MAUDE Adverse Event Report: ZIMMER BIOMET, INC. UNKNOWN GLENOSPHERE; PROSTHESIS, SHOULDER

Model Number N/A

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Fatigue (1849); Hypersensitivity/Allergic reaction (1907); Pain (1994)

Event Type  Injury  

Event Description

It was reported that patient underwent a left shoulder procedure.Subsequently, the patient is requesting material composition approximately 16 years later for devices due to unknown issues that could be a reaction to the implanted devices.The patient relayed that he has toxins in his body that are coming from the parts implanted and they are affecting his body.Patient has been feeling fatigued and unmotivated and pain in his body.He had a stroke and thinks it is from the toxins he has in his body.He has been doing his own research and has self-prescribed chelation therapy.Since he has started he is now able to exercise more.No revision has been reported to date.Attempts have been made and no further information has been provided.

Manufacturer Narrative

(b)(4).Concomitant products: item #: unknown , unknown base plate, lot #: unknown; item #: unknown, unknown humeral stem, lot #: unknown; item #: unknown, unknown poly liner, lot #: unknown.Customer has indicated that the product will not be returned to zimmer biomet for investigation.The product remains implanted.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 - 2021 - 03652, 0001822565 - 2021 - 03653 , 0001822565 - 2021 - 03654.

Manufacturer Narrative

(b)(4).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 report will be filed accordingly.Zimmer biomet will continue to monitor for trends.

Event Description

No further event information available at the time of this report.

• Brand Name: UNKNOWN GLENOSPHERE
• 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: 13094797
• MDR Text Key: 282890085
• Report Number: 0001822565-2021-03655
• Device Sequence Number: 1
• Product Code: HSD
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: NI
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Consumer,Health Professional,Distributor
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 02/11/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/28/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: N/A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 02/10/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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
• Treatment: SEE H10.
• Patient Outcome(s): Other
• Patient Sex: Male
• Patient Weight: 89 KG