MAUDE Adverse Event Report: ZIMMER BIOMET, INC. CR PROLONG 40MM BRNG STD; SHOULDER PROSTHESIS

Catalog Number	110031421
Medical Device Problem Codes	Detachment of Device or Device Component (2907); Device Dislodged or Dislocated (2923); Unintended Movement (3026)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/12/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).Customer has indicated that the product is in process of being returned to zimmer biomet for investigation.Once the investigation has been completed, a follow-up mdr will be submitted.
Event or Problem Description
It was reported that there was a revision approximately 2 months ago due to a possibility of disassociation, from a device that was implanted approximately 9 months ago.Liner was found loose in capsule and removed as well as the tray.During the revision it was noted that there was no apparent damage to glenosphere.Attempts have been made and additional information on the reported event is unavailable at this time.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional information.The following sections were updated/corrected.Updated: a1; a2; a3; a4; b7; d4; h2; h4.An investigation of the reported event is in progress.Once the investigation has been completed, a follow-up mdr will be submitted.
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 following sections were updated: b5; h3; h6; h11 the reported event could not be confirmed.Radiographs were provided and reviewed by a health care professional.Review of the available records identified the following: right shoulder reverse shoulder arthroplasty exhibits anterior subluxation of the humerus/humeral component.Close proximity of the inferior humeral tray with the glenosphere may suggest possibility of liner damage or disassociation but is not conclusive.Visual examination of the returned devices identified the bearing returned has wear on the non-working surface as well as a gouge on the working surface.The outer diameter and the locking features of the bearing are also damaged.The tray has some damage near the area where the bearing would lock in.Dimensional analysis of the product determined that the product, where measured, was conforming to print specifications.The device history record was reviewed and no discrepancies relevant to the reported event were found.A definitive root cause cannot be determined.If any further information is found 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
It was reported that the patient underwent a shoulder revision approximately 7 months post-implantation due to liner disassociation.During follow-up, liner disassociation was suspected and a revision was scheduled.Intra-operatively, the liner was found loose within the capsule and was easily removed with forceps.The tray was removed as well.The glenosphere showed no apparent damage.Trialing was performed with a +0 liner, after which a +3 liner was requested for re-implantation, and the wound was closed.Attempts have been made and no further information has been provided.

• Brand Name: CR PROLONG 40MM BRNG STD
• Common Device Name: SHOULDER PROSTHESIS
• 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: 23294158
• Report Number: 0001822565-2025-03744
• Device Sequence Number: 17365866
• Product Code: PHX
• UDI-Device Identifier: 00887868231520
• UDI-Public: (01)00887868231520(17)291003(10)66891075
• Combination Product (Y/N): N
• Initial Reporter State: CO
• Initial Reporter Country: US
• PMA/510(K) Number: K181611
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2025
• Device Explanted Year: 2025
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 03/13/2026

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: Lay User/Patient
• Device Catalogue Number: 110031421
• Device Lot Number: 66891075
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• 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: 09/17/2025
• Supplement Date Received by Manufacturer: 12/23/2025; 03/13/2026
• Initial Report FDA Received Date: 10/15/2025
• Supplement Report FDA Received Date: 01/22/2026; 03/31/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/04/2024
• 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 Age: 67 YR
• Patient Sex: Male
• Patient Weight: 95 KG