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

Catalog Number UNK_SHC

Device Problems Metal Shedding Debris (1804); Patient-Device Incompatibility (2682)

Patient Problems Pain (1994); Tissue Damage (2104); Toxicity (2333); Ambulation Difficulties (2544); Test Result (2695)

Event Date 04/21/2011

Event Type  Injury  

Event Description

The patient had 2 good years with her primary left hip and then she began experiencing pain.The surgeon took x-rays which looked did not reveal any issues.The patient continued to have pain so bloodwork was run and it was determined that there were high levels of cocr in her blood.A revision surgery was immediately scheduled.After the revision surgery the doctor noted that the patient lost a lot of muscle.The patient can no longer walk without some sort of assistance, i.E.Cane, walker and possibility of a wheel chair in the future.The patient's primary right hip has no issues.

Manufacturer Narrative

Catalog number is unknown at this time.The device was reported as an unknown accolade tmzf left hip.Should additional information become available, the evaluation summary will be submitted in a supplemental report.Not returned.

• Brand Name: UNKNOWN_CORK_PRODUCT
• Type of Device: 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: anna jusinski ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 4610712
• MDR Text Key: 20787091
• Report Number: 0002249697-2015-00771
• Device Sequence Number: 1
• Product Code: JDI
• 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: 02/19/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/17/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: UNK_SHC
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 02/19/2015
• 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): Required Intervention
• Patient Age: 87 YR
• Patient Weight: 57