MAUDE Adverse Event Report: ZIMMER, INC.; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED

Model Number	6250-65-40
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/17/2023
Type of Reportable Event	Malfunction
Event or Problem Description
Bone screw broke during procedure.

• Brand Name: NA
• Common Device Name: PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED
• Manufacturer (Section D): ZIMMER, INC.; 1800 w. center street; warsaw IN 46580
• MDR Report Key: 18739446
• Report Number: 18739446
• Device Sequence Number: 17769536
• Product Code: LPH
• UDI-Device Identifier: 00889024119840
• UDI-Public: (01)00889024119840(17)330618(10)J7548922
• Combination Product (Y/N): N
• Initial Reporter State: VA
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 11/06/2023
• Report Date (Section F): 11/06/2023

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: 6250-65-40
• Device Catalogue Number: 00-6250-065-40
• Device Lot Number: J7548922
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Event Location: Hospital
• Date Report to Manufacturer: 02/20/2024
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 02/20/2024
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Patient Age: 81 YR
• Patient Sex: Male
• Patient Weight: 115 KG
• Date Report Sent to FDA: 11/06/2023