MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH EXETER V40 STEM 37.5MM NO 2; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, CEMENTED

Model Number	0580-1-372
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	09/20/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
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
It was reported by the sales rep that a curve metal object was detected through post-op x-ray and ct scan after patient went through a bipolar hemiarthroplasty surgery.The object is locating near to stryker uhr bipolar component and femoral metal head.Patient does not have any complication.The object might affect the operated joint articulation in future.Surgical team is observing the patient for next 3 months.Date of the bipolar hemiarthroplasty surgery: (b)(6) 2020.As per sales confirmation, hospital is not able to provide the additional information such as x-ray photo, due to pdpa in the country.

• Brand Name: EXETER V40 STEM 37.5MM NO 2
• 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: 10703940
• Report Number: 0002249697-2020-02182
• Device Sequence Number: 3733143
• Product Code: JDI
• UDI-Device Identifier: 04546540153265
• UDI-Public: 04546540153265
• Combination Product (Y/N): N
• Initial Reporter Country: SN
• PMA/510(K) Number: K173499
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 10/20/2020

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 Model Number: 0580-1-372
• Device Catalogue Number: 0580-1-372
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 09/24/2020
• Initial Report FDA Received Date: 10/20/2020
• 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