MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH SYSTEM 12 CROSSFIRE 10° 28MM; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED

Model Number	6352-5-073
Medical Device Problem Code	Naturally Worn (2988)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	02/22/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported through the submission of a revision implant sheet that the patient's right hip was revised.A screw and poly insert were implanted.Update 23/february/2023: patient was revised due to wear of the poly.The poly and head were removed and a new poly implanted with the thought that a femoral head to fit in it would be available.A femoral head for the liner was not available, so they wasted the liner, implanted a 28mm liner, and re-implanted the explanted head.Rep confirmed that no further information will be released by the hospital or surgeon.
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.

• Brand Name: SYSTEM 12 CROSSFIRE 10° 28MM
• Common Device Name: PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED
• Manufacturer (Section D): STRYKER ORTHOPAEDICS-MAHWAH; 325 corporate drive; mahwah NJ 07430
• Manufacturer (Section G): STRYKER ORTHOPAEDICS-MAHWAH; 325 corporate drive; mahwah NJ 07430
• Manufacturer Contact: anna ryan ; raheen business park; limerick NA ; EI NA ; 61498200
• MDR Report Key: 16572347
• Report Number: 0002249697-2023-00281
• Device Sequence Number: 17671584
• Product Code: LPH
• UDI-Device Identifier: 07613327038637
• UDI-Public: 07613327038637
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K993352
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Explanted Year: 2023
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 03/20/2023

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: 6352-5-073
• Device Catalogue Number: 6352-5-073
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 02/22/2023
• Initial Report FDA Received Date: 03/20/2023
• 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: Hospitalization; Required Intervention
• Patient Age: 86 YR
• Patient Sex: Female