MAUDE Adverse Event Report: ZIMMER BIOMET, INC. BIO-MOD 44X17MM HD 4MM OFFSET; PROSTHESIS, SHOULDER, SEMI-CONSTRAINED, METAL/POLYMER CEMENTED/EXTREMITIES

Model Number	113921
Medical Device Problem Code	Loosening of Implant Not Related to Bone-Ingrowth (4002)
Health Effect - Clinical Codes	Failure of Implant (1924); Joint Dislocation (2374); Muscle/Tendon Damage (4532)
Date of Event	11/08/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).Multiple mdr reports were filed for this event, please see associated reports: 0001825034-2022-02706, 0001825034-2022-02705.Medical products: item#: 113954, md hybrid glenoid base 4mm; lot#: 170890.Item#: pt-113950, pt hybrid glen post regenerex; lot#: 497560.Item#: 110027734, comp vrs implt w mi tpr adptr; lot#: 936040.Item#: 110031378, versa-dial taper adaptor 25mm; lot#: 936090.Item#: 115396, comp rvs cntrl 6.5x30mm st/rst; lot#: 989070.Item#: 180554, comp lk scr 3.5hex 4.75x35 st, lot#: 037790.Item#: 180555, comp lk scr 3.5hex 4.75x40 st, lot#: 100270.Item#: 180554, comp lk scr 3.5hex 4.75x35 st, lot#: 987960.Item#: 110030776, 40mm versa-dial glen std, lot#: 65386046.Item#: 110031399, hmrl tray std std, lot#: 65337908.Item#: 110031427, hmrl bearing 40 mm std vite, lot#: 64980844.Customer has indicated that the product will not be returned to zimmer biomet for investigation, as the hospital discarded the product.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.
Event or Problem Description
It was reported that the patient underwent a revision surgery due to a tear of the rotator cuff.Further, the patient had loosening of the glenoid component and dislocation of the polyethylene from the post implant.
Additional Manufacturer Narrative
(b)(4).This follow-up report is being submitted to relay additional information.Multiple mdr reports were filed for this event, please see associated reports: 0001825034-2022-02706-1 and 0001825034-2022-02705-1.H6: component codes: mechanical (g04) - head.Visual examination of the provided pictures identified for the bio-mod offset was verified to complaint information.No noticeable damage can be seen.Review of the device history record(s) identified no deviations or anomalies during manufacturing related to the reported event.Medical records/radiographs were provided and reviewed by a health care professional.Review of the available records identified the following assessment of imaging: a right shoulder arthroplasty is present.There is marked superior position of the humeral implant in relation to the glenoid implant consistent with a severe rotator cuff tear.Lucency along the glenoid implant fixation is consistent with implant loosening.There is no evidence of humeral implant loosening.The glenoid appears loose as noted, radiolucency is present.There is malalignment with superior position of the humeral implant in relation to the glenoid.Bone quality is osteopenic.The loosening and rotator cuff tear with migration would lead to revision to a reverse type system.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 or Problem Description
No further event information available at the time of this report.

• Brand Name: BIO-MOD 44X17MM HD 4MM OFFSET
• Common Device Name: PROSTHESIS, SHOULDER, SEMI-CONSTRAINED, METAL/POLYMER CEMENTED/EXTREMITIES
• 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: 15914640
• Report Number: 0001825034-2022-02707
• Device Sequence Number: 11861498
• Product Code: KWS
• UDI-Device Identifier: 00887868253829
• UDI-Public: (01)00887868253829(17)260316(10)286920
• Combination Product (Y/N): N
• Initial Reporter State: WA
• Initial Reporter Country: US
• PMA/510(K) Number: K992899
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2014
• Device Explanted Year: 2022
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 03/21/2023

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
• Operator of Device: Health Professional
• Device Expiration Date: 03/16/2026
• Device Model Number: 113921
• Device Catalogue Number: 113921
• Device Lot Number: 286920
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/08/2022
• Supplement Date Received by Manufacturer: 03/20/2023
• Initial Report FDA Received Date: 12/05/2022
• Supplement Report FDA Received Date: 03/21/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 03/16/2016
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention; Hospitalization
• Patient Sex: Male