MAUDE Adverse Event Report: BIOMET ORTHOPEDICS COMPREHENSIVE REVERSE HUMERAL TRAY WITH LOCKING RING 44MM STANDARD; PROSTHESIS, SHOULDER

Model Number N/A

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

Patient Problems Fall (1848); Pain (1994); No Code Available (3191)

Event Date 05/30/2017

Event Type  Injury  

Manufacturer Narrative

(b)(4).Concomitant devices - comprehensive reverse glenoid baseplate catalog #: 115330 lot #: 680580, comprehensive reverse 36mm glenosphere catalog #: 115313 lot #: 741400, comprehensive reverse 17mm primary stem catalog #: 113657 lot #: 715500, comprehensive reverse arcom retentive humeral bearing catalog #: xl-115365 lot #: 382310, comprehensive shoulder standard taper adaptor catalog #: 118001 lot #: 037680, non-locking screw 4.75mm x 15mm catalog #: 180507 lot #: 268880, non-locking screw 4.75mm x 20mm catalog #: 180508 lot #: 436550, non-locking screw 4.75mm x 25mm catalog #: 180509 lot #: 436580, non-locking screw 4.75mm x 30mm catalog #: 180510 lot #: 436610, fixed locking screw 4.75 x 25mm catalog #: 180502 lot #: 851920, comprehensive reverse central screw 6.5mm x 40mm catalog #: 115384 lot #: 732650, comprehensive reverse steinmann pin catalog #: 405800 lot #: 974150, comprehensive reverse 3.2mm diameter drill catalog #: 405883 lot #: 419260, comprehensive reverse 2.7mm diameter drill catalog #: 405889 lot #: 125230.The customer has indicated that the product will not 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 shoulder arthroplasty revision due to an allegation that the device may be recalled.Attempts have been made to retrieve additional information, but no further information is available at this time.

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.Review of the complaint history determined that this part and lot number are associated with a recall.The recall concerns fatigue fracture of the comprehensive reverse humeral tray.Fracture has been noticed to occur around the taper tray junction.Unspecified print dimension tray thickness and radius may contribute to devise fatigue failure.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

(b)(4).Reported event was confirmed by review of medical records.A radiologist reviewed provided x-rays and noted no hardware failure and an overall fit and alignment of the implants, osteopenia, and no signs of loosening, wear, or radiolucency.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

(b)(4).

Event Description

It was reported that the patient underwent a shoulder arthroplasty revision surgery due to onset of pain following a fall.It was further reported that the patient's humeral tray trunnion had fractured as a result.No additional patient consequences were reported.

• Brand Name: COMPREHENSIVE REVERSE HUMERAL TRAY WITH LOCKING RING 44MM STANDARD
• 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: 6681310
• MDR Text Key: 78851691
• Report Number: 0001825034-2017-04432
• 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,distri
• Reporter Occupation: Physician
• Remedial Action: Recall
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 08/21/2018

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: 04/30/2019
• Device Model Number: N/A
• Device Catalogue Number: 115340
• Device Lot Number: 839150
• Other Device ID Number: N/A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 06/02/2017
• Initial Date FDA Received: 06/30/2017
• Supplement Dates Manufacturer Received: 07/20/2017; 06/06/2018; 07/24/2018
• Supplement Dates FDA Received: 07/21/2017; 08/10/2018; 08/23/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/29/2009
• 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
• Treatment: SEE H10 NARRATIVE
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 76 YR