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

Catalog Number 115382

Device Problem Fracture (1260)

Patient Problem No Information (3190)

Event Type  Injury  

Manufacturer Narrative

(b)(4).Concomitant medical products - comprehensive reverse shoulder glenoid baseplate cat#: 115330 lot#: 061710, comprehensive primary stem cat#: 113647 lot#: 726560, comprehensive reverse humeral ti tray cat#: 115340 lot#: 541900, humeral bearing cat#: xl-115363 lot#: 778020, versa-dial/comp ti taper cat#: 118001 lot#: 456370, comprehensive reverse shoulder glenosphere cat#: 115310 lot#: 823240, comprehensive locking screw cat#: 180503 lot#: 988300, comprehensive locking screw cat#: 180501 lot#: 153550, comprehensive reverse fixed locking screw cat#: 180500 lot#: 153540.The device will not be returned for analysis [remains implanted]; however, an investigation of the reported event is in progress.Once the investigation is completed, a supplemental medwatch 3500a will be submitted.Multiple mdr reports were filed for this event, please see associated reports: 1825034-2017-02018.

Event Description

It was reported that a patient underwent an initial shoulder procedure.Approximately 4.5 years subsequent, the central baseplate screw was noted to have broken and baseplate has loosened.No revision has been scheduled.No further information is available.

Manufacturer Narrative

This follow-up report is being submitted to relay additional information.Reported event was confirmed by review of x-rays provided.X-rays show: broken central screw, loose glenoid component, which may have apparently rotated anteriorly, fracture of the acromion, multiple posterior right rib fractures, and generalized osteopenia.Fractures of the acromion and multiple posterior right-sided rib fractures are consistent with a traumatic event, which may have contributed to the reported event of fractured central screw.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.

Event Description

It was reported that a patient underwent an initial shoulder procedure.Approximately 4.5 years subsequent, the central baseplate screw was noted to have broken and baseplate has loosened.No revision has been scheduled.No further information is available.X-rays indicate fractured ribs and acromion, which are consistent with trauma.

• Brand Name: COMPREHENSIVE REVERSE CENTRAL SCREW
• 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: 6436667
• MDR Text Key: 70934166
• Report Number: 0001825034-2017-02019
• 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
• Report Date: 10/20/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/27/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Expiration Date: 03/31/2011
• Device Catalogue Number: 115382
• Device Lot Number: 193940
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/20/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/23/2011
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Weight: 88