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

Device Problems Loss of or Failure to Bond (1068); Loosening of Implant Not Related to Bone-Ingrowth (4002)

Patient Problems Unspecified Infection (1930); Pain (1994); Scar Tissue (2060); Numbness (2415); Osteopenia/ Osteoporosis (2651); Patient Problem/Medical Problem (2688)

Event Date 06/26/2017

Event Type  Injury  

Manufacturer Narrative

(b)(4).Concomitant medical products: unknown tm humeral head.Unknown tm poly liner.Unknown tm base plate.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.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.Multiple mdr reports were filed for this event, please see associated reports: 0001822565-2019-03613, 0001822565-2019-03618, 0001822565-2019-03619.Device location unknown.

Event Description

It was reported that the patient underwent revision of a left total shoulder arthroplasty subsequently, the patient was revised due to pain, loosening, and alteration in sensation, rom-limited mobility, and infection approximately three (3) years, five (5) months.No additional patient consequences were reported.

Manufacturer Narrative

The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.

Event Description

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

Manufacturer Narrative

Reported event was confirmed by review of medical records.Review of the available records identified the following: subscap absent ¿ non-repairable glenoid bone extremely soft limited press fit, but inferior & superior screws obtained excellent fixation loosening concern found loose humeral component, notes significant humeral bone loss (15cm), complete loss of rotator cuff and retained bone in back of humerus.Glenoid was well fixed but removed due to concerns of instability 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 additional event information is available at the time of this report.

Manufacturer Narrative

This follow-up report is being submitted to relay additional and/or corrected information.Updated: a2, a5, b3, b4, b5, g3, g4, h2, h6, h10.Root cause remains unchanged and is 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 event information available at the time of this report.

• Brand Name: UNKNOWN TM STEM COMPONENT
• Type of Device: PROSTHESIS, SHOULDER
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• MDR Report Key: 8955251
• MDR Text Key: 156277252
• Report Number: 0001822565-2019-03616
• Device Sequence Number: 1
• Product Code: HSD
• 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,Followup,Followup
• Report Date: 09/04/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/03/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 09/02/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: SEE H10
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 46 YR
• Patient Weight: 73