MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH CITATION TMZF HA SHORT SIZE#7R; PROSTHESIS, HIP, SEMI-CONSTRAINED, UNCEMENTED, METAL/POLYMER, NON-POROUS, CALICU

Model Number 6265-5217

Device Problems Detachment of Device or Device Component (2907); Noise, Audible (3273)

Patient Problem Ambulation Difficulties (2544)

Event Date 07/01/2022

Event Type  Injury  

Event Description

It was reported through the filing of a lawsuit that allegedly the patient was implanted with an lfit cocr v40 femoral head on his right hip on or about (b)(6) 2007.Allegedly in (b)(6) 2022 patient developed an audible "clicking" sound in his right hip upon movement of that hip and subsequent diagnostic imaging studies and aspiration of his right hip revealed early signs of a similar breakdown (dissociation) which was previously observed on his left hip.It is further alleged that in (b)(6) 2022 he was required to undergo a revision surgery.

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.Device not returned to the manufacturer.

• Brand Name: CITATION TMZF HA SHORT SIZE#7R
• Type of Device: PROSTHESIS, HIP, SEMI-CONSTRAINED, UNCEMENTED, METAL/POLYMER, NON-POROUS, CALICU
• 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: arokiya raj ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 16433969
• MDR Text Key: 310130623
• Report Number: 0002249697-2023-00187
• Device Sequence Number: 1
• Product Code: MEH
• UDI-Device Identifier: 07613154316106
• UDI-Public: 07613154316106
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K053528
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 02/24/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/24/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 6265-5217
• Device Catalogue Number: 6265-5217
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 01/30/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 79 YR
• Patient Sex: Male