detachment Of Device Component (1104)

Patient Problem No Information (3190)

Event Date 04/28/2016

Event Type  Injury  

Manufacturer Narrative

(b)(4).Customer has indicated that the product will not be returned to zimmer biomet for investigation, as it has not been explanted.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.Concomitant medical product: comprehensive reverse shoulder glenosphere mini baseplate with taper adapter, catalog#: 010000589, lot#: 357480; biomet humeral tray, catalog#: 115370 lot#: 648630; biomet mini humeral stem, catalog#: 113631 lot#: 253100; biomet humeral bearing, catalog#: xl-115363 lot#: 418390.Multiple mdr reports were filed for this event, please see associated reports: 1825034-2016-04697, 1825034-2017-03463.

Event Description

Legal counsel for the patient reported that the patient underwent a shoulder revision approximately 10 weeks post-implantation due to disassociation of the taper adaptor from the baseplate.This report is based on allegations set forth in plaintiff¿s complaint and the allegations contained therein are unverified.

Manufacturer Narrative

(b)(4).Upon reassessment of the reported event, it was determined that this product did not have to do with the incident and is therefore not reportable.The initial report was forwarded in error and should be voided.

• Brand Name: COMP RVRS SHLDR GLNSP STD 36MM
• 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: 6595673
• MDR Text Key: 76128382
• Report Number: 0001825034-2017-03463
• 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: consumer
• Reporter Occupation: Attorney
• Type of Report: Initial,Followup
• Report Date: 06/14/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/26/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Model Number: N/A
• Device Catalogue Number: 115310
• Device Lot Number: 529480
• Other Device ID Number: SEE H10 NARRATIVE
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 06/13/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/28/2015
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 51 YR