MAUDE Adverse Event Report: BIOMET ORTHOPEDICS COMP RVSR SHLDR GLNSP +3 36MM; PROSTHESIS, SHOULDER

Model Number N/A

Device Problem Detachment Of Device Component (1104)

Patient Problem No Information (3190)

Event Date 05/24/2016

Event Type  Injury  

Manufacturer Narrative

Customer has not indicated whether or not the product will be returned to zimmer biomet for investigation.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.(b)(4).Concomitant medical product - biomet humeral tray, catalog#: 115370 lot#: 648630; biomet baseplate, catalog #: 010000589 lot # 357480; biomet mini humeral stem, catalog#: 113631 lot#: 253100; biomet humeral bearing, catalog#: xl-115363 lot#: 418390; biomet central screw, catalog#: 115395 lot# 161960; biomet fixed locking screw, catalog#: 180550 lot#: 6192920; biomet fixed locking screw, catalog#: 180551 lot#: 863450; biomet fixed locking screw, catalog#: 180552 lot#: 294240.This report is number 2 of 2 mdrs filed for the same patient (reference 0001825034-2016-04698-1).

Event Description

Legal counsel for the patient reported that the patient underwent a shoulder revision approximately four weeks post-implantation due to the glenosphere taper disassociating from the glenoid 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.This report was forwarded in error and should be voided.

• Brand Name: COMP RVSR SHLDR GLNSP +3 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: 6596207
• MDR Text Key: 76126061
• Report Number: 0001825034-2017-03466
• Device Sequence Number: 1
• Product Code: HSD
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: PN/A
• 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: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: 115313
• Device Lot Number: 201430
• Other Device ID Number: SEE H10 NARRATIVE
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 06/13/2017
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 11/30/2015
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 51 YR