MAUDE Adverse Event Report: BIOMET ORTHOPEDICS COMPREHENSIVE REVERSE SHOULDER 6.5MM CENTRAL SCREW; PROSTHESIS, SHOULDER

Model Number N/A

Device Problems Fracture (1260); Insufficient Information (3190)

Patient Problem No Information (3190)

Event Type  Injury  

Manufacturer Narrative

(b)(6).Product is currently not expected to return to zimmer biomet for investigation as it remains implanted.The investigation is in process.Once the investigation has been completed, a follow-up medwatch will be submitted.Multiple mdr reports were filed for this event, please see associated reports: 0001825034-2017-02643 - 02645 and 0001825034-2017-02647 - 02469; 0001825034-2016-04993 - 04996.

Event Description

Legal counsel for the patient is reporting that the patient has indicated the need for a possible revision due to their shoulder being "broke" and unspecified complications with a reverse shoulder arthroplasty approximately 4 years post-implantation.No revision has been reported to date.This report is based on allegations set forth in plaintiff¿s complaint, and the allegations contained therein are unverified.

Manufacturer Narrative

This follow-up report is being submitted to relay additional information.Concomitant medical product: comprehensive reverse shoulder glenosphere, catalog#: 115323, lot#: 555070; comprehensive reverse shoulder humeral tray, catalog#: 115370, lot#: 744590; versa-dial shoulder system comprehensive standard adaptor, catalog#: 118001, lot#: 543490; comprehensive reverse shoulder humeral bearing, catalog#: xl-115367, lot#: 970780; fixed locking screw, catalog#: 180503, lot#: 721310; fixed locking screw, catalog#: 180505, lot#: 448010; fixed locking screw, catalog#: 180501, lot#: 491850; fixed locking screw, catalog#: 180500, lot#: 404300; comprehensive shoulder primary stem, catalog#: 113653, lot#: 464950.Reported event was unable to be confirmed due to limited information received from the customer.Device history record (dhr) was reviewed and no discrepancies were found.Review of the complaint history determined that no further action(s) is/are required.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.

Manufacturer Narrative

This follow-up report is being submitted to relay additional information.Reported event was unable to be confirmed due to limited information received from the customer.Device history record (dhr) review was unable to be performed as the lot number of the device involved in the event is unknown.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 6.5MM CENTRAL SCREW
• Type of Device: PROSTHESIS, SHOULDER
• Manufacturer (Section D): BIOMET ORTHOPEDICS; 56 e. bell drive; warsaw IN 46582
• MDR Report Key: 6507354
• MDR Text Key: 73253510
• Report Number: 0001825034-2017-02643
• Device Sequence Number: 1
• Product Code: PAO
• Combination Product (y/n): N
• PMA/PMN Number: PK080642
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer
• Type of Report: Initial,Followup,Followup
• Report Date: 10/11/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/20/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Expiration Date: 12/31/2018
• Device Model Number: N/A
• Device Catalogue Number: 115385
• Device Lot Number: 732670
• Other Device ID Number: N/A
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 09/14/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Patient Outcome(s): Other