MAUDE Adverse Event Report: ZIMMER BIOMET, INC. COMP RVRS SHLDR GLNSP STD 36MM; PROSTHESIS, SHOULDER

Catalog Number 115310

Device Problem Unstable (1667)

Patient Problems Pain (1994); No Clinical Signs, Symptoms or Conditions (4582)

Event Type  Injury  

Event Description

It was reported that a patient began feeling movement and noise in their shoulder post-implantation.Attempts have been made and additional information on the reported event is unavailable at this time.

Manufacturer Narrative

(b)(4).Procode: phx.Medical products: cr vivacit-e 36mm brng std cat#: 110031424 lot#: 65164119.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.

Event Description

It was reported that a patient began feeling movement, noise, and pain in their shoulder post implantation.Attempts have been made and additional information on the reported event is unavailable at this time.

Manufacturer Narrative

This follow-up report is being submitted to relay additional information.H6: proposed code: mechanical (g04)- head no product was returned or pictures provided; visual and dimensional evaluations could not be performed.Review of the device history record(s) identified no deviations or anomalies during manufacturing related to the reported event.Medical records were provided and reviewed by a health care professional.Review of the available records identified the following: op report and post-op imaging notes xr shoulder 2 or 3 views- postop changes from a reverse shoulder arthroplasty.General anesthesia with interscalene block.Small amount of fibrous tissue removed.¿in order to improve exposure of the proximal humerus the previous repaired subscapularis was taken down.Loose glenosphere was evident and retrieved.Humeral tray was removed to improve exposure ¿ significant of superior wear due to malposition of the loose glenosphere.After impaction of the glenosphere into the morse taper, a small amount of rotation was identified in the glenosphere indicating the morse taper did not completely engage.The glenosphere was then removed, along with the central screw of the baseplate.Screw was replaced by a 5mm shorter screw.Glenosphere was reimpacted and demonstrated excellent engagement.Surgeon notes ¿it was felt as though this corrected the reason for failure of the original implant.¿ (central screw being seated properly).Uneventful post-operative course- discharge home.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.

Event Description

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

• Brand Name: COMP RVRS SHLDR GLNSP STD 36MM
• 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: 15095177
• MDR Text Key: 296501343
• Report Number: 0001825034-2022-01690
• Device Sequence Number: 1
• Product Code: MJT
• UDI-Device Identifier: 00880304475373
• UDI-Public: (01)00880304475373(17)320105(10)J7171789
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K080642
• 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,Followup
• Report Date: 12/29/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/25/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 115310
• Device Lot Number: J7171789
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 12/22/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/05/2022
• 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
• Treatment: SEE H10
• Patient Outcome(s): Other
• Patient Sex: Male