MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH CITATION TMZF HA STEM #5 RIGHT; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED

Model Number	6265-5115
Medical Device Problem Codes	Difficult to Insert (1316); Positioning Problem (3009)
Health Effect - Clinical Codes	No Consequences Or Impact To Patient (2199); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/13/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Review of the product history records indicate devices were manufactured and accepted into final stock with no relevant reported discrepancies.There have been no other 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.Device not returned.
Event or Problem Description
Broach sat flush with neck resection and the stem sat proud by at least 4mm.
Additional Manufacturer Narrative
Upon review, h1 was noted incorrect.This report is to correct h1.Device not returned.
Event or Problem Description
Broach sat flush with neck resection and the stem sat proud by at least 4mm.

• Brand Name: CITATION TMZF HA STEM #5 RIGHT
• Common Device Name: PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED
• Manufacturer (Section D): STRYKER ORTHOPAEDICS-MAHWAH; 325 corporate drive; mahwah NJ 07430
• MDR Report Key: 8152523
• Report Number: 0002249697-2018-03981
• Device Sequence Number: 19227369
• Product Code: LPH
• UDI-Device Identifier: 07613153074380
• UDI-Public: 07613153074380
• Combination Product (Y/N): N
• Initial Reporter State: NM
• Initial Reporter Country: US
• PMA/510(K) Number: K121308
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: health professional,other
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 12/29/2020

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: 02/28/2023
• Device Model Number: 6265-5115
• Device Catalogue Number: 6265-5115
• Device Lot Number: 60826202
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 11/13/2018
• Supplement Date Received by Manufacturer: 12/23/2020
• Initial Report FDA Received Date: 12/11/2018
• Supplement Report FDA Received Date: 12/29/2020
• 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: 72 YR