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

Model Number N/A

Device Problem Fracture (1260)

Patient Problems Fall (1848); Hypersensitivity/Allergic reaction (1907); Reaction (2414)

Event Type  Injury  

Manufacturer Narrative

(b)(4).Customer has indicated that the product will not be returned to zimmer biomet for investigation, as the product location is unknown.Patient underwent revision sometime in (b)(6) 2020.Concomitant medical devices: item number: unknown, item name: unknown glenoid, lot number: unknown; item number: unknown, item name: unknown head, lot number: unknown.Multiple mdr reports were filed for this event, please see associated reports: 0001822565 - 2020 - 03772, 0001822565 - 2020 - 03773.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.

Event Description

It was reported patient underwent a left shoulder revision approximately two years post-implantation due to complications from an implant fracture and an allergic reaction to nickel and titanium.Attempts have been made and no additional information is available at this time.

Manufacturer Narrative

(b)(4) 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.H3 other text : product location unknown.

Event Description

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

• Brand Name: UNKNOWN HUMERAL STEM
• Type of Device: PROSTHESIS, SHOULDER
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• MDR Report Key: 10817280
• MDR Text Key: 215529652
• Report Number: 0001822565-2020-03771
• Device Sequence Number: 1
• Product Code: KWS
• Combination Product (y/n): N
• PMA/PMN Number: N/A
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,health professional
• Type of Report: Initial,Followup
• Report Date: 03/25/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: N/A
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 10/22/2020
• Initial Date FDA Received: 11/10/2020
• Supplement Dates Manufacturer Received: 03/24/2021
• Supplement Dates FDA Received: 03/25/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Treatment: PLEASE SEE H10 NARRATIVE.
• Patient Outcome(s): Hospitalization; Required Intervention