MAUDE Adverse Event Report: ZIMMER BIOMET, INC. B/F SHOULDER HEAD; PROSTHESIS, SHOULDER

Model Number N/A

Device Problems Migration or Expulsion of Device (1395); Metal Shedding Debris (1804)

Patient Problems Pain (1994); Loss of Range of Motion (2032); Tissue Damage (2104); Reaction (2414)

Event Type  Injury  

Manufacturer Narrative

(b)(4).Concomitant medical products: 00434811213, tm shoulder stem, 61905057; 00432604600, trabecular metalâ¿¢ glenoid component 46 mm, 61976949.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.Multiple mdr reports were filed for this event, please see associated reports: 0001822565 - 2018 - 02431, 0001822565 - 2018 - 02433.

Event Description

It was reported patient is experiencing pain, loosening, loss of range of motion, metallosis, and tissue damage six years post-implantation.No revision has been reported yet.Attempts have been made and additional information on the reported event is unavailable.

Manufacturer Narrative

(b)(4).Reported event was unable to be confirmed due to limited information received from the customer.Dhr was reviewed and no discrepancies relevant to the reported event were found.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.

Manufacturer Narrative

(b)(4).This follow-up report is being submitted to relay additional information.

Event Description

It was reported patient is experiencing polyethylene wear, debris within joint, pain, loosening, loss of range of motion, metallosis, and tissue damage six years post-implantation.No revision has been reported yet.Attempts have been made and additional information on the reported event is unavailable.

• Brand Name: B/F SHOULDER HEAD
• Type of Device: PROSTHESIS, SHOULDER
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• Manufacturer (Section G): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• Manufacturer Contact: christina arnt ; 56 e. bell dr.; warsaw, IN 46582 ; 5745273773
• MDR Report Key: 7480259
• MDR Text Key: 107135826
• Report Number: 0001822565-2018-02432
• Device Sequence Number: 1
• Product Code: KWT
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: PK103404
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 06/18/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/02/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Expiration Date: 02/28/2022
• Device Model Number: N/A
• Device Catalogue Number: 00430204627
• Device Lot Number: 61977465
• Other Device ID Number: N/A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/18/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/13/2012
• 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