MAUDE Adverse Event Report: ZIMMER BIOMET, INC. COMPR 8MM HUM FRACT STEM PPS; PROSTHESIS, SHOULDER

Catalog Number	12113558
Medical Device Problem Code	Loosening of Implant Not Related to Bone-Ingrowth (4002)
Health Effect - Clinical Codes	Pain (1994); Loss of Range of Motion (2032); Muscle/Tendon Damage (4532); Aseptic loosening (4883)
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that a patient underwent a right shoulder hemiarthroplasty due to humeral neck fracture.The patient is requesting product identification to schedule revision due to pain and limited range of motion.Patient states additional radiology reports provide findings of a complete tear of the tendon and suspicion of loosening.Attempts have been made and no further information has been provided.
Additional Manufacturer Narrative
(b)(4).D10: item#: 118001, versa-dial/comp ti std taper, lot#: j7629976.Item#: 113057, versa-dial 50x27x50 hum head, lot#: j7501632.G2: foreign - event occurred in malaysia.H6: proposed component code - mechanical (g04) - stem.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 8MM HUM FRACT STEM PPS
• 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: 25203770
• Report Number: 0001825034-2026-01336
• Device Sequence Number: 18666059
• Product Code: HSD
• UDI-Device Identifier: 00880304591547
• UDI-Public: (01)00880304591547(17)340322(10)66511856
• Combination Product (Y/N): N
• Initial Reporter Country: MY
• PMA/510(K) Number: K193038
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2026
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Consumer,Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 05/18/2026

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: 12113558
• Device Lot Number: 66511856
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/20/2026
• Initial Report FDA Received Date: 05/18/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 03/22/2024
• 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
• Concomitant Medical Products and Therapy/Usage Dates: SEE H11 NARRATIVE.
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Male
• Patient Weight: 36 KG