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

Model Number N/A

Device Problems Fracture (1260); Noise, Audible (3273)

Patient Problems Pain (1994); Reaction (2414)

Event Date 01/03/2017

Event Type  Injury  

Manufacturer Narrative

(b)(4).Upon review of this complaint on mar 14, 2017 the invoice was pulled which gives us a new aware date for the products that have not yet been reported.Concomitant medical devices: comprehensive screw, catalog#:180509, lot#: 852650; comprehensive reverse shoulder glenoid baseplate, catalog#:115330, lot#:524560; comprehensive reverse central screw, catalog#:115383, lot#: 256750; comprehensive non locking screw, catalog#:180509, lot#: 852620; comprehensive locking screw, catalog#:180504, lot#:029360; comprehensive locking screw, catalog#:180505, lot#: 852240; comprehensive reverse shoulder glenosphere, catalog#:115310, lot#:258260; versa dial taper, catalog#: 118001, lot#:927850.Customer has not yet indicated if the product will be returned to zimmer biomet for investigation.Once the investigation has been completed, a follow-up mdr will be submitted.Device is part of scope for previously addressed recall zfa 2016-260.Multiple mdr reports were filed for this event, please see associated reports: 0001825034-2017-01423, 0001825034-2017-02483, 0001825034-2017-02487, 0001825034-2017-02489.

Event Description

It is reported that the patient underwent right total shoulder arthroplasty revision approximately six (6) years post-operatively due to pain, implant fracture, and popping noises in the shoulder.Revision operative notes further noted thick fibrotic capsular tissue, metal-tinged fluid, small presence of metallosis, a fractured humeral tray implant with the post remaining in the humeral stem, and polyethylene wear.The stem, tray, and bearing were removed and replaced.No additional patient consequences were reported.

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) was reviewed and no discrepancies relevant to the reported event were found.Root cause was unable to be determined.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.

Manufacturer Narrative

(b)(4).The reported event is confirmed via photographs, x-rays, and operative notes received.X-ray review showed that the prosthesis was displaced and broken.Photos of the tray, stem, and bearing identified that the tray was scratched, nicked, and the taper was missing.The stem was scratched, nicked, pitted and the taper was fractured off from the tray and remains in the stem.The bearing was also worn, dented and had faded markings.Photos of devices; tray stem and bearing were received for evaluation.The root cause of the tray fracture is related to a previously addressed design deficiency related to the humeral tray component.No corrective actions, preventive actions, or field actions resulted after investigation of this event.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: PROTHESIS, 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: 6490308
• MDR Text Key: 72729237
• Report Number: 0001825034-2017-02483
• 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,health professional
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 02/07/2018

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: 09/30/2020
• Device Model Number: N/A
• Device Catalogue Number: 115340
• Device Lot Number: 415040
• Other Device ID Number: N/A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/14/2017
• Initial Date FDA Received: 04/13/2017
• Supplement Dates Manufacturer Received: 10/11/2017; 09/29/2017; 02/07/2018
• Supplement Dates FDA Received: 10/13/2017; 10/14/2017; 02/09/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/14/2010
• 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: 68 YR
• Patient Weight: 86