MAUDE Adverse Event Report: ZIMMER BIOMET, INC. 12MM A 130MM LENGTH HUMERAL STEM; SHOULDER PROSTHESIS, REVERSE CONFIGURATION/EXTREMITIES

Model Number	00-4349-012-13
Medical Device Problem Code	Loosening of Implant Not Related to Bone-Ingrowth (4002)
Health Effect - Clinical Codes	Failure of Implant (1924); Pain (1994); Muscle Hypotonia (4531)
Date of Event	05/10/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).Multiple mdr reports were filed for this event, please see associated reports: 0001822565-2022-02669, 0001822565-2022-02670, 0001822565-2022-02671, 0001822565-2022-02672, 0001822565-2022-02673.Concomitant medical products: item#: 00434903611, 36mm a glenosphere; lot#: 62234748.Item#: 00834902502, tm rvs base plt 25mm post +2; lot#: 62274777.Item#: unknown, unknown screw length 36; lot#: unknown.Item#: unknown, unknown screw length 42; lot#: unknown.Item#: unknown, unknown poly; lot#: unknown.Customer has indicated that the product will not be returned to zimmer biomet for investigation, as the product location is unknown.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 a patient underwent a third revision surgery of their shoulder approximately six (6) years and three (3) month after their second revision surgery.The patient was revised due to pain, radiolucency, and loosening.The patient continues to display atrophy of the surrounding muscles.There were no other additional complications reported at this time.
Event or Problem Description
No further event information available at the time of this report.
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: 0001822565-2022-02670-1, 0001822565-2022-02669-1, 0001822565-2022-02671-1, 0001822565-2022-02672-1, 0001822565-2022-02673-1.Component codes: mechanical (g04)- stem.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.Study reports were provided and reviewed by a health care professional.Review of the available records identified the following: pain noted beginning at on (b)(6) 2015 visit.Deltoid atrophy noted beginning at on (b)(6) 2015 visit.On (b)(6) 2018 visit noted anteroposterior and axillary xray: tricep calcification and humeral radiolucency; no planned intervention at this time.On (b)(6) 2021: revision of right total shoulder due to mechanical loosening & study complete due to device removal.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: 12MM A 130MM LENGTH HUMERAL STEM
• Common Device Name: SHOULDER PROSTHESIS, REVERSE CONFIGURATION/EXTREMITIES
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 1800 w. center st.; warsaw IN 46580
• Manufacturer (Section G): ZIMMER BIOMET, INC.; 1800 w. center st.; warsaw IN 46580
• Manufacturer Contact: jennifer rapsavage ; 56 e. bell dr.; warsaw, IN 46582 ; 5745260384
• MDR Report Key: 15422285
• Report Number: 0001822565-2022-02668
• Device Sequence Number: 19469064
• Product Code: HSD
• UDI-Device Identifier: 00889024268951
• UDI-Public: (01)00889024268951(17)230131(10)62248463
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: K130661
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2014
• Device Explanted Year: 2021
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Study,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 10/25/2022

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: 01/31/2023
• Device Model Number: 00-4349-012-13
• Device Catalogue Number: 00434901213
• Device Lot Number: 62248463
• 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: 08/18/2022
• Supplement Date Received by Manufacturer: 09/28/2022
• Initial Report FDA Received Date: 09/14/2022
• Supplement Report FDA Received Date: 10/25/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 01/16/2013
• 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
• Concomitant Medical Products and Therapy/Usage Dates: SEE H10 NARRATIVE.
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Sex: Male
• Patient Weight: 78 KG
• Patient Race: White