MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH ALUMINA V40-FEMORAL HEAD 28MM, +4MM NK; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/CERAMIC/POLYMER, CEMENTED OR NON-POROUS

Model Number	6565-0-228
Medical Device Problem Code	Noise, Audible (3273)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	02/20/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Review of the device history records indicate devices were manufactured and accepted into final stock with no relevant reported discrepancies.There have been no other similar events for the lot referenced.It was noted that the device is not available for evaluation.Should additional information become available, it will be provided in a supplemental report upon completion of the investigation.
Event or Problem Description
While conversing with a surgeon regarding a patient with an alleged knee construct with squeaking, the surgeon sent the following message: "just received the implant stickers of the right hip replacement of the patient with the squeaking.She does have a ceramic on ceramic hip replacement which could be the source of the squeaking." implant stickers of the hip, implanted in 2005, are provided.

• Brand Name: ALUMINA V40-FEMORAL HEAD 28MM, +4MM NK
• Common Device Name: PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/CERAMIC/POLYMER, CEMENTED OR NON-POROUS
• Manufacturer (Section D): STRYKER ORTHOPAEDICS-MAHWAH; 325 corporate drive; mahwah NJ 07430
• MDR Report Key: 9857603
• Report Number: 0002249697-2020-00561
• Device Sequence Number: 2611909
• Product Code: LZO
• UDI-Device Identifier: 04546540390493
• UDI-Public: 04546540390493
• Combination Product (Y/N): N
• Initial Reporter State: MA
• Initial Reporter Country: US
• PMA/510(K) Number: K023901
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2005
• Reporter Type: Manufacturer
• Report Source: health professional,other
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 03/19/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 01/31/2010
• Device Model Number: 6565-0-228
• Device Catalogue Number: 6565-0-228
• Device Lot Number: 11909701
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 02/20/2020
• Initial Report FDA Received Date: 03/19/2020
• 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: 59 YR