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

Model Number	01-2810
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Codes	Bone Fracture(s) (1870); Failure of Implant (1924); Ambulation or Postural Difficulties (2544)
Date of Event	10/09/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
If additional information is received, it will be provided in a supplemental report upon completion of the investigation.Device not available.
Event or Problem 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.".
Additional 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 or Problem 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
• Common Device Name: PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, UNCEMENTED
• Manufacturer (Section D): STRYKER ORTHOPAEDICS-MAHWAH; 325 corporate drive; mahwah NJ 07430
• MDR Report Key: 10789180
• Report Number: 0002249697-2020-02330
• Device Sequence Number: 2988439
• Product Code: LWJ
• UDI-Device Identifier: 07613327016154
• UDI-Public: 07613327016154
• Combination Product (Y/N): N
• Initial Reporter State: MN
• Initial Reporter Country: US
• PMA/510(K) Number: K993601
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2000
• Device Explanted Year: 2020
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 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
• Operator of Device: Health Professional
• Device Model Number: 01-2810
• Device Catalogue Number: 01-2810
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 10/09/2020
• Supplement Date Received by Manufacturer: 11/24/2020
• Initial Report FDA Received Date: 11/04/2020
• Supplement Report FDA Received Date: 12/21/2020
• 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: Hospitalization; Required Intervention
• Patient Age: 82 YR
• Patient Weight: 110