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

Model Number N/A

Device Problems Device Dislodged or Dislocated (2923); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Erosion (1750); Joint Dislocation (2374); Muscle/Tendon Damage (4532)

Event Type  Injury  

Event Description

It was reported that a patient is being considered for a revision due to dislocation, bone loss, and rotator cuff issues.Attempts have been made and additional information on the reported event is unavailable at this time.

Manufacturer Narrative

(b)(4).The device will not be returned for analysis; however, an investigation of the reported event is in progress.Once the investigation is completed, a supplemental medwatch 3500a will be submitted.

Manufacturer Narrative

This follow-up report is being submitted to relay additional information.The rotator cuff is a group of muscles and tendons that surround the shoulder joint, keeping the head of humerus firmly within the shallow socket of the shoulder.Rotator cuff injuries occur most often in people who repeatedly perform overhead motions in their jobs or sports.Degenerative tears can also occur as a result of a wearing down of the tendon that occurs over time.This degeneration naturally occurs as we age.Factors that lead to degenerative tears include repetitive stress, lack of blood supply, bone spurs, and increased age.Common symptoms of a rotator cuff tear include pain at rest, pain when lifting, weakness, crepitus, and dislocation may occur.In addition, this is an oncology patient who has undergone a large tumor resection.Regarding the patient's bone loss, bone quality (density, strength & weakness of a bone) is influenced by many internal and external factors.Patients diet, or malabsorption due to different disease processes impacts the bone quality, as the body is not able to absorb the required nutrients to build or maintain bone density.Risk factors that increase a patients poor bone quality, not all inclusive; age, bmi, diet, smoking, alcohol consumption, vitamin intake, such as vitamin d, calcium, magnesium, hormone imbalance impacting the pituitary gland, growth factors, thyroidism & medication associated with treatment, steroid use along with other medications, renal diseases, dialysis, diabetes, blood disorders, trauma, fractures, bone on bone wear, surgical trauma or invasive procedures, repeated joint/bone surgeries resulting in bone loss, infections such as osteomyelitis, necrosis of the bone tissues due to disease processes and genetic history of family members with osteoarthritis or osteoporosis, as a patient¿s bone quality is impacted by many internal and external variables.In addition, this is an oncology patient who has undergone a large tumor resection.Upon reassessment of the reported event, it was determined to be not reportable.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 is available at the time of this report.

• Brand Name: UNKNOWN HUMERAL HEAD
• Type of Device: PROSTHESIS, SHOULDER
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; p.o. box 587; warsaw IN 46581
• Manufacturer (Section G): ZIMMER BIOMET, INC.; 56 e. bell drive; p.o. box 587; warsaw IN 46581
• Manufacturer Contact: jennifer rapsavage ; 56 e. bell dr.; warsaw, IN 46582 ; 5745260384
• MDR Report Key: 14930031
• MDR Text Key: 295327508
• Report Number: 0001825034-2022-01564
• Device Sequence Number: 1
• Product Code: KWS
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Distributor
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 07/14/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/06/2022
• 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
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 07/14/2022
• 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
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Sex: Female