MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH UNKNOWN_RECONSTRUCTIVE_PRODUCT; IMPLANT

Catalog Number UNK_REC

Device Problems Failure to Align (2522); Mechanics Altered (2984)

Patient Problem No Information (3190)

Event Date 12/17/2013

Event Type  Injury  

Event Description

It was reported that there was a primary done after surgery; it was noted that the cup was misaligned.The surgeon went back in same day and repositioned the cup and changed the head and liner.

Manufacturer Narrative

The catalog number and lot code were not provided.The device was reported as an unknown shell.Additional information has been requested and if received, will be provided in the supplemental report upon completion of the investigation.Device not available.

• Brand Name: UNKNOWN_RECONSTRUCTIVE_PRODUCT
• 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: sandra spokane ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 3778115
• MDR Text Key: 20717785
• Report Number: 0002249697-2014-01545
• Device Sequence Number: 1
• Product Code: KWY
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 12/17/2013

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/29/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: UNK_REC
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/17/2013
• 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): Required Intervention
• Patient Age: 65 YR
• Patient Weight: 90