MAUDE Adverse Event Report: ZIMMER BIOMET, INC. COMPREHENSIVE REVERSE 25MM BSPLT HA+ADPTR; PROSTHESIS, SHOULDER

Catalog Number 010000589

Device Problem Detachment of Device or Device Component (2907)

Patient Problem Insufficient Information (4580)

Event Date 03/22/2024

Event Type  Injury  

Event Description

It was reported that a patient underwent an initial left total shoulder arthroplasty.Subsequently, two (2) years and two (2) months post-implantation, the patient underwent revision surgery due to disassociation of the taper adapter from the glenoid baseplate.Due diligence is in progress for this event; to date no further information has been reported.

Manufacturer Narrative

(b)(4).D10: medical product: comp rvrs shldr glnsp std 41mm: catalog#115320, lot#208890; unknown comprehensive reverse humeral tray: catalog#ni, lot#ni; unknown comprehensive reverse humeral bearing: catalog#ni, lot#ni; unknown comprehensive reverse humeral stem: catalog#ni, lot#ni.G2: foreign: germany.Diligence is in process to determine whether the product is available for evaluation.The investigation is in progress.Upon receipt of additional information or completion of the investigation, a follow-up mdr will be submitted.

Event Description

T was reported that a patient underwent an initial left total shoulder arthroplasty.Subsequently, two (2) years and one (1) month post-implantation, the patient underwent revision surgery due to disassociation of the taper adapter from the glenoid baseplate.Due diligence is complete as multiple attempts have been made however all available information has been reported.

Manufacturer Narrative

D10: medical product: comp rvrs shldr glnsp std 41mm: catalog#115320, lot#208890; comp rvs tray co 44mm: catalog#115370, lot#458320; arcom xl 44-41 rtnv +3 hmrl br: catalog#xl-115368, lot#876310; compr srs mod stem - 8x100mm: catalog#211236, lot#023120; compr srs mod rgx aug - sm: catalog#211228, lot#726190; compr srs tumor bdy - 71mm: catalog#211223, lot#641570; comp lk scr 3.5hex 4.75x30 st: catalog#180553, lot#344950; comp rvs cntrl 6.5x20mm st/rst: catalog#115394, lot#105010; comp.Rev shldr 9 in steinmann: catalog#405800, lot#557830 the investigation is in process.Upon completion of the investigation, a follow-up mdr will be submitted.

Manufacturer Narrative

This follow-up report is being submitted to relay additional information.Visual and dimensional evaluations of the product could not be performed as no product was returned nor were pictures provided.Device history record was reviewed and no discrepancies related to the reported event were found.Radiographs were provided and reviewed by a health care professional.Review of the available records identified the following: there is a reverse-type left shoulder arthroplasty with a long-stem proximal humeral replacement implant.The distal implant is not included.The glenosphere has disassociated from the baseplate.There is no fracture or evidence of implant loosening.Bone quality is osteopenic.Root cause was unable to be determined.Reported event was confirmed by review of provided radiographs.If any further information is found which would change or alter any conclusions or information, a supplemental report will be filed accordingly.Zimmer biomet will continue to monitor for trends.

Event Description

No further event information at time of this report.

• Brand Name: COMPREHENSIVE REVERSE 25MM BSPLT HA+ADPTR
• 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: 19132741
• MDR Text Key: 340458826
• Report Number: 0001825034-2024-01044
• Device Sequence Number: 1
• Product Code: PHX
• UDI-Device Identifier: 00880304532465
• UDI-Public: (01)00880304532465(17)310506(10)505100
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: K193373
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 04/24/2024

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 Catalogue Number: 010000589
• Device Lot Number: 505100
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 03/25/2024
• Initial Date FDA Received: 04/18/2024
• Supplement Dates Manufacturer Received: 04/22/2024
• Supplement Dates FDA Received: 04/25/2024
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 05/06/2021
• 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 H11 NARRATIVE; SEE H11 NARRATIVE
• Patient Outcome(s): Required Intervention; Hospitalization
• Patient Sex: Female