MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH UNKNOWN 2047-XXXX(ALUMINA CERAMIC LINER); HIP IMPLANT

Catalog Number UNK_SHC

Device Problem Device Dislodged or Dislocated (2923)

Patient Problem No Code Available (3191)

Event Date 10/30/2015

Event Type  Injury  

Manufacturer Narrative

Should additional information become available, it will be provided in a supplemental report upon completion of the investigation.

Event Description

This is from conference presentation in (b)(6).It was reported that there was confirmation of dislocation after the medical procedure.

• Brand Name: UNKNOWN 2047-XXXX(ALUMINA CERAMIC LINER)
• Type of Device: HIP IMPLANT
• Manufacturer (Section D): STRYKER ORTHOPAEDICS-MAHWAH; 325 corporate drive; mahwah NJ 07430
• Manufacturer (Section G): STRYKER ORTHOPAEDICS-CORK; ida industrial estate; carrigtwohill NA
• Manufacturer Contact: sandra spokane ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 5248544
• MDR Text Key: 32095717
• Report Number: 0002249697-2015-04045
• Device Sequence Number: 1
• Product Code: LPF
• Combination Product (y/n): N
• 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: 11/10/2015

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: Lay User/Patient
• Device Catalogue Number: UNK_SHC
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/10/2015
• Initial Date FDA Received: 11/24/2015
• 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): Other