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

Model Number 01-2205

Device Problem Device Difficult to Setup or Prepare (1487)

Patient Problem Injury (2348)

Event Date 01/23/2020

Event Type  Injury  

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.

Event Description

Liner replacement surgery for a patient who underwent tha on (b)(6) 1998.Since the production of a 22 mm diameter liner for replacement was discontinued, 28 mm and 32 mm liners were prepared.I tried to remove the head from the stem but could not.Since no damage was observed in the implanted 22 mm diameter liner, it was washed and closed as it was.After all, nothing new implanted.

• 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
• Manufacturer (Section G): STRYKER ORTHOPAEDICS-MAHWAH; 325 corporate drive; mahwah NJ 07430
• Manufacturer Contact: collin neitzel ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 9728431
• MDR Text Key: 188509934
• Report Number: 0002249697-2020-00362
• Device Sequence Number: 1
• Product Code: LWJ
• UDI-Device Identifier: 07613327016093
• UDI-Public: 07613327016093
• Combination Product (y/n): N
• Reporter Country Code: JP
• PMA/PMN Number: K993601
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,other
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 02/19/2020

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: 01-2205
• Device Catalogue Number: 01-2205
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 01/23/2020
• Initial Date FDA Received: 02/19/2020
• 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