MAUDE Adverse Event Report: ZIMMER BIOMET, INC. BIOMET HIP SYSTEM; PROSTHESIS, HIP

Catalog Number	163662
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Stroke/CVA (1770)
Date of Event	01/12/2022
Type of Reportable Event	Death
Additional Manufacturer Narrative
(b)(4).D10: cat# 650-0327 lot# unk tprloc cocr cmtd stm t1 12.5mm.G2: foreign ¿ event occurred in the netherlands.H6: proposed component code: mechanical (g04) - head.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.
Event or Problem Description
It was reported that approximately one day post hip implantation, the patient suffered a cerebrovascular accident and passed away.Attempts have been made and no further information has been provided.
Additional Manufacturer Narrative
(b)(4).This follow-up report is being submitted to relay additional information.The following sections were updated: b7; d4; g2; g3; h2; h4; h6; h10.The following sections were corrected: e1 contact; e2; e3.Perioperative stroke is defined as a brain infarction of ischemic or hemorrhagic etiology that occurs during surgery or within 30 days after surgery.The greatest risk factors for postoperative stroke include a history of stroke, including transient ischemic attack, advanced age, anemia (hematocrit <27%), and renal dysfunction.Most perioperative strokes occur on postoperative days 2¿9.Surgeries that are at particularly high risk include emergency surgery, vascular surgery (such as carotid endarterectomy and thoracic endovascular aortic repair), and brain surgery.Since most perioperative strokes in noncardiac, non-neurological surgery are ischemic in nature, they are typically attributed to hypotension and/or low-flow states, previously undisclosed large-artery stenosis, anemia-associated tissue hypoxia, embolism (thrombus, fat, or foreign material), enhanced coagulability or thrombosis in the setting of systemic inflammation, and/or recent discontinuation of antithrombotic medications.No product was returned or pictures provided; visual and dimensional evaluations could not be performed.A review of the device history record and complaint history review will not be completed.The root cause of the reported event was determined to be unrelated to the device.Complaint is not confirmed.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 information is available at the time of this report.

• Brand Name: BIOMET HIP SYSTEM
• Common Device Name: PROSTHESIS, HIP
• 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: 24664455
• Report Number: 0001825034-2026-00677
• Device Sequence Number: 9289585
• Product Code: LPH
• UDI-Device Identifier: 00887868308277
• UDI-Public: (01)00887868308277(17)310803(10)246360
• Combination Product (Y/N): N
• Initial Reporter Country: NL
• PMA/510(K) Number: K990830
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 05/11/2026

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: 163662
• Device Lot Number: 246360
• 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: 02/26/2026
• Supplement Date Received by Manufacturer: 04/17/2026
• Initial Report FDA Received Date: 03/23/2026
• Supplement Report FDA Received Date: 05/11/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 08/03/2021
• 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: Death
• Patient Age: 86 YR
• Patient Sex: Female
• Patient Weight: 80 KG