MAUDE Adverse Event Report: ZIMMER BIOMET, INC. COMP RVS TRAY CO 44MM; PROSTHESIS, SHOULDER

Catalog Number	115370
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Pain (1994); Discomfort (2330)
Date of Event	11/25/2019
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported a patient was treated with a cortisone injection and pt 9 months post implantation due to shoulder stiffness and pain.All implants remain implanted.No revision is scheduled.Attempts have been made and no further information has been provided.
Additional Manufacturer Narrative
(b)(4).D10: e1 44-36 std hmrl brng cat# ep-115393 lot#: 719450.Compr srs prox bdy - sm 48mm cat#: 211215 lot#: 179160.Compr srs mod stem - 10x150mm cat#: 211243 lot#: 986950.Compr srs mod rgx aug - sm cat#: 211228 lot#: 005970.Compr srs mod rgx aug - sm cat#: 211228 lot#: 005950.The device will not be returned for analysis; however, an investigation of the reported event is in progress.Once the investigation is completed, a supplemental medwatch 3500a will be submitted.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional information.The following sections were updated: b4, b5, d4, g3, g6, h2, h3, h4, h6, h11 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 provided and reviewed by a health care professional.Review of the available records identified the following: 1 month postop: developed left elbow olecranon bursitis after l-shoulder surgery; resolved with cortisone injection 3 months later.Mild in severity (not calling out due to bursitis is related to elbow and not shoulder) cortisone injection administered in office, resolved symptoms by follow-up.9 months postop: patient noted persistent l-shoulder stiffness during follow-up visits, receiving pt and deltoid injections for management.Ongoing as of last office visit 2 years post op.Mild in severity.Pt prescribed for shoulder stiffness; injections given for pain management.A definitive root cause cannot be determined.The reported event is unconfirmed.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: COMP RVS TRAY CO 44MM
• Common Device Name: PROSTHESIS, SHOULDER
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; p.o. box 587; warsaw IN 46581
• 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: 23575257
• Report Number: 0001825034-2025-03664
• Device Sequence Number: 10129236
• Product Code: PHX
• UDI-Device Identifier: 00880304543201
• UDI-Public: (01)00880304543201(17)290124(10)341440
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K113069
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• 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): 04/29/2026

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?: No
• Operator of Device: Lay User/Patient
• Device Catalogue Number: 115370
• Device Lot Number: 341440
• 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: 10/30/2025
• Supplement Date Received by Manufacturer: 04/15/2026
• Initial Report FDA Received Date: 11/17/2025
• Supplement Report FDA Received Date: 04/29/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/24/2019
• 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
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: SEE H11
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 82 YR
• Patient Sex: Female