MAUDE Adverse Event Report: ZIMMER BIOMET, INC. 15MM POST LENGTH BASE PLATE; PROSTHESIS, SHOULDER

Catalog Number	00434901500
Medical Device Problem Codes	Device Dislodged or Dislocated (2923); Loosening of Implant Not Related to Bone-Ingrowth (4002)
Health Effect - Clinical Codes	Failure of Implant (1924); Pain (1994)
Date of Event	04/04/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).G2: foreign: japan.Customer has indicated that the product will not be returned to zimmer biomet for investigation, as the device remains implanted.The investigation is in process.Once the investigation has been completed, a follow-up mdr 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.
Event or Problem Description
It was reported that the patient underwent a left shoulder arthroplasty seven years back.The patient is being considered for a pmi product due to pain and loosening.No revision procedure has been reported to date and no additional patient consequences were reported.
Additional Manufacturer Narrative
(b)(4).This follow-up report is being submitted to relay additional information.The following sections were updated/corrected: b4; b5; d2; g1; g3; g6; h1; h2; h3; h6.B3 - event date - unknown day in march 2025.The reported event is confirmed.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 not provided.A definitive root cause cannot be determined.If any further information is found that 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
It was additionally reported that the patient's tmr has a tendency to dislocate since a few years prior to the revision procedure and the pain started approximately one month prior to the revision procedure.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional information.The following sections were updated: b3, b4, d2, d6, g3, g6, h1, h2, h4, h11.The following sections were corrected: b2, b5, d1, d4, g4, h6.D10: cat: 01.04223.036, lot: 2937875 invers/revers scr syst 4.5-36.Cat: 01.04223.036, lot: 2823876 invers/revers scr syst 4.5-36.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 was revised seven years post-initial implantation due to pain and loosening.No additional patient consequences were reported.

• Brand Name: 15MM POST LENGTH BASE PLATE
• Common Device Name: PROSTHESIS, SHOULDER
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 1800 w. center st.; warsaw IN 46580
• 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: 21864457
• Report Number: 0001822565-2025-01047
• Device Sequence Number: 4721212
• Product Code: KWS
• UDI-Device Identifier: 00889024268999
• UDI-Public: (01)00889024268999(17)271130(10)63799890
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K121543
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Device Explanted Year: 2025
• 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): 10/31/2025

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 Catalogue Number: 00434901500
• Device Lot Number: 63799890
• 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: 04/09/2025
• Supplement Date Received by Manufacturer: 04/24/2025; 10/23/2025
• Initial Report FDA Received Date: 04/18/2025
• Supplement Report FDA Received Date: 05/02/2025; 10/31/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/17/2017
• 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 H11 NARRATIVE.; UNKNOWN SCREW (X2).
• Outcome Attributed to Adverse Event: Required Intervention; Hospitalization; Other
• Patient Sex: Unknown