MAUDE Adverse Event Report: BIOMET ORTHOPEDICS COMPREHENSIVE PRIMARY STANDARD LENGTH SHOULDER STEM; PROSTHESIS, SHOULDER

Model Number N/A

Device Problem Difficult to Remove (1528)

Patient Problem Bone Fracture(s) (1870)

Event Date 03/03/2017

Event Type  Injury  

Manufacturer Narrative

Current information is insufficient to permit a conclusion as to the cause of the event.This report is number 2 of 2 mdrs filed for the same patient (reference 0001825034-2017-02202).(b)(6).Concomitant devices - comprehensive reverse fixed locking screw catalog #: 180500 lot #: 172740.Comprehensive reverse fixed locking screw catalog #: 180500 lot #: 645730.Comprehensive reverse fixed locking screw catalog #: 180503 lot #: 531980.Comprehensive reverse glenosphere catalog #: 115310 lot #: 179070.Comprehensive reverse glenoid baseplate catalog #: 115330 lot #: 319970.Arcom xl standard humeral bearing catalog #: xl-115363 lot #: 640710.Comprehensive reverse central screw catalog #: 115381 lot #: 532450.Versa-dial comprehensive standard taper catalog #: 118001 lot #: 739200.Comprehensive reverse humeral tray catalog #: 115340 lot #: 668610.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 during a shoulder arthroplasty revision to remove a fractured humeral tray, it was noted that the taper of the humeral tray had cold-welded and remained stuck to the humeral stem.As a result, the surgeon tried to remove the humeral stem with great difficulty.The humeral stem was able to be removed after a surgical delay of an hour and the patient's greater tuberosity and lesser tuberosity of the humerus was noted to be fractured.No additional patient consequences were reported and the surgery was completed without further issue.

Manufacturer Narrative

This follow-up report is being submitted to relay additional information.Reported event was confirmed by review of medical records.It is noted by the surgeon that there were multiple attempts to remove the taper from the stem over a period of approximately one hour.After this proved unsuccessful, the decision was made to explant the stem.The operative notes indicate that it was at this stage of the procedure that the patient experienced a bone fracture.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.

• Brand Name: COMPREHENSIVE PRIMARY STANDARD LENGTH SHOULDER STEM
• 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: 6497102
• MDR Text Key: 72919824
• Report Number: 0001825034-2017-02578
• Device Sequence Number: 1
• Product Code: MBF
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: PK060716
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,distri
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 08/28/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/17/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Expiration Date: 11/10/2018
• Device Model Number: N/A
• Device Catalogue Number: 113651
• Device Lot Number: 333290
• Other Device ID Number: N/A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/25/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/10/2008
• 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): Hospitalization; Required Intervention
• Patient Age: 80 YR
• Patient Weight: 73