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

Catalog Number UNK_REC

Device Problems Positioning Problem (3009); Noise, Audible (3273)

Patient Problems Fall (1848); Pain (1994); Complaint, Ill-Defined (2331)

Event Date 01/01/2010

Event Type  Injury  

Event Description

The patient suffered a fall and broke the ball off of the left femur in 2010.He had a partial hip implanted.He is in pain everyday since the surgery and the hip clicks very loudly.It sounds and feels like it goes in and out of place.The patient had a second opinion that stated he needs a revision.The patient is now on medicaid disability and is having trouble finding a revision surgeon.

Manufacturer Narrative

Catalog number unknown at this time.Device description reported as unknown stryker partial hip.Additional information has been requested and if received will be submitted in a follow up report upon completion of the investigation.Device remains implanted.

• 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: rita intorrella ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 4772569
• MDR Text Key: 5948418
• Report Number: 0002249697-2015-01536
• Device Sequence Number: 1
• Product Code: MEH
• 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,Consumer
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 04/17/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/14/2015
• 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
• Date Manufacturer Received: 04/17/2015
• 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
• Patient Age: 61 YR
• Patient Weight: 65