MAUDE Adverse Event Report: ZIMMER BIOMET, INC. B/F GLENOID COMPONENT PEGGED 52 MM DIAMETER ARTICULAR SURFACE; PROSTHESIS, SHOULDER

Model Number N/A

Device Problems Material Erosion (1214); Fracture (1260); Insufficient Information (3190)

Patient Problems Erosion (1750); Pain (1994); Tissue Damage (2104); No Information (3190)

Event Date 05/29/2019

Event Type  Injury  

Manufacturer Narrative

(b)(4).Concomitant medical products: catalog # ni, unknown shoulder stem, lot # ni; catalog # ni, unknown shoulder head, lot # ni.The device will not be returned for analysis; 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: 0001822565-2018-03381, 0001822565-2018-03379.Remains implanted.

Event Description

It was reported patient underwent a shoulder arthroplasty procedure.Subsequently, patient is experiencing unknown complications.No further information is available at this time.

Manufacturer Narrative

This follow-up report is being submitted to relay additional information.Updated: reported event was unable to be confirmed as part number / lot number of device involved in the incident is unknown.Device history record (dhr) review was unable to be performed as the lot number of the device involved in the event is unknown.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

No further information available.

Manufacturer Narrative

This follow-up report is being submitted to relay additional information.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.

Event Description

It was reported the patient is experiencing increasing problems with their right total shoulder arthroplasty six year post primary implantation.The patient was diagnosed with pain secondary to rotator cuff tearing.The devices remain in good position and appear well fixed in imaging.The glenoid component exhibits signs of breakage or wearing as exhibited by lucency in imaging.Bone loss has also been noted.The patient has not been revised, but has elected for a future revision.No further information available.

Event Description

It was reported the patient is experiencing pain five years post primary shoulder and is scheduled for a future revision to convert to a reverse shoulder.No further information is available as the patient has not yet been revised.

Manufacturer Narrative

This follow-up report is being submitted to relay additional information.

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) review was unable to be performed as the lot number of the device involved in the event is unknown.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

No further information available at the time of this reporting.

Manufacturer Narrative

This follow-up report is being submitted to relay additional information.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.

Event Description

The patient has been revised to address implant fracture.The patient was bone grafted and the arm is currently immobilized.No further information has been made available at this time.

Event Description

The patient has been revised to address pain attributed to implant fracture as indicated in preoperative imaging indicating loss of joint space represented by glenoid component (erosion), lucency around glenoid component, partial tear of subscapularis, and bone loss.The patient was bone grafted and the arm is currently immobilized.No further information has been made available at this time.

Manufacturer Narrative

This follow-up report is being submitted to relay additional information.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.

Manufacturer Narrative

This follow-up report is being submitted to relay additional information.Review of provided patient medical records confirms the reported revision due to implant fracture.No device was returned for examination.Review of device history records was not possible as the necessary product/lot code combination was not provided.The investigation can draw no conclusions with the information made available.Root cause remains unknown.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

No further information is available at the time of this reporting.

• Brand Name: B/F GLENOID COMPONENT PEGGED 52 MM DIAMETER ARTICULAR SURFACE
• Type of Device: PROSTHESIS, SHOULDER
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• MDR Report Key: 7627064
• MDR Text Key: 111975732
• Report Number: 0001822565-2018-03382
• Device Sequence Number: 1
• Product Code: KWT
• Combination Product (y/n): N
• PMA/PMN Number: K103404
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date: 07/17/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/21/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: 00430008700
• Other Device ID Number: N/A
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 07/15/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Treatment: 00430205223 OFFSET HUM HEAD, LOT UNK; 00434211413 TM HUMERAL STEM, LOT UNK
• Patient Outcome(s): Hospitalization; Other; Required Intervention