MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH V40 FEM HEAD ORTHINOX 26-0; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, CEMENTED

Model Number	6364-2-126
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	Thromboembolism (2654)
Date of Event	01/14/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
It was noted that the device is not available for evaluation.If additional information is received, it will be provided in a supplemental report upon completion of the investigation.The following devices were also listed in this report: centrax duration 26mm x 43mm; cat#: 6226-2-643; lot#: ln5r58; exeter v40 stem 44mm no 1; cat#: 0580-1-441; lot#: g7168281; osteonics sized cement-plug; cat#: b005-0170; lot#: 6m9431.It cannot be determined which, if any of these devices may have caused or contributed to the patient's experience.Not returned.
Event or Problem Description
On (b)(6) 2018, bha was performed.On (b)(6) 2019, patient was discharged.Light vte was confirmed.This event has no causal relationship with devices.

• Brand Name: V40 FEM HEAD ORTHINOX 26-0
• Common Device Name: PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, CEMENTED
• Manufacturer (Section D): STRYKER ORTHOPAEDICS-MAHWAH; 325 corporate drive; mahwah NJ 07430
• MDR Report Key: 9696343
• Report Number: 0002249697-2020-00266
• Device Sequence Number: 2422334
• Product Code: JDI
• UDI-Device Identifier: 04546540273314
• UDI-Public: 04546540273314
• Combination Product (Y/N): N
• Initial Reporter Country: JP
• PMA/510(K) Number: K173499
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: health professional,other
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 02/11/2020

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: Health Professional
• Device Model Number: 6364-2-126
• Device Catalogue Number: 6364-2-126
• Device Lot Number: G7449183
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 01/14/2020
• Initial Report FDA Received Date: 02/11/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Age: 78
• Patient Weight: 78