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

Model Number N/A

Device Problems Fracture (1260); Migration or Expulsion of Device (1395)

Patient Problem No Information (3190)

Event Date 06/06/2017

Event Type  Injury  

Manufacturer Narrative

(b)(6).Medical devices: screw, catalog#:115383, lot#:552680; screw, catalog#:180500, lot#:836390; screw, catalog#:180500, lot#:669780; screw, catalog#:180501, lot#:730570; screw, catalog#: 180502, lot#:605670; glenosphere, catalog#:115320, lot#:890140; pin, catalog#:405800, lot#: 914650; drill, catalog#:405889, lot#:209110; drill, catalog#:405883, lot#:316690; taper, catalog#:118001, lot#:927470; baseplate, catalog#:115330, lot#:926700; bearing, catalog#:xl-115366, lot#:585890; stem, catalog#:113631, lot#:423170.Customer has not yet indicated if 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.

Event Description

It is reported that the patient underwent a reverse shoulder arthroplasty revision approximately six (6) years post-operatively due to fracture of the humeral tray.Attempts have been made and additional information on the reported event is unavailable at this time.

Manufacturer Narrative

This follow-up report is being submitted to relay additional information.Concomitant medical devices- screw catalog#:115383 lot#:552680, screw catalog#:180500 lot#:836390, screw catalog#:180500.Lot#:669780, screw catalog#:180501 lot#:730570, screw catalog#: 180502 lot#:605670, glenosphere catalog#:115320, lot#:890140, pin catalog#:405800 lot#: 914650, drill catalog#:405889 lot#:209110, drill catalog#:405883 lot#:316690, taper catalog#:118001 lot#:927470, baseplate catalog#:115330 lot#:926700, bearing catalog#:xl-115366 lot#:585890, stem catalog#:113631 lot#:423170, extract catalog#: 110028441 lot#:unk, multiple mdr reports were filed for this event, please see associated reports: 0001825034-2017-04588, 0001825034-2017-04590.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

It is reported that the patient underwent a reverse shoulder arthroplasty revision approximately six (6) years post-operatively due to fracture of the humeral tray.There was a reported approximate delay of thirty-five to forty-five (35-45) minutes to the procedure due to an issue with being able to remove the fracture humeral tray taper from the stem.

Manufacturer Narrative

This follow-up report is being submitted to relay additional information.Reported event was confirmed by review of provided photographs.Device history record (dhr) was reviewed and no discrepancies relevant to the reported event 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 of migration was confirmed by review of x-rays, and fracture was confirmed by photographs.Root cause remains undetermined.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
• 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: 6689104
• MDR Text Key: 79142641
• Report Number: 0001825034-2017-04550
• 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,health
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 02/09/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Expiration Date: 07/31/2021
• Device Model Number: N/A
• Device Catalogue Number: 115340
• Device Lot Number: 983880
• Other Device ID Number: N/A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 06/06/2017
• Initial Date FDA Received: 07/06/2017
• Supplement Dates Manufacturer Received: 06/06/2017; 08/23/2017; 02/09/2018
• Supplement Dates FDA Received: 07/06/2017; 08/23/2017; 02/09/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/06/2011
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 66 YR