MAUDE Adverse Event Report: Zimmer Biomet, Inc. ZB 12/14 COCR FEMORAL HEADS; Prosthesis, Hip

Catalog Number	802202801
Medical Device Problem Code	Device Dislodged or Dislocated (2923)
Health Effect - Clinical Code	Joint Dislocation (2374)
Date of Event	09/23/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the patient underwent revision surgery due to dislocation 5 days after the initial hip procedure.It was reported that no further information is available.
Additional Manufacturer Narrative
(b)(4).G2: foreign - event occurred in new zealand.Proposed component code: mechanical (g04) - head.D11: cat # p0463050, lot 0001892190, item name: avan cmntd shell ss 50mm, cat # 30.00.49-100, lot 3235771, item name: stem ms-30 10 polished.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: ZB 12/14 COCR FEMORAL HEADS
• Common Device Name: Prosthesis, Hip
• 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 ; +1(574)526-0384
• MDR Report Key: 50945107
• Report Number: 0001822565-2026-03299
• Device Sequence Number: 15827387
• Product Code: LPH
• UDI-Device Identifier: 00889024498778
• Combination Product (Y/N): N
• Initial Reporter Country: NZ
• PMA/510(K) Number: K183457
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2026
• Device Explanted Year: 2026
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 09/28/2026

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: 802202801
• Device Lot Number: 3014512
• 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: 09/24/2026
• Initial Report FDA Received Date: 09/30/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: See H11 Narrative.
• Outcome Attributed to Adverse Event: Required Intervention; Hospitalization
• Patient Sex: Unknown