MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH LFIT MORSE TAPER HEAD; IMPLANT

Catalog Number 01-2605

Device Problems Migration or Expulsion of Device (1395); Device Slipped (1584); No Apparent Adverse Event (3189)

Patient Problems Injury (2348); No Code Available (3191)

Event Date 01/16/2015

Event Type  Injury  

Event Description

The acetabular component was loose and migrated as seen in the x-ray film requiring revision of cup, liner, and femoral head.The cup and liner were replaced with depuy implants and femoral head was replaced by a morse taper/c-taper adapter sleeve to accommodate a ceramic head with +7.5mm offset.

Manufacturer Narrative

Catalog number unknown at this time.Device description reported as unknown trident multi hole acetabular shell.The surgeon mentioned this being the patient's 2nd or 3rd revision on the same hip.It cannot be confirmed if previous revisions were of stryker devices.Additional information has been requested and if received will be submitted in a follow up report upon completion of the investigation.Discarded.

Manufacturer Narrative

A stryker lfit morse taper head was mated with a zimmer liner.As stated in the ifu supplied with the device "howmedica osteonics corp.Strongly advises against the use of another manufacturer¿s tapered femoral stem or acetabular component with any howmedica osteonics femoral bearing head component.Any such use will negate the responsibility of howmedica osteonics corp.For the performance of the resulting mixed component implant." therefore, the use of a zimmer liner with the stryker head is not sanctioned by stryker and as such is considered an off label application of the device.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

The acetabular component was loose and migrated as seen in the x-ray film requiring revision of cup, liner, and femoral head.The cup and liner were replaced with depuy implants and femoral head was replaced by a morse taper/c-taper adapter sleeve to accommodate a ceramic head with +7.5mm offset.

• Brand Name: LFIT MORSE TAPER HEAD
• Type of Device: IMPLANT
• 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: william hanna ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 4553870
• MDR Text Key: 19317152
• Report Number: 0002249697-2015-00500
• Device Sequence Number: 1
• Product Code: LWJ
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K993601
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Health Professional,health professional,oth
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 01/16/2015

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 Expiration Date: 07/31/2005
• Device Catalogue Number: 01-2605
• Device Lot Number: 57419701
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 01/16/2015
• Initial Date FDA Received: 02/27/2015
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 10/29/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/26/2000
• 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): Required Intervention
• Patient Age: 46 YR