MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH EXETER. FEMORAL HEAD; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, CEMENTED

Model Number	0586-0-028
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	03/30/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
A patient specific implant request for was received for the patient's right hip.Noted on the form: "[competitor] liner wear acetabular side requiring revision of liner and head.Old exeter taper heads." stem is noted to be well-fixed.Planned date of surgery (b)(6)2023.
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.An evaluation of the device cannot be performed as the device was not returned to the manufacturer.Should additional information become available it will be reported in a supplemental report upon completion of the investigation.

• Brand Name: EXETER. FEMORAL HEAD
• Common Device Name: PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, CEMENTED
• Manufacturer (Section D): STRYKER ORTHOPAEDICS-MAHWAH; 325 corporate drive; mahwah NJ 07430
• Manufacturer (Section G): STRYKER ORTHOPAEDICS-CORK; ida industrial estate; carrigtwohill NA ; EI NA
• Manufacturer Contact: joann ripoli ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 16821560
• Report Number: 0002249697-2023-00432
• Device Sequence Number: 15168188
• Product Code: JDI
• UDI-Device Identifier: 04546540153869
• UDI-Public: 04546540153869
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K121308
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 04/27/2023

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: 0586-0-028
• Device Catalogue Number: 0586-0-028
• Device Lot Number: GZ607957
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 03/30/2023
• Initial Report FDA Received Date: 04/27/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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: Other
• Patient Age: 71 YR
• Patient Sex: Male
• Patient Weight: 97 KG