MAUDE Adverse Event Report: ZIMMER BIOMET, INC. COMP NLK SCR 3.5HEX 4.75X20 ST; PROSTHESIS, SHOULDER

Model Number	N/A
Medical Device Problem Codes	Material Erosion (1214); Loosening of Implant Not Related to Bone-Ingrowth (4002)
Health Effect - Clinical Codes	Failure of Implant (1924); Metal Related Pathology (4530)
Date of Event	03/24/2021
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the patient underwent a reverse shoulder arthroplasty on an unknown date.Subsequently, in an unknown timeframe post-implantation, the patient was revised due to aseptic loosening with periprosthetic osteolysis, wear of the poly component, and metallosis.Attempts have been made and no further information has been provided.
Additional Manufacturer Narrative
(b)(4).Customer has indicated that the product will not be returned to zimmer biomet for investigation, as the product is getting pathology tested.The investigation is in process.Once the investigation has been completed, a follow-up mir will be submitted.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.Device product code: phx.Concomitant products: part# 115370, lot 944340.Part# xl-115363; lot# 798550.Part# pt-113950; lot# 682270.Part# 113648; lot# 647510.Part# 118001; lot# 384530.Part# 115310; lot# 042090.Part# 180560; lot# 114970.Part# 180553; lot# 687720.Part# 180553; lot# 093880.Part# 115398; lot# 714870.Part# 115330; lot# 157840.Report source: (b)(6).Multiple mdr reports were filed for this event, please see associated reports: 0001825034 - 2022 - 00424, 0001825034 - 2022 - 00425, 0001825034 - 2022 - 00426, 0001825034 - 2022 - 00427, 0001825034 - 2022 - 00428, 0001825034 - 2022 - 00429, 0001825034 - 2022 - 00430, 0001825034 - 2022 - 00432, 0001825034 - 2022 - 00433, 0001825034 - 2022 - 00434, 0001825034 - 2022 - 00435.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional information.Upon reassessment of the reported event, it was determined to be not reportable.Metallosis caused between the articulation of the tray and glenosphere is a secondary failure of the poly wear.Loosening is also a secondary failure of poly wear.The initial report was forwarded in error and should be voided.If any further information 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 or Problem Description
No further event information available at the time of this report.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional information.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.If any further information 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 or Problem Description
No further event information available at the time of this report.

• Brand Name: COMP NLK SCR 3.5HEX 4.75X20 ST
• Common Device Name: PROSTHESIS, SHOULDER
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• Manufacturer (Section G): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• Manufacturer Contact: christina arnt ; 56 e. bell dr.; warsaw, IN 46582 ; 5745273773
• MDR Report Key: 13653525
• Report Number: 0001825034-2022-00431
• Device Sequence Number: 11985419
• Product Code: PHX
• UDI-Device Identifier: 00880304555396
• UDI-Public: (01)00880304555396(17)270504(10)330140
• Combination Product (Y/N): N
• Initial Reporter Country: SP
• PMA/510(K) Number: K130390
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Device Explanted Year: 2021
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 06/10/2022

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 Model Number: N/A
• Device Catalogue Number: 180558
• Device Lot Number: 330140
• 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: 02/07/2022
• Supplement Date Received by Manufacturer: 03/15/2022; 06/07/2022
• Initial Report FDA Received Date: 03/02/2022
• Supplement Report FDA Received Date: 04/11/2022; 06/10/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 05/04/2017
• 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: Required Intervention; Hospitalization
• Patient Age: 46 YR
• Patient Sex: Female
• Patient Weight: 48 KG