MAUDE Adverse Event Report: ZIMMER BIOMET, INC. OFFSET MODULAR HUMERAL HEAD 19 MM HEAD HEIGHT 52 MM SPHERICAL HEAD DIAMETER; PROSTHESIS, SHOULDER/EXTREMITY

Model Number N/A

Device Problem Unstable (1667)

Patient Problem Joint Laxity (4526)

Event Type  Injury  

Manufacturer Narrative

(b)(4).Multiple mdr reports were filed for this event, please see associated reports: 0001822565-2021-00920, 0001822565-2021-00921.Medical products: item#: 00434211613, humeral stem 42 degrees 16 mm stem diameter 130 mm stem length; lot#: unknown; item#: 00430008200, glenoid component keeled 52 mm diameter articular surface used with blue (52 mm) instruments; lot#: unknown; item#: 47430103100, drill with stop bigliani/flatow the complete shoulder solution: lot#: unknown; item#: 00430103401, keel sponge single use only; lot#: unknown; item#: 00430103501, pressurizer sponge; lot#: unknown.Customer has indicated that the product will not be returned to zimmer biomet for investigation, product remains implanted.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.

Event Description

It was reported that patient underwent initial procedure approximately nine (9) years and five (5) months ago.It has been determined that patient will be revised due to shoulder instability due to a deficient subscapularis muscle.It was reported that the cause of the deficient is unknown.

Event Description

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

Manufacturer Narrative

(b)(4).This follow-up report is being submitted to relay additional information.No product was returned or pictures provided; visual and dimensional evaluations could not be performed.Lot identification is necessary for review of device history records; lot identification was not provided.Medical records were not provided.A definitive root cause cannot 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.

• Brand Name: OFFSET MODULAR HUMERAL HEAD 19 MM HEAD HEIGHT 52 MM SPHERICAL HEAD DIAMETER
• Type of Device: PROSTHESIS, SHOULDER/EXTREMITY
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• MDR Report Key: 11614494
• MDR Text Key: 243816611
• Report Number: 0001822565-2021-00919
• Device Sequence Number: 1
• Product Code: KWT
• Combination Product (y/n): N
• PMA/PMN Number: K103404
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,health profession
• Type of Report: Initial,Followup
• Report Date: 05/17/2021

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
• Device Catalogue Number: 00430205219
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 03/12/2021
• Initial Date FDA Received: 04/05/2021
• Supplement Dates Manufacturer Received: 05/14/2021
• Supplement Dates FDA Received: 05/18/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 52 YR