MAUDE Adverse Event Report: ZIMMER BIOMET, INC. BIO-MOD HUM HEAD 48DIAX24MM; PROSTHESIS, SHOULDER

Model Number N/A

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

Patient Problems Nerve Damage (1979); Pain (1994); Loss of Range of Motion (2032); Numbness (2415); Tissue Breakdown (2681); Swelling/ Edema (4577)

Event Type  Injury  

Manufacturer Narrative

(b)(4).Concomitant medical devices: ref 113849 lot 415130 biomodular keeled glenoid; ref 113647 lot 864650 comprehensive stem.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: 0001825034 - 2021 - 01890; 0001825034 - 2021 - 01891.

Event Description

It was reported that the patient underwent a left shoulder replacement.Almost ten years later, the patient has reported constant pain, limited daily activities, loss of feeling in her hand, and mobility loss.She has received steroid injections for inflammation and spasms.No revision has been scheduled to date.Attempts have been made and no further information has been provided.

Manufacturer Narrative

(b)(4).This follow-up report is being submitted to relay additional information.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 the patient underwent a left shoulder replacement.Almost ten years later, the patient has reported constant pain, limited daily activities, loss of feeling in her hand, and mobility loss.She has received steroid injections for inflammation and spasms.No revision has been scheduled to date.Additionally it was reported that the muscle is detaching from the arm and device is coming up through the skin.

Manufacturer Narrative

(b)(4).This follow-up report is being submitted to relay additional information.Updated: b4, b5, g3, h2, h3, h6 reported event was confirmed by review of medical records.Device history record (dhr) was reviewed and no discrepancies related to the event were found.Root cause was unable to be determined.Medical records identified the following: no intra-op complications identified during the initial surgery.Patient stated she was having pain, limited daily activities, balance issues, range of motion issues, inability hold on to things, sleep loss, loss of feeling in her hand, neck and back issues.Patient stated she went to the er due to inflammation and spasms after receiving steroid injections.During that visit, she was told the metal was coming through her skin.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: BIO-MOD HUM HEAD 48DIAX24MM
• Type of Device: PROSTHESIS, SHOULDER
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• MDR Report Key: 12085151
• MDR Text Key: 258976102
• Report Number: 0001825034-2021-01889
• Device Sequence Number: 1
• Product Code: KWT
• Combination Product (y/n): N
• PMA/PMN Number: K030710
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,other
• Type of Report: Initial,Followup,Followup
• Report Date: 09/15/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/29/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 03/31/2021
• Device Model Number: N/A
• Device Catalogue Number: 113770
• Device Lot Number: 095790
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 09/08/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Treatment: SEE H10.
• Patient Outcome(s): Other