MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH LFIT MORSE TAPER HEAD; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, UNCEMENTED

Model Number 01-2810

Device Problem Insufficient Information (3190)

Patient Problems Bone Fracture(s) (1870); Failure of Implant (1924); Ambulation Difficulties (2544)

Event Date 10/09/2020

Event Type  Injury  

Manufacturer Narrative

If additional information is received, it will be provided in a supplemental report upon completion of the investigation.Device not available.

Event Description

As reported: "right hip revision due to trunnion break.All implants listed below (stem, head, liner, and shell) were explanted.No more information is available per doctor." update: "shell revised to change position.No allegations against liner.".

Manufacturer Narrative

Reported event:  an event regarding stem crack/fracture (trunnion break) involving a metal head was reported.  conclusion:  based on the information provided there is no indication or allegation that the device reported in this investigation contributed to the event.It was reported that the patient was revised due to trunnion break and the shell was revised to change its position.The femoral head was assembled onto the stem and was revised with the stem.There is no allegation against the femoral head.No further investigation is required at this time.If additional information becomes available to indicate further evaluation is warranted, this record will be reopened.

Event Description

As reported: "right hip revision due to trunnion break.All implants listed below (stem, head, liner, and shell) were explanted.No more information is available per doctor." update: "shell revised to change position.No allegations against liner.".

• Brand Name: LFIT MORSE TAPER HEAD
• Type of Device: PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, UNCEMENTED
• Manufacturer (Section D): STRYKER ORTHOPAEDICS-MAHWAH; 325 corporate drive; mahwah NJ 07430
• MDR Report Key: 10789180
• MDR Text Key: 214763586
• Report Number: 0002249697-2020-02330
• Device Sequence Number: 1
• Product Code: LWJ
• UDI-Device Identifier: 07613327016154
• UDI-Public: 07613327016154
• Combination Product (y/n): N
• PMA/PMN Number: K993601
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Type of Report: Initial,Followup
• Report Date: 12/21/2020

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
• Device Operator: Health Professional
• Device Model Number: 01-2810
• Device Catalogue Number: 01-2810
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 10/09/2020
• Initial Date FDA Received: 11/04/2020
• Supplement Dates Manufacturer Received: 11/24/2020
• Supplement Dates FDA Received: 12/21/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 82 YR
• Patient Weight: 110