MAUDE Adverse Event Report: ZIMMER BIOMET, INC. COMPR SRS SEAS HMRL HEAD 40X15; PROSTHESIS, SHOULDER, NON-CONSTRAINED, METAL/POLYMER CEMENTED

Catalog Number	211256
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Post Operative Wound Infection (2446)
Date of Event	06/25/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that an initial left total humeral arthroplasty was performed.The patient subsequently developed a wound-healing complication.Approximately two and a half months after the index procedure, debridement of soft tissue and antibiotic therapy were performed.All implants remained implanted.At one-year follow-up, the patient reported being satisfied.Due diligence is complete for this complaint; it was reported that no further information is available, and to date no additional information or product has been received.
Additional Manufacturer Narrative
(b)(4).Multiple mdr reports were filed for this event.Associated reports are available for the applicable concomitant products in the d10 narrative below.D10: concomitant medical products, part (lot): 110029826 (656680), 211223 (66287804), 211224 (66626556), 211229 (726590).Associated product information: unknown cement (unknown).G2: foreign - event occurred in denmark.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.

• Brand Name: COMPR SRS SEAS HMRL HEAD 40X15
• Common Device Name: PROSTHESIS, SHOULDER, NON-CONSTRAINED, METAL/POLYMER CEMENTED
• 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: 25258099
• Report Number: 0001825034-2026-01457
• Device Sequence Number: 20191610
• Product Code: KWT
• UDI-Device Identifier: 00880304507814
• UDI-Public: (01)00880304507814(17)320201(10)103210
• Combination Product (Y/N): N
• Initial Reporter Country: DA
• PMA/510(K) Number: K111746
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2025
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Study,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 05/22/2026

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: 211256
• Device Lot Number: 103210
• 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: 04/28/2026
• Initial Report FDA Received Date: 05/22/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 02/01/2022
• 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.
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Age: 76 YR
• Patient Sex: Female
• Patient Weight: 82 KG