MAUDE Adverse Event Report: ZIMMER BIOMET, INC. ZIMMER TRABECULAR METAL REVERSE SHOULDER SYSTEM VIVACIT-E POLY LINER; SHOULDER PROSTHESIS, REVERSE CONFIGURATION

Catalog Number	00435006503
Medical Device Problem Code	Positioning Failure (1158)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/23/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).D10: associated product information, part (lot): 00434901213 (66466956).00430902902 (unknown).00430902901 (unknown).G2: foreign - the event occurred in japan the product has been received by zimmer biomet and the investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.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 reported that during an arthroscopic procedure, the liner would not fully mate with the stem following impaction.The correct surgical technique was used.An alternate liner was used successfully to complete the procedure without delay.No complications, injuries, or surgical interventions were reported due to this malfunction.Attempts have been made, and no further information has been provided.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional information.The following sections were updated: b4, b5, g3, g6, h2, h3, h6, h11.Visual examination of the returned product/provided pictures identified a zimmer tm reverse shoulder retentive poly liner (lot 64737412) was returned for evaluation.As returned, product identifiers and dimensional measurements are conforming to print specifications.Visual examination found no damage or witness marks.Review of the device history record(s) identified no deviations or anomalies during manufacturing related to the reported event.A definitive root cause cannot be determined.The reported event is not confirmed.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 is available at the time of this report.

• Brand Name: ZIMMER TRABECULAR METAL REVERSE SHOULDER SYSTEM VIVACIT-E POLY LINER
• Common Device Name: SHOULDER PROSTHESIS, REVERSE CONFIGURATION
• 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: 20023697
• Report Number: 0001822565-2024-02693
• Device Sequence Number: 20673729
• Product Code: PHX
• UDI-Device Identifier: 00889024269460
• UDI-Public: (01)00889024269460(17)250817(10)64737412
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K133378
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• 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
• Report Date (Section B): 10/18/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 08/17/2025
• Device Catalogue Number: 00435006503
• Device Lot Number: 64737412
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/09/2024
• 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: 07/26/2024
• Supplement Date Received by Manufacturer: 10/17/2024
• Initial Report FDA Received Date: 08/21/2024
• Supplement Report FDA Received Date: 10/18/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/02/2020
• 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: H11
• Patient Sex: Unknown